European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Skin closure methods after single port laparoscopic surgery: a randomized clinical trial Sue Yeon Park a, Kye Hyun Kim b, Jin-Sung Yuk c, Hyun Young Ji c, Jung Hun Lee c,* a
The Department of Obstetrics and Gynecology, Cheil General Hospital and Women’s Healthcare Center, Seoul, Republic of Korea The Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea c The Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Republic of Korea b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 9 December 2014 Received in revised form 24 February 2015 Accepted 5 March 2015
Objective: To compare postoperative cosmetic outcomes according to different umbilical closure methods after single port laparoscopic surgery (SP-LS). Study design: A total of 138 women who were scheduled to receive elective SP-LS were randomized to undergo closure of the umbilical incision with either a subcutaneous suture only without subcuticular skin suture (case group, n = 68) or both a subcutaneous suture and subcuticular skin suture (control group, n = 70) after fascial closure. At postoperative months 1 and 3, the umbilical scar was evaluated using the Vancouver scar scale (VSS), the patient and observer scar assessment scale, and a visual analog scale (VAS). Overall satisfaction with scar cosmesis and surgery was assessed with the VAS. Results: There was no significant difference in the clinical characteristics and operative data between the groups. The objective and subjective scar assessments and the overall satisfaction with scar cosmesis were not different between the groups. In the control group, four (5.7%) women experienced wound discharge and were treated with conservative treatments and delayed closure. In women who completed the first and second assessments, the changes in the scar assessment and overall satisfaction with the scar according to time after surgery were not different in either group, but the patient scar assessment scale in both groups and the VSS in the case group improved. Conclusions: After SP-LS, the approximation of the fascia and subcutaneous layer seems to be enough for the closure of an umbilical incision. Skin closure with subcuticular sutures did not improve the postoperative cosmetic outcomes and might lead to impaired wound healing. However, large randomized trials with various closure techniques and materials are needed to confirm this finding. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Cosmesis Laparoscopy Scar assessment scale Single port surgery
Introduction In various diseases in the gynecologic field, many studies on single port laparoscopic surgery (SP-LS) have been reported [1–3]. SP-LS has some theoretical advantages, including better cosmetic outcome, less postoperative pain, shorter hospital stays, and improved recovery time [4,5]. Of these advantages, the most noticeable benefit of SP-LS might be the cosmetic improvement via a hidden umbilical incision [1,3]. Postoperative scar cosmesis is a critical issue for women, especially young women, because the scars can induce chronic symptoms associated with the wound
* Corresponding author. Tel.: +82 10 6316 7470; fax: +82 2 2007 1466. E-mail address: [email protected] (J.H. Lee). http://dx.doi.org/10.1016/j.ejogrb.2015.03.014 0301-2115/ß 2015 Elsevier Ireland Ltd. All rights reserved.
(such as pain, tenderness, and itching). The negative impact of scars can also have psychological consequences [6,7]. The final appearance and function of postoperative scars are decided by three factors: patient factors, wound factors, and technical factors. Technical factors are completely within the control of the surgeon and are influenced by the closure material and technique of skin apposition [8]. To our knowledge, however, there have been no studies on the standard closure method of umbilical incisions to maximize the cosmetic benefit of SP-LS. Therefore, to provide laparoscopists with evidence-based guidance on the optimal closure method for transumbilical incision, we designed this randomized trial to compare the cosmetic outcome of the umbilical scar according to different closure methods (subcutaneous suture without subcuticular skin suture versus subcutaneous suture with subcuticular skin suture). The primary outcome was to compare the
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
cosmetic outcomes using standardized and validated scar assessment tools, and the secondary outcome was to evaluate the wound complication rate associated with these skin closure methods.
9
diabetes mellitus, severe malnutrition, and diseases requiring chronic corticosteroid use. Operative technique
Materials and methods This prospective randomized study was carried out in women who were scheduled to receive elective SP-LS from August 2012 to March 2013 at Kangbuk Samsung Hospital in Seoul, Republic of Korea. This study was approved by our Institutional Review Board, and all participants provided informed consent. The inclusion criteria were women (age between 18 and 70 years) who had undergone surgery for a benign gynecological disease with a uterus 16 weeks gestational size and/or adnexal mass 8 cm in size, and carcinoma in situ or micro-invasive carcinoma of the uterine cervix. The exclusion criteria included psychiatric disorders, an American Society of Anesthesiologist (ASA) classification above 3, malignant diseases, tattoos and piercing in the umbilicus, history of keloid scarring, previous umbilicus scar, hypersensitivity to the nylon suture material, or medical conditions that could affect wound healing, such as
The port placement system of SP-LS was established as described in our previous reports (Fig. 1) [1–3]. SP-LS was performed using a trans-umbilical GelPoint (Applied Medical, Rancho Santa Margarita, CA, USA) and articulating instruments. After the main operations, the fascia layer of the umbilical incision was approximated by continuous interlocking sutures with 0 absorbable multifilament suture material (Vicryl1, EthiconEthicon Inc., Somerville, NJ), and the subcutaneous layer was approximated by several interrupted sutures with 2-0 absorbable multifilament suture material (Polysorb1, Syneture, Mansfield, MA). The participating patients were randomized to undergo skin closure of their umbilical incision with either subcutaneous suture only without subcuticular skin suture (case group) or both subcutaneous suture and subcuticular skin suture (control group). Only the control group underwent continuous subcuticular suture for skin closure with 3-0 non-absorbable monofilament suture (Nylon1, Woori, Seoul), and the case group did
Fig. 1. (A) Bilateral borders of the umbilicus were clamped and elevated using hemostatic forceps. (B) A 15–20 mm vertical transumbilical skin incision was made by a scalpel. (C) Incision was extended to the peritoneum using a monopolar coagulator. (D) The abdominal wall was lifted using Army–Navy retractors and the incision of the fascia layer was extended caudally and cephalically. (E) The wound retractor of the GelPoint (Applied Medical, Rancho Santa Margarita, CA) was introduced and positioned. (F) The GelPort platform was latched to the retractor.
10
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
not. The closure of skin and subcutaneous layer was performed by three second or third year residents. The wound dressing was carried out daily using povidone-iodine and the non-absorbable sutures were removed on the seventh postoperative day. Scar assessment Scar assessment was carried out at postoperative weeks 5 and 13. The objective scar assessment was performed using the Vancouver Scar scale (VSS) and the observer scar assessment scale (OSAS) of the Patient and Observer Scar Assessment Scale (POSAS) [9,10]. Subjective scar assessment was performed via the patient scar assessment scale (PSAS) of the POSAS and visual analog scale (VAS) [10,11]. The VSS rated four physical characteristics of the scar: vascularity, pigmentation, pliability, and height. Each variable had ranked subscales that could be summed to obtain a total score ranging from 0 to13, where 0 represented normal skin. In the POSAS, each variable used a 10-point scoring system, where 1 represented normal skin. The OSAS of the POSAS rated five variables: vascularity, pigmentation, thickness, relief, and pliability. The rating of individual variables could be summed to obtain a total score ranging from 5 to 50, where 5 represented normal skin. The PSAS of the POSAS includes six domains (pain, itchiness, color, stiffness, thickness, and irregularity). A summary score of 6 corresponds to normal skin, and 60 is the worst scar. All patients were asked to rate their overall satisfaction with the scars and with the surgery using a 10 cm visual analogue scale. Sample size and randomization We calculated the sample size based on a non-inferiority sample size formula with a-error of 0.05, b-error of 0.20, and a noninferiority margin 10 mm on the VAS score, and the minimum sample size was determined to be 37 patients for each arm. Assuming an attrition rate of 40%, at least 124 subjects needed to be randomized. The patients were randomly assigned to either the case or control group by the block randomization method. For participant allocation, a computer-generated list of random numbers was used.
The randomization sequence was generated using Excel 2010 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using block sizes of 4 by an independent doctor. Randomization took place after closure of fascia at operation room using the cards in opaque envelopes labeled consecutively with study numbers. A flowchart of the study participants is provided in Fig. 2. Statistical analysis The data are expressed as the mean standard deviation or median (range). Each variable was confirmed to follow a normal (Gaussian) distribution with the Shapiro–Wilk test. An unpaired t-test was used to compare the parametric variables. A Mann–Whitney U test was used to compare nonparametric variables. A paired T-test was used to compare scores at postoperative months 1 and 3 in each individual. P < 0.05 indicated a significant difference. All analyses were performed using the Statistical Package for Social Sciences (SPSS), version 17.0 for Windows (SPSS Inc., Chicago, IL, USA). Results There were no significant differences in the clinical characteristics and operative data between the groups (Table 1). In the control group, four (5.7%) women experienced discharge from the umbilical wound after the stitches were removed and were treated with conservative treatments or delayed closure without any sequelae. In the case group, single port laparoscopic primary closure was performed in two women with intraoperative bladder laceration. Other complications were resolved by conservative treatments. Table 2 shows a comparison of cosmetic outcomes between the groups. With respect to the objective and subjective scar assessments and the overall satisfaction for scar cosmesis and surgery, there were no differences between the groups. In women that completed the first and second scar assessments, the changes in scar assessment results, overall satisfaction with the scar (VAS for scar), and the overall satisfaction with the surgery (VAS for surgery) according to the time interval were not different
Fig. 2. Flowchart detailing the study participants. Case group = women underwent skin closure with only subcutaneous suture; control group = women underwent skin closure with a subcutaneous and subcuticular suture.
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
11
Table 1 Clinical characteristics and operative data. Mean SD/number (%)/mean (range)
Characteristics
Number of patients Age of patients (years) Body mass index (kg/m2) Parity Number of patients with previous abdominal surgery
P value
Case group
Total 134 40.98 8.97 22.88 3.52 1.1 (0–3) 47 (34.1)
Control group
68 41.80 8.59 22.64 3.61 1.2 (0–3) 21 (30.9)
70 40.17 9.30 23.10 3.44 1.0 (0–3) 26 (37.1)
33 7 15 10 3
31 3 18 13 5
0.29a 0.45a 0.49a 0.44b 0.59b
Surgery performed LAVH LAVH with adnexal surgery Adnexal surgery LM LM with adnexal surgery
64 10 32 23 8
Operating time (min)
(47.0) (7.2) (23.2) (16.7) (5.8)
118 (65–265)
Hospital stay
118 (65–265)
3.30 (1–12)
Complication Intraoperative complications Bladder injury Postoperative complications Transfusion Postoperative fever Ileus Wound complication
(48.5) (10.3) (22.1) (14.7) (4.4)
3.22 (1–6)
26 (21.7)
13 (19.1)
2 (1.4)
2 (2.9)
19 4 1 4
(13.8) (2.9) (0.7) (2.9)
(44.3) (4.3) (25.7) (18.6) (7.1)
117 (75–190)
0.85a
3.38 (3–12)
0.33a
17 (24.3)
0.94b
0 (0)
9 (13.2) 2 (2.9) 0 0
10 2 1 4
(14.3) (2.9) (1.4) (5.7)
Case group = women underwent skin closure with only Subcutaneous Suture; control group = women underwent skin closure with subcutaneous and subcuticular suture. a According to an unpaired t test. b According to a Pearson x2 test.
in each group, but the PSAS scores in both groups and the VSS scores in the case group improved at the second assessment (at postoperative week 13) compared to the initial assessment (at postoperative week 5) (Table 3). The results of this study were reported according to the ontreatment analysis. Comment Because concern about postoperative cosmetic outcomes has been increasing, many studies have been published on various methods of skin closure after surgery [12–14]. Recently, SP-LS has been performed in various surgical fields, and many studies have reported its safety, feasibility, and efficacy [2,3,8,15,16]. However, there have been no studies on skin closure methods following SP-LS, despite the anatomical and physical characteristics of the umbilicus. Studies have reported that, compared with conventional laparoscopic surgery, SP-LS decreases postoperative pain and improves cosmetic outcome [1,8,15,16]. The results of this study, the first report on skin closure methods in SP-LS, showed that skin closure using a subcuticular suture does not improve the cosmetic
outcome of the umbilical incision compared with not performing it. A subcuticular suture might cause wound complications, though our results for this complication were not statistically significant. The approximation of the fascia and subcutaneous layer appears to be sufficient for the closure of an umbilical incision. These findings are attributable the anatomical and physical characteristics of the umbilicus. Hypertrophic scars are known to occur at sites that are highly mobile and under high tension, such as the anterior chest, suprapubic region, and upper arm, whereas the umbilicus is immobile and is influenced by weak mechanical forces [17]. Furthermore, if the umbilical stalk is properly reattached to the fascia with an anchoring suture, the apposition of the edges of the incision can be ensured. Due to a natural deep dimple of the umbilicus, a subcuticular skin suture is technically difficult and time consuming. Thus, the increased wound complication rate in the control group could be due to impaired wound healing caused by excessive tissue manipulation for a relatively long period of time. The final cosmesis of the wounds was assessed at 3 months. We previously reported a comparative cross-sectional study on cosmetic outcomes after single port or conventional laparoscopic surgery; the mean interval from operation to scar assessment was
Table 2 Scar assessment results. Variable
Number of patients VSS POSAS OSAS PSAS VAS for scar cosmesis VAS for surgery
5 Weeks postoperatively
P value
Cohen’s d (95% CI)
13 Weeks postoperatively
P value
Cohen’s d (95% CI)
Case group
Control group
Case group
Control group
68
66
49
38
4.54 2.24 15.75 7.43 14.66 7.82 8.77 1.80
4.04 2.31 14.16 7.18 17.31 9.94 8.80 1.48
0.21 0.21 0.89 0.93
0.22 ( 0.12, 0.56) 0.22 ( 0.13, 0.56) 0.3 ( 0.64, 0.05) 0.02 ( 0.36, 0.32)
3.98 2.56 14.14 8.22 12.38 7.85 9.00 1.62
3.44 2.32 12.47 7.21 13.18 7.92 9.09 1.25
0.32 0.33 0.64 0.76
0.22 ( 0.21, 0.65) 0.21 ( 0.22, 0.65) 0.1 ( 0.53, 0.33) 0.06 ( 0.49, 0.37)
8.30 2.14
8.37 1.85
0.85
0.03 ( 0.38, 0.31)
8.48 2.04
8.43 2.06
0.92
0.02 ( 0.41, 0.45)
Case group = women underwent skin closure with only subcutaneous suture; control group = women underwent skin closure with subcutaneous and subcuticular suture; CI = Confidence Interval; OSAS = observer scar assessment scale; POSAS = patient and observer scar assessment scale; PSAS = patient scar assessment scale; VAS for scar cosmesis = visual analog scale represents patients’ overall satisfaction with scar cosmesis; VAS for surgery = visual analog scale represents patients’ overall satisfaction with surgery; VSS = Vancouver Scar Scale. According to an unpaired t test.
12
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
Table 3 Change in assessment results according to time interval after surgery. Variable
Number of patients VSS POSAS OSAS PSAS VAS for scar cosmesis VAS for surgery
Case group
P value
Cohen’s d (95% CI)
Control group
P value
5 Weeks postoperatively
13 Weeks postoperatively
5 Weeks postoperatively
13 Weeks postoperatively
49
49
38
38
4.49 2.29 15.59 7.57 15.00 8.19 8.63 1.99
3.98 2.56 14.14 8.22 12.38 7.85 9.00 1.62
0.30 0.31 < 0.01 0.07
0.21 ( 0.19, 0.61) 0.18 ( 0.22, 0.59) 0.33 ( 0.08, 0.73) 0.2 ( 0.61, 0.2)
4.63 2.29 14.94 6.68 16.97 11.18 8.81 1.80
3.44 2.32 12.47 7.21 13.18 7.92 9.09 1.25
< 0.01 0.09 0.04 0.13
8.21 2.28
8.48 2.04
0.12
0.12 ( 0.53, 0.28)
8.28 2.11
8.43 2.06
0.58
Cohen’s d (95% CI)
0.52 0.36 0.39 0.18
(0.05, 0.98) ( 0.11, 0.82) ( 0.07, 0.85) ( 0.64, 0.28)
0.07 ( 0.53, 0.39)
Data are expressed as the mean standard deviation. Case group = women underwent skin closure with only subcutaneous suture; control group = women underwent skin closure with subcutaneous and subcuticular suture; CI = Confidence Interval; OSAS = observer scar assessment scale; POSAS = patient and observer scar assessment scale; PSAS = patient scar assessment scale; VAS for scar cosmesis = visual analog scale represents patients’ overall satisfaction with scar cosmesis; VAS for surgery = visual analog scale represents patients’ overall satisfaction with surgery; VSS = vancouver scar scale. According to a paired t test.
64.8 weeks (range, 26.7 to 144 weeks), and the scar was evaluated with the same tools that were used in the current study [1]. Comparing the scores from the assessment tools at postoperative week 15 in the current study and those in our previous report, there were no statistically significant differences. Based on this result, although scar maturation continues to 52 weeks after surgery [18], we believe that the follow-up time of our study is acceptable. In addition, scar assessment and patient satisfaction with the scar and surgery did not significantly improve over time, as shown in Table 3. Considering the results of our previous study with a relatively long follow-up, it can be assumed that there would be no significant difference between the groups if further observations were conducted. However, the PSAS scores in both groups improved during the time interval. This result is thought to be because the PSAS of the POSAS includes two domains (pain and itchiness) that improved unlike other domains of the POSAS. The current study has potential limitations. First, there were variations in the surgeons’ closure techniques and inter-observer bias because three physicians performed the closure of and evaluation of the umbilical wounds. Second, we used only one type of device (trans-umbilical GelPort). Therefore, the effects of the device for SP-LS on wound scarring were not considered. Third, we did not assess other skin closure techniques, such as stables or skin adhesives. Although skin adhesives are costly, we believe that they should be a choice for umbilical wound closure in SP-LS because they can be applied quickly, patients may shower during the immediate postoperative period, they need not to be removed, and umbilical wounds have irregular margins [14]. Lastly, an evaluation of whether the subcutaneous suture could also be omitted was not performed. In conclusion, this study shows that in SP-LS, the ideal closure method of an umbilical incision includes approximation of the fascia and subcutaneous layer, and skin closure using subcuticular sutures might be redundant, leading to impaired wound healing. However, large randomized trials with various techniques and materials are needed to confirm this result. Conflict of interest statement This article was not supported by any financial funds and not affiliated with the instrument company referred to in the text. Condensation After single port laparoscopy, the approximation of the fascia and subcutaneous layer without skin suture seems to be enough for the closure of umbilical incision.
References
[1] Eom J.M., Ko J.H., Choi J.S., Hong J.H., Lee J.H.. A comparative cross-sectional study on cosmetic outcomes after single port or conventional laparoscopic surgery. Eur J Obstet Gynecol Reprod Biol 2013;167:104–9. [2] Lee J.H., Choi J.S., Jeon S.W., Son C.E., Hong J.H., Bae J.W.. A prospective comparison of single-port laparoscopically assisted vaginal hysterectomy using transumbilical GelPort access and multiport laparoscopically assisted vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol 2011;158:294–7. [3] Lee J.H., Choi J.S., Jeon S.W., Son C.E., Lee S.J., Lee Y.S.. Single-port laparoscopic myomectomy using transumbilical GelPort access. Eur J Obstet Gynecol Reprod Biol 2010;153:81–4. [4] Garg P., Thakur J.D., Raina N.C., Mittal G., Garg M., Gupta V.. Comparison of cosmetic outcome between single-incision laparoscopic cholecystectomy and conventional laparoscopic cholecystectomy: an objective study. J Laparoendosc Adv Surg Tech A 2012;22:127–30. [5] Santos B.F., Reif T.J., Soper N.J., Hungness E.S.. Effect of training and instrument type on performance in single-incision laparoscopy: results of a randomized comparison using a surgical simulator. Surg Endosc 2011;25:3798–804. [6] Vercelli S., Ferriero G., Sartorio F., Stissi V., Franchignoni F.. How to assess postsurgical scars: a review of outcome measures. Disabil Rehabil 2009;31: 2055–63. [7] Gangl O., Hofer W., Tomaselli F., Sautner T., Fugger R.. Single incision laparoscopic cholecystectomy (SILC) versus laparoscopic cholecystectomy (LC)-a matched pair analysis. Langenbecks Arch Surg 2011;396:819–24. [8] Kim T.J., Lee Y.Y., Cha H.H., et al. Single-port-access laparoscopic-assisted vaginal hysterectomy versus conventional laparoscopic-assisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc 2010;24: 2248–52. [9] Baryza M.J., Baryza G.A.. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil 1995;16:535–8. [10] Draaijers L.J., Tempelman F.R., Botman Y.A., et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg 2004;113:1960–5 (discussion 6–7). [11] Duncan J.A., Bond J.S., Mason T., et al. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg 2006;118:909–18. [12] Cromi A., Ghezzi F., Gottardi A., Cherubino M., Uccella S., Valdatta L.. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol 2010;203. 36 e1-36 e8. [13] Dowson C.C., Gilliam A.D., Speake W.J., Lobo D.N., Beckingham I.J.. A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures. Surg Laparosc Endosc Percutan Tech 2006;16:146–50. [14] Yang Y.L., Xiang Y.Y., Jin L.P., et al. Closure of skin incision after thyroidectomy through a supraclavicular approach: a comparison between tissue adhesive and staples. Scand J Surg 2013;102:234–40. [15] Chen Y.J., Wang P.H., Ocampo E.J., Twu N.F., Yen M.S., Chao K.C.. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol 2011;117:906–12. [16] Jung Y.W., Lee M., Yim G.W., et al. A randomized prospective study of singleport and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc 2011;25:2462–9. [17] Ogawa R., Mitsuhashi K., Hyakusoku H., Miyashita T.. Postoperative electronbeam irradiation therapy for keloids and hypertrophic scars: retrospective study of 147 cases followed for more than 18 months. Plast Reconstr Surg 2003;111:547–53 (discussion 54–55). [18] Brown N.J., Smyth E.A., Cross S.S., Reed M.W.. Angiogenesis induction and regression in human surgical wounds. Wound Repair Regen 2002;10:245–51.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Skin closure methods after single port laparoscopic surgery: a randomized clinical trial Sue Yeon Park a, Kye Hyun Kim b, Jin-Sung Yuk c, Hyun Young Ji c, Jung Hun Lee c,* a
The Department of Obstetrics and Gynecology, Cheil General Hospital and Women’s Healthcare Center, Seoul, Republic of Korea The Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea c The Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Republic of Korea b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 9 December 2014 Received in revised form 24 February 2015 Accepted 5 March 2015
Objective: To compare postoperative cosmetic outcomes according to different umbilical closure methods after single port laparoscopic surgery (SP-LS). Study design: A total of 138 women who were scheduled to receive elective SP-LS were randomized to undergo closure of the umbilical incision with either a subcutaneous suture only without subcuticular skin suture (case group, n = 68) or both a subcutaneous suture and subcuticular skin suture (control group, n = 70) after fascial closure. At postoperative months 1 and 3, the umbilical scar was evaluated using the Vancouver scar scale (VSS), the patient and observer scar assessment scale, and a visual analog scale (VAS). Overall satisfaction with scar cosmesis and surgery was assessed with the VAS. Results: There was no significant difference in the clinical characteristics and operative data between the groups. The objective and subjective scar assessments and the overall satisfaction with scar cosmesis were not different between the groups. In the control group, four (5.7%) women experienced wound discharge and were treated with conservative treatments and delayed closure. In women who completed the first and second assessments, the changes in the scar assessment and overall satisfaction with the scar according to time after surgery were not different in either group, but the patient scar assessment scale in both groups and the VSS in the case group improved. Conclusions: After SP-LS, the approximation of the fascia and subcutaneous layer seems to be enough for the closure of an umbilical incision. Skin closure with subcuticular sutures did not improve the postoperative cosmetic outcomes and might lead to impaired wound healing. However, large randomized trials with various closure techniques and materials are needed to confirm this finding. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Cosmesis Laparoscopy Scar assessment scale Single port surgery
Introduction In various diseases in the gynecologic field, many studies on single port laparoscopic surgery (SP-LS) have been reported [1–3]. SP-LS has some theoretical advantages, including better cosmetic outcome, less postoperative pain, shorter hospital stays, and improved recovery time [4,5]. Of these advantages, the most noticeable benefit of SP-LS might be the cosmetic improvement via a hidden umbilical incision [1,3]. Postoperative scar cosmesis is a critical issue for women, especially young women, because the scars can induce chronic symptoms associated with the wound
* Corresponding author. Tel.: +82 10 6316 7470; fax: +82 2 2007 1466. E-mail address: [email protected] (J.H. Lee). http://dx.doi.org/10.1016/j.ejogrb.2015.03.014 0301-2115/ß 2015 Elsevier Ireland Ltd. All rights reserved.
(such as pain, tenderness, and itching). The negative impact of scars can also have psychological consequences [6,7]. The final appearance and function of postoperative scars are decided by three factors: patient factors, wound factors, and technical factors. Technical factors are completely within the control of the surgeon and are influenced by the closure material and technique of skin apposition [8]. To our knowledge, however, there have been no studies on the standard closure method of umbilical incisions to maximize the cosmetic benefit of SP-LS. Therefore, to provide laparoscopists with evidence-based guidance on the optimal closure method for transumbilical incision, we designed this randomized trial to compare the cosmetic outcome of the umbilical scar according to different closure methods (subcutaneous suture without subcuticular skin suture versus subcutaneous suture with subcuticular skin suture). The primary outcome was to compare the
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
cosmetic outcomes using standardized and validated scar assessment tools, and the secondary outcome was to evaluate the wound complication rate associated with these skin closure methods.
9
diabetes mellitus, severe malnutrition, and diseases requiring chronic corticosteroid use. Operative technique
Materials and methods This prospective randomized study was carried out in women who were scheduled to receive elective SP-LS from August 2012 to March 2013 at Kangbuk Samsung Hospital in Seoul, Republic of Korea. This study was approved by our Institutional Review Board, and all participants provided informed consent. The inclusion criteria were women (age between 18 and 70 years) who had undergone surgery for a benign gynecological disease with a uterus 16 weeks gestational size and/or adnexal mass 8 cm in size, and carcinoma in situ or micro-invasive carcinoma of the uterine cervix. The exclusion criteria included psychiatric disorders, an American Society of Anesthesiologist (ASA) classification above 3, malignant diseases, tattoos and piercing in the umbilicus, history of keloid scarring, previous umbilicus scar, hypersensitivity to the nylon suture material, or medical conditions that could affect wound healing, such as
The port placement system of SP-LS was established as described in our previous reports (Fig. 1) [1–3]. SP-LS was performed using a trans-umbilical GelPoint (Applied Medical, Rancho Santa Margarita, CA, USA) and articulating instruments. After the main operations, the fascia layer of the umbilical incision was approximated by continuous interlocking sutures with 0 absorbable multifilament suture material (Vicryl1, EthiconEthicon Inc., Somerville, NJ), and the subcutaneous layer was approximated by several interrupted sutures with 2-0 absorbable multifilament suture material (Polysorb1, Syneture, Mansfield, MA). The participating patients were randomized to undergo skin closure of their umbilical incision with either subcutaneous suture only without subcuticular skin suture (case group) or both subcutaneous suture and subcuticular skin suture (control group). Only the control group underwent continuous subcuticular suture for skin closure with 3-0 non-absorbable monofilament suture (Nylon1, Woori, Seoul), and the case group did
Fig. 1. (A) Bilateral borders of the umbilicus were clamped and elevated using hemostatic forceps. (B) A 15–20 mm vertical transumbilical skin incision was made by a scalpel. (C) Incision was extended to the peritoneum using a monopolar coagulator. (D) The abdominal wall was lifted using Army–Navy retractors and the incision of the fascia layer was extended caudally and cephalically. (E) The wound retractor of the GelPoint (Applied Medical, Rancho Santa Margarita, CA) was introduced and positioned. (F) The GelPort platform was latched to the retractor.
10
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
not. The closure of skin and subcutaneous layer was performed by three second or third year residents. The wound dressing was carried out daily using povidone-iodine and the non-absorbable sutures were removed on the seventh postoperative day. Scar assessment Scar assessment was carried out at postoperative weeks 5 and 13. The objective scar assessment was performed using the Vancouver Scar scale (VSS) and the observer scar assessment scale (OSAS) of the Patient and Observer Scar Assessment Scale (POSAS) [9,10]. Subjective scar assessment was performed via the patient scar assessment scale (PSAS) of the POSAS and visual analog scale (VAS) [10,11]. The VSS rated four physical characteristics of the scar: vascularity, pigmentation, pliability, and height. Each variable had ranked subscales that could be summed to obtain a total score ranging from 0 to13, where 0 represented normal skin. In the POSAS, each variable used a 10-point scoring system, where 1 represented normal skin. The OSAS of the POSAS rated five variables: vascularity, pigmentation, thickness, relief, and pliability. The rating of individual variables could be summed to obtain a total score ranging from 5 to 50, where 5 represented normal skin. The PSAS of the POSAS includes six domains (pain, itchiness, color, stiffness, thickness, and irregularity). A summary score of 6 corresponds to normal skin, and 60 is the worst scar. All patients were asked to rate their overall satisfaction with the scars and with the surgery using a 10 cm visual analogue scale. Sample size and randomization We calculated the sample size based on a non-inferiority sample size formula with a-error of 0.05, b-error of 0.20, and a noninferiority margin 10 mm on the VAS score, and the minimum sample size was determined to be 37 patients for each arm. Assuming an attrition rate of 40%, at least 124 subjects needed to be randomized. The patients were randomly assigned to either the case or control group by the block randomization method. For participant allocation, a computer-generated list of random numbers was used.
The randomization sequence was generated using Excel 2010 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using block sizes of 4 by an independent doctor. Randomization took place after closure of fascia at operation room using the cards in opaque envelopes labeled consecutively with study numbers. A flowchart of the study participants is provided in Fig. 2. Statistical analysis The data are expressed as the mean standard deviation or median (range). Each variable was confirmed to follow a normal (Gaussian) distribution with the Shapiro–Wilk test. An unpaired t-test was used to compare the parametric variables. A Mann–Whitney U test was used to compare nonparametric variables. A paired T-test was used to compare scores at postoperative months 1 and 3 in each individual. P < 0.05 indicated a significant difference. All analyses were performed using the Statistical Package for Social Sciences (SPSS), version 17.0 for Windows (SPSS Inc., Chicago, IL, USA). Results There were no significant differences in the clinical characteristics and operative data between the groups (Table 1). In the control group, four (5.7%) women experienced discharge from the umbilical wound after the stitches were removed and were treated with conservative treatments or delayed closure without any sequelae. In the case group, single port laparoscopic primary closure was performed in two women with intraoperative bladder laceration. Other complications were resolved by conservative treatments. Table 2 shows a comparison of cosmetic outcomes between the groups. With respect to the objective and subjective scar assessments and the overall satisfaction for scar cosmesis and surgery, there were no differences between the groups. In women that completed the first and second scar assessments, the changes in scar assessment results, overall satisfaction with the scar (VAS for scar), and the overall satisfaction with the surgery (VAS for surgery) according to the time interval were not different
Fig. 2. Flowchart detailing the study participants. Case group = women underwent skin closure with only subcutaneous suture; control group = women underwent skin closure with a subcutaneous and subcuticular suture.
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
11
Table 1 Clinical characteristics and operative data. Mean SD/number (%)/mean (range)
Characteristics
Number of patients Age of patients (years) Body mass index (kg/m2) Parity Number of patients with previous abdominal surgery
P value
Case group
Total 134 40.98 8.97 22.88 3.52 1.1 (0–3) 47 (34.1)
Control group
68 41.80 8.59 22.64 3.61 1.2 (0–3) 21 (30.9)
70 40.17 9.30 23.10 3.44 1.0 (0–3) 26 (37.1)
33 7 15 10 3
31 3 18 13 5
0.29a 0.45a 0.49a 0.44b 0.59b
Surgery performed LAVH LAVH with adnexal surgery Adnexal surgery LM LM with adnexal surgery
64 10 32 23 8
Operating time (min)
(47.0) (7.2) (23.2) (16.7) (5.8)
118 (65–265)
Hospital stay
118 (65–265)
3.30 (1–12)
Complication Intraoperative complications Bladder injury Postoperative complications Transfusion Postoperative fever Ileus Wound complication
(48.5) (10.3) (22.1) (14.7) (4.4)
3.22 (1–6)
26 (21.7)
13 (19.1)
2 (1.4)
2 (2.9)
19 4 1 4
(13.8) (2.9) (0.7) (2.9)
(44.3) (4.3) (25.7) (18.6) (7.1)
117 (75–190)
0.85a
3.38 (3–12)
0.33a
17 (24.3)
0.94b
0 (0)
9 (13.2) 2 (2.9) 0 0
10 2 1 4
(14.3) (2.9) (1.4) (5.7)
Case group = women underwent skin closure with only Subcutaneous Suture; control group = women underwent skin closure with subcutaneous and subcuticular suture. a According to an unpaired t test. b According to a Pearson x2 test.
in each group, but the PSAS scores in both groups and the VSS scores in the case group improved at the second assessment (at postoperative week 13) compared to the initial assessment (at postoperative week 5) (Table 3). The results of this study were reported according to the ontreatment analysis. Comment Because concern about postoperative cosmetic outcomes has been increasing, many studies have been published on various methods of skin closure after surgery [12–14]. Recently, SP-LS has been performed in various surgical fields, and many studies have reported its safety, feasibility, and efficacy [2,3,8,15,16]. However, there have been no studies on skin closure methods following SP-LS, despite the anatomical and physical characteristics of the umbilicus. Studies have reported that, compared with conventional laparoscopic surgery, SP-LS decreases postoperative pain and improves cosmetic outcome [1,8,15,16]. The results of this study, the first report on skin closure methods in SP-LS, showed that skin closure using a subcuticular suture does not improve the cosmetic
outcome of the umbilical incision compared with not performing it. A subcuticular suture might cause wound complications, though our results for this complication were not statistically significant. The approximation of the fascia and subcutaneous layer appears to be sufficient for the closure of an umbilical incision. These findings are attributable the anatomical and physical characteristics of the umbilicus. Hypertrophic scars are known to occur at sites that are highly mobile and under high tension, such as the anterior chest, suprapubic region, and upper arm, whereas the umbilicus is immobile and is influenced by weak mechanical forces [17]. Furthermore, if the umbilical stalk is properly reattached to the fascia with an anchoring suture, the apposition of the edges of the incision can be ensured. Due to a natural deep dimple of the umbilicus, a subcuticular skin suture is technically difficult and time consuming. Thus, the increased wound complication rate in the control group could be due to impaired wound healing caused by excessive tissue manipulation for a relatively long period of time. The final cosmesis of the wounds was assessed at 3 months. We previously reported a comparative cross-sectional study on cosmetic outcomes after single port or conventional laparoscopic surgery; the mean interval from operation to scar assessment was
Table 2 Scar assessment results. Variable
Number of patients VSS POSAS OSAS PSAS VAS for scar cosmesis VAS for surgery
5 Weeks postoperatively
P value
Cohen’s d (95% CI)
13 Weeks postoperatively
P value
Cohen’s d (95% CI)
Case group
Control group
Case group
Control group
68
66
49
38
4.54 2.24 15.75 7.43 14.66 7.82 8.77 1.80
4.04 2.31 14.16 7.18 17.31 9.94 8.80 1.48
0.21 0.21 0.89 0.93
0.22 ( 0.12, 0.56) 0.22 ( 0.13, 0.56) 0.3 ( 0.64, 0.05) 0.02 ( 0.36, 0.32)
3.98 2.56 14.14 8.22 12.38 7.85 9.00 1.62
3.44 2.32 12.47 7.21 13.18 7.92 9.09 1.25
0.32 0.33 0.64 0.76
0.22 ( 0.21, 0.65) 0.21 ( 0.22, 0.65) 0.1 ( 0.53, 0.33) 0.06 ( 0.49, 0.37)
8.30 2.14
8.37 1.85
0.85
0.03 ( 0.38, 0.31)
8.48 2.04
8.43 2.06
0.92
0.02 ( 0.41, 0.45)
Case group = women underwent skin closure with only subcutaneous suture; control group = women underwent skin closure with subcutaneous and subcuticular suture; CI = Confidence Interval; OSAS = observer scar assessment scale; POSAS = patient and observer scar assessment scale; PSAS = patient scar assessment scale; VAS for scar cosmesis = visual analog scale represents patients’ overall satisfaction with scar cosmesis; VAS for surgery = visual analog scale represents patients’ overall satisfaction with surgery; VSS = Vancouver Scar Scale. According to an unpaired t test.
12
S.Y. Park et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 189 (2015) 8–12
Table 3 Change in assessment results according to time interval after surgery. Variable
Number of patients VSS POSAS OSAS PSAS VAS for scar cosmesis VAS for surgery
Case group
P value
Cohen’s d (95% CI)
Control group
P value
5 Weeks postoperatively
13 Weeks postoperatively
5 Weeks postoperatively
13 Weeks postoperatively
49
49
38
38
4.49 2.29 15.59 7.57 15.00 8.19 8.63 1.99
3.98 2.56 14.14 8.22 12.38 7.85 9.00 1.62
0.30 0.31 < 0.01 0.07
0.21 ( 0.19, 0.61) 0.18 ( 0.22, 0.59) 0.33 ( 0.08, 0.73) 0.2 ( 0.61, 0.2)
4.63 2.29 14.94 6.68 16.97 11.18 8.81 1.80
3.44 2.32 12.47 7.21 13.18 7.92 9.09 1.25
< 0.01 0.09 0.04 0.13
8.21 2.28
8.48 2.04
0.12
0.12 ( 0.53, 0.28)
8.28 2.11
8.43 2.06
0.58
Cohen’s d (95% CI)
0.52 0.36 0.39 0.18
(0.05, 0.98) ( 0.11, 0.82) ( 0.07, 0.85) ( 0.64, 0.28)
0.07 ( 0.53, 0.39)
Data are expressed as the mean standard deviation. Case group = women underwent skin closure with only subcutaneous suture; control group = women underwent skin closure with subcutaneous and subcuticular suture; CI = Confidence Interval; OSAS = observer scar assessment scale; POSAS = patient and observer scar assessment scale; PSAS = patient scar assessment scale; VAS for scar cosmesis = visual analog scale represents patients’ overall satisfaction with scar cosmesis; VAS for surgery = visual analog scale represents patients’ overall satisfaction with surgery; VSS = vancouver scar scale. According to a paired t test.
64.8 weeks (range, 26.7 to 144 weeks), and the scar was evaluated with the same tools that were used in the current study [1]. Comparing the scores from the assessment tools at postoperative week 15 in the current study and those in our previous report, there were no statistically significant differences. Based on this result, although scar maturation continues to 52 weeks after surgery [18], we believe that the follow-up time of our study is acceptable. In addition, scar assessment and patient satisfaction with the scar and surgery did not significantly improve over time, as shown in Table 3. Considering the results of our previous study with a relatively long follow-up, it can be assumed that there would be no significant difference between the groups if further observations were conducted. However, the PSAS scores in both groups improved during the time interval. This result is thought to be because the PSAS of the POSAS includes two domains (pain and itchiness) that improved unlike other domains of the POSAS. The current study has potential limitations. First, there were variations in the surgeons’ closure techniques and inter-observer bias because three physicians performed the closure of and evaluation of the umbilical wounds. Second, we used only one type of device (trans-umbilical GelPort). Therefore, the effects of the device for SP-LS on wound scarring were not considered. Third, we did not assess other skin closure techniques, such as stables or skin adhesives. Although skin adhesives are costly, we believe that they should be a choice for umbilical wound closure in SP-LS because they can be applied quickly, patients may shower during the immediate postoperative period, they need not to be removed, and umbilical wounds have irregular margins [14]. Lastly, an evaluation of whether the subcutaneous suture could also be omitted was not performed. In conclusion, this study shows that in SP-LS, the ideal closure method of an umbilical incision includes approximation of the fascia and subcutaneous layer, and skin closure using subcuticular sutures might be redundant, leading to impaired wound healing. However, large randomized trials with various techniques and materials are needed to confirm this result. Conflict of interest statement This article was not supported by any financial funds and not affiliated with the instrument company referred to in the text. Condensation After single port laparoscopy, the approximation of the fascia and subcutaneous layer without skin suture seems to be enough for the closure of umbilical incision.
References
[1] Eom J.M., Ko J.H., Choi J.S., Hong J.H., Lee J.H.. A comparative cross-sectional study on cosmetic outcomes after single port or conventional laparoscopic surgery. Eur J Obstet Gynecol Reprod Biol 2013;167:104–9. [2] Lee J.H., Choi J.S., Jeon S.W., Son C.E., Hong J.H., Bae J.W.. A prospective comparison of single-port laparoscopically assisted vaginal hysterectomy using transumbilical GelPort access and multiport laparoscopically assisted vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol 2011;158:294–7. [3] Lee J.H., Choi J.S., Jeon S.W., Son C.E., Lee S.J., Lee Y.S.. Single-port laparoscopic myomectomy using transumbilical GelPort access. Eur J Obstet Gynecol Reprod Biol 2010;153:81–4. [4] Garg P., Thakur J.D., Raina N.C., Mittal G., Garg M., Gupta V.. Comparison of cosmetic outcome between single-incision laparoscopic cholecystectomy and conventional laparoscopic cholecystectomy: an objective study. J Laparoendosc Adv Surg Tech A 2012;22:127–30. [5] Santos B.F., Reif T.J., Soper N.J., Hungness E.S.. Effect of training and instrument type on performance in single-incision laparoscopy: results of a randomized comparison using a surgical simulator. Surg Endosc 2011;25:3798–804. [6] Vercelli S., Ferriero G., Sartorio F., Stissi V., Franchignoni F.. How to assess postsurgical scars: a review of outcome measures. Disabil Rehabil 2009;31: 2055–63. [7] Gangl O., Hofer W., Tomaselli F., Sautner T., Fugger R.. Single incision laparoscopic cholecystectomy (SILC) versus laparoscopic cholecystectomy (LC)-a matched pair analysis. Langenbecks Arch Surg 2011;396:819–24. [8] Kim T.J., Lee Y.Y., Cha H.H., et al. Single-port-access laparoscopic-assisted vaginal hysterectomy versus conventional laparoscopic-assisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc 2010;24: 2248–52. [9] Baryza M.J., Baryza G.A.. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil 1995;16:535–8. [10] Draaijers L.J., Tempelman F.R., Botman Y.A., et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg 2004;113:1960–5 (discussion 6–7). [11] Duncan J.A., Bond J.S., Mason T., et al. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg 2006;118:909–18. [12] Cromi A., Ghezzi F., Gottardi A., Cherubino M., Uccella S., Valdatta L.. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol 2010;203. 36 e1-36 e8. [13] Dowson C.C., Gilliam A.D., Speake W.J., Lobo D.N., Beckingham I.J.. A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures. Surg Laparosc Endosc Percutan Tech 2006;16:146–50. [14] Yang Y.L., Xiang Y.Y., Jin L.P., et al. Closure of skin incision after thyroidectomy through a supraclavicular approach: a comparison between tissue adhesive and staples. Scand J Surg 2013;102:234–40. [15] Chen Y.J., Wang P.H., Ocampo E.J., Twu N.F., Yen M.S., Chao K.C.. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol 2011;117:906–12. [16] Jung Y.W., Lee M., Yim G.W., et al. A randomized prospective study of singleport and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc 2011;25:2462–9. [17] Ogawa R., Mitsuhashi K., Hyakusoku H., Miyashita T.. Postoperative electronbeam irradiation therapy for keloids and hypertrophic scars: retrospective study of 147 cases followed for more than 18 months. Plast Reconstr Surg 2003;111:547–53 (discussion 54–55). [18] Brown N.J., Smyth E.A., Cross S.S., Reed M.W.. Angiogenesis induction and regression in human surgical wounds. Wound Repair Regen 2002;10:245–51.
