Surg Endosc DOI 10.1007/s00464-014-3873-3
and Other Interventional Techniques
Transvaginal cholecystectomy learning curve Stephanie G. Wood • Feng Dai • Susan Dabu-Bondoc Hosni Mikhael • Nalini Vadivelu • Andrew Duffy • Kurt E. Roberts
•
Received: 22 April 2014 / Accepted: 4 September 2014 Ó Springer Science+Business Media New York 2014
Abstract Background There are few surgeons in the United States, within private practice and academic centers, currently performing transvaginal cholecystectomies (TVC). The lack of exposure to TVC during residency or fellowship training, coupled with a poorly defined learning curve, further limits interested surgeons who want to apply this technique to their practice. This study describes the learning curve encountered during the introduction of TVC to our academic facility. Methods This study is an analysis of consecutive TVCs performed between August 14, 2009 and August 3, 2012 at an academic center. The TVC patients were divided into Electronic supplementary material The online version of this article (doi:10.1007/s00464-014-3873-3) contains supplementary material, which is available to authorized users. S. G. Wood (&) A. Duffy K. E. Roberts (&) Department of Surgery, Yale School of Medicine, 40 Temple St., Suite 7B, New Haven, CT 06510, USA e-mail: [email protected]
sequential quartiles (n = 15/16). The learning curve outcome was measured as the operative time of TVC patients and compared to the operative time of female laparoscopic cholecystectomy (LC) patients performed during the same time period. Results Sixty-one patients underwent a TVC with a mean age of 38 ± 12 years and mean BMI was 29 ± 6 kg/m2. Sixty-seven female patients who underwent a LC with average age 41 ± 15 years and average BMI 33 ± 12 kg/ m2. The average operative time of LC patients and TVC patients was 48 ± 20 and 60 ± 17 min, respectively. Significant improvement in TVC operative times was seen between the first (n = 15 TVCs) and second quartiles (p = 0.04) and stayed relatively constant for third quartile, during which there was no statistically significant difference between the mean LC operative time for the second and third TVC quartiles Conclusions The learning curve of a fellowship-trained surgeon introducing TVC to their surgical repertoire, as measured by improved operative times, can be achieved with approximately 15 cases.
K. E. Roberts e-mail: [email protected] A. Duffy e-mail: [email protected] F. Dai S. Dabu-Bondoc H. Mikhael N. Vadivelu Department of Anesthesiology, Yale School of Medicine, 333 Cedar Street, TMP 3, New Haven, CT 06520, USA e-mail: [email protected] S. Dabu-Bondoc e-mail: [email protected] H. Mikhael e-mail: [email protected] N. Vadivelu e-mail: [email protected]
Keywords Transvaginal NOTES Learning curve Cholecystectomy Despite growing evidence verifying the safety and efficacy of the transvaginal cholecystectomy (TVC), this emerging frontier is met with a critical view from the surgical community. Recent clinical trials by the German [1] and the international multicenter trial on NOTES [2] registries present transvaginal cholecystectomies (TVC) as a practical and safe alternative to laparoscopic cholecystectomies for women. Compared to laparoscopic cholecystectomy, the TVC approach has demonstrated benefits of improved
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cosmesis and faster recovery, decreased postoperative pain, wound infections, and incisional hernias [1–5]. Low acceptance for transvaginal NOTES from the surgical community in the United States is illustrated by the fact that few surgeons within private practice and academic centers are currently performing TVC [6–10]. The lack of exposure to TVC during residency or fellowship training, coupled with a poorly defined learning curve, further limits interested surgeons who want to apply this technique to their practice. This study describes the learning curve encountered during the introduction of TVC to our academic facility.
Methods This is an analysis of consecutive TVC and laparoscopic cholecystectomy (LC) procedures performed between August 8, 2009 and August 30, 2012 by a single surgeon (KER), at an academic center, from electronically recorded operative records. This study protocol was Institutional Review Board (IRB) approved. This study period reflects the time in which there was an active IRB for recruitment of TVC patients into other protocols. In contrast to the TVC group, which were enrolled prospectively within separate studies, the LC group was identified retrospectively during the same time period. Female patients aged 18–70 years old who received an elective TVC or LC were included. The preoperative diagnoses for the TVC group included biliary dyskinesia and symptomatic cholelithiasis. The inclusion criteria in the LC group were less specific, and may include cholecystitis. Some of the LC patients may have been offered, and declined, TVC; however, the data does not differentiate between those who were offered and not offered TVC. The exclusion criteria for TVC patients only were defined as follows: pregnancy; BMI [ 45 kg/m2; undergoing peritoneal dialysis; on immunosuppressive medication or immunocompromised; on therapeutic anticoagulation or anti-platelet therapies or abnormal pre-operative coagulation studies; prior transvaginal surgery; history of pelvic inflammatory disease or suspected severe endometriosis or inability to understand English. Informed consent was obtained for all patients prior to surgery by the operating surgeon in the clinic setting. The learning curve of TVC was measured as the operative time of TVC over the time course of the study. The operative times of LC patients performed during the same time period were also recorded as a baseline (control) of the surgeon (KER) performing the operations. Complications were described for the TVC group only and classified according to Dindo et al. [11], with Grades I and II were considered minor complications and grades III–IV were considered major
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complications. The LC group complication data were not available within the operative records used in study. The TVC operative technique has been previously described in details elsewhere [4, 12]. In brief, all operations were hybrid TVC with access to the peritoneal cavity initially obtained by placement of a transumbilical 5 mm trocar, followed by placement of a transvaginal 12 mm port under direct laparoscopic visualization. Only standard straight laparoscopic instruments for dissection and specimen retrieval were used. The surgeon had performed 7 transvaginal appendectomies (TVA) prior to the introduction of the TVC to practice. A gynecologist performed the TV access and closure for the initial 5 TVA cases and observed the surgeon (KER) for 15 cases (TVA and TVC) before the surgeon performed the TV procedures independently. The LC patients underwent a standard 4 port LC which has been previously described [4]. A surgical fellow assisted during the TVC, however, which parts of the procedure performed by the attending surgeon or fellow were not differentiated in this study. The operative (OR) time was presented as mean ± SD. The average operative time of TVC at each of four learning periods was compared to the average time for all laparoscopic cholecystectomy (LC) cases during the 3-year period using a one-way ANOVA method, and followed by post hoc pairwise comparisons if there was a significant omnibus F test. All the statistical analyses were conducted using SAS software, version 9.2 (Cary, NC). A two-sided p value of less than 0.05 was considered to indicate statistical significance.
Results Sixty-one female patients underwent a TVC. The average age was 38 ± 12 years and average BMI was 29 ± 6 kg/m2. For comparison, we included 67 female patients who underwent a LC during the same 3-year period (Fig. 1). The average age of LC patients was 41 ± 15 years and average BMI was 33 ± 12 kg/m2. The mean operative (OR) time for TVC was 60 ± 17 min (range 31–94 min). There was no statistically significant difference in OR times between obese (BMI [ 30) and non-obese patients (p = 0.20). As previously described, there were 1 major and 3 minor complications, and 1 conversion to conventional LC (after transvaginal access) [7]. The TVC patients were divided into sequential quartiles (n = 15/ 16), shown in Fig. 1. There was no significant difference in age and BMI between the TVC and LC quartile groups (p = 0.12). And there was no statistically significant difference in age (p = 0.11) and BMI (p = 0.14) between TVC patients in all the four quartiles. The mean TVC operative times for the quartiles were 67 ± 14, 55 ± 19, 56 ± 17, and 64 ± 17 min, respectively. The average OR time of LC was 48 ± 20 min (range 25–136 min), which was significantly lower than that of TVC at first quartile (i.e., starting period)
Surg Endosc p = 0.005
100 p = 0.256
90
p = 0.001
OR time (Minutes)
80
p = 0.584 p = 0.066
p = 0.094
70
Lap Chole TVC: First Quartile TVC: Second Quartile TVC: Third Quartile TVC: Fourth Quartile
60 50 40 30 20 10
rt ile
rt ile rt h
Q ua
Q ua TV C :F ou
rt ile Q ua
TV C :T hi rd
TV C :S ec on d
le C ho La p
TV C :F irs
tQ ua rt ile
0
Fig. 1 Analysis of transvaginal cholecystectomy (TVC) learning curve. TVC patients were divided into sequential quartiles (n = 15/16). Lap chole mean laparoscopic cholecystectomy operative time during the same overall time period
(p = 0.001) and fourth quartile (p = 0.005). No significant differences of OR time were identified between LC and other (i.e., second and third) TVC quartile groups. The average TVC OR time decreased in the second quartile, compared to the first quartile, and stayed relatively constant for third quartile, and then slightly increased in the fourth quartile. However, there was no statistically significant difference among the four TVC quartiles. (Fig. 1) Two additional analyses (Supplemental Fig. 1a, b) were performed whereby the 61 TVC patients were split into sextiles (i.e., groups of 10), and tertiles (i.e., groups of 20), respectively. As shown in Supplemental Fig. 1a, a statistically significant difference was noted when LC operating times compared to the first and second sextile TVC patients (p = 0.001, p = 0.035, respectively). This suggests the learning curve was not peaking after 10 cases. When TVC patients were split into tertiles (Supplemental Fig. 1b), the mean operating times were statistically significant between the LC patients and first tertile of TVC patients (p = 0.001), but not with second tertile (p = 0.157), a trend that was consistent to what were identified when we compared LC patients with TVC quartile groups (Fig. 1). Therefore, these results suggest our conclusion that the learning curve was approximately 15 cases. Two minor complications (IUD dislodgement and urinary retention) occurred in the first quartile. One minor (temporary brachial plexus injury) and 1 major (omental bleed) occurred in the second quartile. The one conversion, after TV access, occurred in the third quartile.
Discussion Minimally invasive laparoscopic surgery has rapidly become the new gold standard for many surgical procedures.
This frontier is continuously forged with new applications of minimally invasive techniques such as single incision (multi-port) laparoscopic surgery (SILS), robotic surgery, and NOTES, which aim to decrease surgical trauma and improve outcomes for the patient. Strides have been made toward the goal of ‘‘scarless’’ surgery, particularly in transvaginal NOTES surgery. Specifically, the hybrid TVC has several advantages other than cosmesis, including faster recovery, decreased pain, and decreased risk of incisional hernia complications [13]. The TVC merges traditional laparoscopic instruments and techniques with the long established transvaginal access approach of gynecologists. Over 1163 TVCs have been reported by international registries and prospective trials of TVCs to date, including Euro-NOTES (n = 435), International Prospective Multicenter Trial on Clinical NOTES (n = 240) and German NOTES registry (n = 488), demonstrating the safety and efficacy of TVC when performed by trained surgeons [1, 2, 14]. Despite growing interest in this procedure, the expected learning curve for a surgeon to introduce the technique to their surgical acumen is poorly defined. Improvement in efficiency of specific surgical technique is difficult to measure in vivo. As such, the use of operative time, though imperfect, has commonly been used as a measure of surgical learning curve in the literature [15–18]. The learning curve of a fellowship-trained minimally invasive surgeon introducing TVC to clinical practice in this study, as measured by improved operative times, was approximately 15 cases. The overall mean operative time for the TVC patients, 60.3 min, was consistent with several previous studies [19–23]. A significant improvement in operative time was noted after the first quartile, and remained comparable to the overall LC operative time during the second and third quartiles. The introduction of a new surgical fellow in the fourth quartile, who was learning the procedure under guidance from the initial surgeon, may have contributed to the increase in operative times seen. However, this study did not differentiate between the fellow and attending surgeon, with different parts of the surgery performed by either person. The short learning curve seen in this study was consistent with two other recent studies [19, 24]. Bulian et al. demonstrated shorter operative times with an increase in TVC procedures performed, with a mean operative time of 82.3 min in the first 25 cases and 73.3 min in the second 25 cases [24]. Van den Boezem et al., similarly, noted that TVC operating time decreased from 90 min to approximately 55 min after only 10 procedures [19]. A different study, Federlein et al., suggests that the learning curve may be shorter for more experienced surgeons, showing a significant decrease in TVC operative times performed by surgeons with [500 LC experience compared to less experienced surgeons [23].
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The lack of TVC complications reported in the third and fourth quartile in this study supports that with increased experience the risk of complication decreases. The introduction of a new surgical fellow did not appear to have a detrimental effect on patient complications. This emphasizes the benefit of introducing the TVC technique under supervision of a surgeon who is familiar with this operative approach, knowledgeable in the potential pitfalls and problems. The learning curve of 15 cases seen in our study may be even less today than when the study was started in 2009, since the technique is now well established and well described in the literature. Skills learned to perform single incision laparoscopic surgery are similarly applied in the hybrid TVC such as adapting to limited triangulation and performing dissection of the gallbladder through a single transumbilical port. However, the single 5 mm port used in a TVC is less traumatic than a SILS procedure, and therefore less likely to have an incisional hernia complication. In contrast to the SILS approach, the specimen extraction technique used in the TVC approach, through the colpotomy incision, avoids further injury to the abdominal wall fascia. Nonetheless, the SILS cholecystectomy may lessen the learning curve of a surgeon who is introducing the TVC to practice. The established skill-set for SILS cholecystectomy, which boasts a short learning curve of approximately 10 cases [17], may be adapted to the hybrid TVC using standard straight laparoscopic instruments. This step-wise introduction of the TVC, with the preceding introduction of SILS cholecystectomy to practice, likely contributed to the relative short learning curve seen in this study. The largest difference between a LC or SILS and the TVC is, of course, the transvaginal colpotomy access and closure, which is not a technique that is typically learned as a general or minimally invasive surgeon. This obstacle is surmounted with initial assistance and supervision by a gynecologist as well as an understanding of specific vaginal landmarks in the posterior fornix, from transvaginal view, and pelvic cul de sac, from the transumbilical view [25]. The optimal technique is critical to avoid injury of surrounding structures occurred during access; specifically, direct transumbilical visualization for TV access, recognizing the appropriate landmarks within the posterior fornix, and angling of the transvaginal trocar anteriorly toward the umbilicus during placement are essential to avoid injury to surrounding structures. Additionally, closure of the colpotomy at the completion of the TVC is performed transvaginally with a running absorbable suture should be directly visualized from the transumbilical port in order to confirm adequate and safe closure. In conclusion, the learning curve of a fellowship-trained surgeon introducing TVC to their surgical repertoire, as measured by improved operative times, can be achieved
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with approximately 15 cases. As with any new procedure, the greater procedure time initially required to perform a TVC should be weighed against the possible postoperative benefits and risks. Acknowledgments This publication was made possible by CTSA Grant Number UL1 RR024139, from the National Center for Research Resources (NCRR) and the National Center for Advancing Translational Science (NCATS), components of the National Institutes of Health (NIH), and NIH roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH. Disclosures Wood, Dai, Dabu-Bondoc, Mikhael, Vadivelu, and Duffy have no conflicts of interest or financial ties to disclose. Dr. Roberts provided consultancy services for Covidien, participated in a Covidien-sponsored grant, and has a patent pending with NovaTract.
References 1. Lehmann KS, Ritz JP, Wibmer A, Gellert K, Zornig C, Burghardt J, Busing M, Runkel N, Kohlhaw K, Albrecht R, Kirchner TG, Arlt G, Mall JW, Butters M, Bulian DR, Bretschneider J, Holmer C, Buhr HJ (2010) The German registry for natural orifice translumenal endoscopic surgery: report of the first 551 patients. Ann Surg 252:263–270 2. Zorron R, Palanivelu C, Galvao Neto MP, Ramos A, Salinas G, Burghardt J, DeCarli L, Henrique Sousa L, Forgione A, Pugliese R, Branco AJ, Balashanmugan TS, Boza C, Corcione F, D’Avila Avila F, Arturo Gomez N, Galvao Ribeiro PA, Martins S, Filgueiras M, Gellert K, Wood Branco A, Kondo W, Inacio Sanseverino J, de Sousa JA, Saavedra L, Ramirez E, Campos J, Sivakumar K, Rajan PS, Jategaonkar PA, Ranagrajan M, Parthasarathi R, Senthilnathan P, Prasad M, Cuccurullo D, Muller V (2010) International multicenter trial on clinical natural orifice surgery–NOTES IMTN study: preliminary results of 362 patients. Surg Innov 17:142–158 3. Hensel M, Schernikau U, Schmidt A, Arlt G (2011) Surgical outcome and midterm follow-up after transvaginal NOTES hybrid cholecystectomy: analysis of a prospective clinical series. J Laparoendosc Adv Surg Tech A 21:101–106 4. Solomon D, Shariff AH, Silasi DA, Duffy AJ, Bell RL, Roberts KE (2012) Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc 26: 2823–2827 5. Auyang ED, Santos BF, Enter DH, Hungness ES, Soper NJ (2011) Natural orifice translumenal endoscopic surgery (NOTES((R))): a technical review. Surg Endosc 25:3135–3148 6. Nijhawan S, Barajas-Gamboa JS, Majid S, Jacobsen GR, Sedrak MF, Sandler BJ, Talamini MA, Horgan S (2013) NOTES transvaginal hybrid cholecystectomy: the United States human experience. Surg Endosc 27:514–517 7. Wood SG, Panait L, Duffy AJ, Bell RL, Roberts KE (2013) Complications of transvaginal natural orifice transluminal endoscopic surgery: a series of 102 patients. Ann Surg 259:744–749 8. Santos BF, Teitelbaum EN, Arafat FO, Milad MP, Soper NJ, Hungness ES (2012) Comparison of short-term outcomes between transvaginal hybrid NOTES cholecystectomy and laparoscopic cholecystectomy. Surg Endosc 26:3058–3066 9. Gumbs AA, Fowler D, Milone L, Evanko JC, Ude AO, Stevens P, Bessler M (2009) Transvaginal natural orifice translumenal
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endoscopic surgery cholecystectomy: early evolution of the technique. Ann Surg 249:908–912 Bessler M, Stevens PD, Milone L, Parikh M, Fowler D (2007) Transvaginal laparoscopically assisted endoscopic cholecystectomy: a hybrid approach to natural orifice surgery. Gastrointest Endosc 66:1243–1245 Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213 Roberts KE, Shetty S, Shariff AH, Silasi DA, Duffy AJ, Bell RL (2012) Transvaginal NOTES hybrid cholecystectomy. Surg Innov 19:230–235 Bulian DR, Trump L, Knuth J, Cerasani N, Heiss MM (2013) Longterm results of transvaginal/transumbilical versus classical laparoscopic cholecystectomy-an analysis of 88 patients. Langenbecks Arch Surg 398:571–579 Arezzo A, Zornig C, Mofid H, Fuchs KH, Breithaupt W, Noguera J, Kaehler G, Magdeburg R, Perretta S, Dallemagne B, Marescaux J, Copaescu C, Graur F, Szasz A, Forgione A, Pugliese R, Buess G, Bhattacharjee HK, Navarra G, Godina M, Shishin K, Morino M (2013) The EURO-NOTES clinical registry for natural orifice transluminal endoscopic surgery: a 2-year activity report. Surg Endosc 27:3073–3084 van den Boezem PB, Kruyt PM, Cuesta MA, Sietses C (2012) Single-incision versus conventional laparoscopic cholecystectomy: a case control study. Acta Chir Belg 112:374–377 Feinberg EJ, Agaba E, Feinberg ML, Camacho D, Vemulapalli P (2012) Single-incision laparoscopic cholecystectomy learning curve experience seen in a single institution. Surg Laparosc Endosc Percutan Tech 22:114–117 Solomon D, Bell RL, Duffy AJ, Roberts KE (2010) Single-port cholecystectomy: small scar, short learning curve. Surg Endosc 24:2954–2957
18. Osborne AJ, Clancy R, Clark GW, Wong C (2013) Single incision laparoscopic adjustable gastric band: technique, feasibility, safety and learning curve. Ann R Coll Surg Engl 95:131–133 19. van den Boezem PB, Velthuis S, Lourens HJ, Samlal RA, Cuesta MA, Sietses C (2013) Hybrid transvaginal cholecystectomy, clinical results and patient-reported outcomes of 50 consecutive cases. J Gastrointest Surg 17:907–912 20. Brescia A, Masoni L, Gasparrini M, Nigri G, Cosenza UM, Dall’Oglio A, Pancaldi A, Mari FS (2013) Laparoscopic assisted transvaginal cholecystectomy: single centre preliminary experience. Surgeon 11(Suppl 1):S1–S5 21. Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC (2012) Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc 26:3435–3441 22. Linke GR, Tarantino I, Bruderer T, Celeiro J, Warschkow R, Tarr PE, Muller-Stich BP, Zerz A (2012) Transvaginal access for NOTES: a cohort study of microbiological colonization and contamination. Endoscopy 44:684–689 23. Federlein M, Borchert D, Muller V, Atas Y, Fritze F, Burghardt J, Elling D, Gellert K (2010) Transvaginal video-assisted cholecystectomy in clinical practice. Surg Endosc 24:2444–2452 24. Bulian DR, Trump L, Knuth J, Siegel R, Sauerwald A, Strohlein MA, Heiss MM (2013) Less pain after transvaginal/transumbilical cholecystectomy than after the classical laparoscopic technique: short-term results of a matched-cohort study. Surg Endosc 27:580–586 25. Roberts K, Solomon D, Bell R, Duffy A (2013) ‘‘Triangle of safety’’: anatomic considerations in transvaginal natural orifice surgery. Surg Endosc 27:2963–2965
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and Other Interventional Techniques
Transvaginal cholecystectomy learning curve Stephanie G. Wood • Feng Dai • Susan Dabu-Bondoc Hosni Mikhael • Nalini Vadivelu • Andrew Duffy • Kurt E. Roberts
•
Received: 22 April 2014 / Accepted: 4 September 2014 Ó Springer Science+Business Media New York 2014
Abstract Background There are few surgeons in the United States, within private practice and academic centers, currently performing transvaginal cholecystectomies (TVC). The lack of exposure to TVC during residency or fellowship training, coupled with a poorly defined learning curve, further limits interested surgeons who want to apply this technique to their practice. This study describes the learning curve encountered during the introduction of TVC to our academic facility. Methods This study is an analysis of consecutive TVCs performed between August 14, 2009 and August 3, 2012 at an academic center. The TVC patients were divided into Electronic supplementary material The online version of this article (doi:10.1007/s00464-014-3873-3) contains supplementary material, which is available to authorized users. S. G. Wood (&) A. Duffy K. E. Roberts (&) Department of Surgery, Yale School of Medicine, 40 Temple St., Suite 7B, New Haven, CT 06510, USA e-mail: [email protected]
sequential quartiles (n = 15/16). The learning curve outcome was measured as the operative time of TVC patients and compared to the operative time of female laparoscopic cholecystectomy (LC) patients performed during the same time period. Results Sixty-one patients underwent a TVC with a mean age of 38 ± 12 years and mean BMI was 29 ± 6 kg/m2. Sixty-seven female patients who underwent a LC with average age 41 ± 15 years and average BMI 33 ± 12 kg/ m2. The average operative time of LC patients and TVC patients was 48 ± 20 and 60 ± 17 min, respectively. Significant improvement in TVC operative times was seen between the first (n = 15 TVCs) and second quartiles (p = 0.04) and stayed relatively constant for third quartile, during which there was no statistically significant difference between the mean LC operative time for the second and third TVC quartiles Conclusions The learning curve of a fellowship-trained surgeon introducing TVC to their surgical repertoire, as measured by improved operative times, can be achieved with approximately 15 cases.
K. E. Roberts e-mail: [email protected] A. Duffy e-mail: [email protected] F. Dai S. Dabu-Bondoc H. Mikhael N. Vadivelu Department of Anesthesiology, Yale School of Medicine, 333 Cedar Street, TMP 3, New Haven, CT 06520, USA e-mail: [email protected] S. Dabu-Bondoc e-mail: [email protected] H. Mikhael e-mail: [email protected] N. Vadivelu e-mail: [email protected]
Keywords Transvaginal NOTES Learning curve Cholecystectomy Despite growing evidence verifying the safety and efficacy of the transvaginal cholecystectomy (TVC), this emerging frontier is met with a critical view from the surgical community. Recent clinical trials by the German [1] and the international multicenter trial on NOTES [2] registries present transvaginal cholecystectomies (TVC) as a practical and safe alternative to laparoscopic cholecystectomies for women. Compared to laparoscopic cholecystectomy, the TVC approach has demonstrated benefits of improved
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cosmesis and faster recovery, decreased postoperative pain, wound infections, and incisional hernias [1–5]. Low acceptance for transvaginal NOTES from the surgical community in the United States is illustrated by the fact that few surgeons within private practice and academic centers are currently performing TVC [6–10]. The lack of exposure to TVC during residency or fellowship training, coupled with a poorly defined learning curve, further limits interested surgeons who want to apply this technique to their practice. This study describes the learning curve encountered during the introduction of TVC to our academic facility.
Methods This is an analysis of consecutive TVC and laparoscopic cholecystectomy (LC) procedures performed between August 8, 2009 and August 30, 2012 by a single surgeon (KER), at an academic center, from electronically recorded operative records. This study protocol was Institutional Review Board (IRB) approved. This study period reflects the time in which there was an active IRB for recruitment of TVC patients into other protocols. In contrast to the TVC group, which were enrolled prospectively within separate studies, the LC group was identified retrospectively during the same time period. Female patients aged 18–70 years old who received an elective TVC or LC were included. The preoperative diagnoses for the TVC group included biliary dyskinesia and symptomatic cholelithiasis. The inclusion criteria in the LC group were less specific, and may include cholecystitis. Some of the LC patients may have been offered, and declined, TVC; however, the data does not differentiate between those who were offered and not offered TVC. The exclusion criteria for TVC patients only were defined as follows: pregnancy; BMI [ 45 kg/m2; undergoing peritoneal dialysis; on immunosuppressive medication or immunocompromised; on therapeutic anticoagulation or anti-platelet therapies or abnormal pre-operative coagulation studies; prior transvaginal surgery; history of pelvic inflammatory disease or suspected severe endometriosis or inability to understand English. Informed consent was obtained for all patients prior to surgery by the operating surgeon in the clinic setting. The learning curve of TVC was measured as the operative time of TVC over the time course of the study. The operative times of LC patients performed during the same time period were also recorded as a baseline (control) of the surgeon (KER) performing the operations. Complications were described for the TVC group only and classified according to Dindo et al. [11], with Grades I and II were considered minor complications and grades III–IV were considered major
123
complications. The LC group complication data were not available within the operative records used in study. The TVC operative technique has been previously described in details elsewhere [4, 12]. In brief, all operations were hybrid TVC with access to the peritoneal cavity initially obtained by placement of a transumbilical 5 mm trocar, followed by placement of a transvaginal 12 mm port under direct laparoscopic visualization. Only standard straight laparoscopic instruments for dissection and specimen retrieval were used. The surgeon had performed 7 transvaginal appendectomies (TVA) prior to the introduction of the TVC to practice. A gynecologist performed the TV access and closure for the initial 5 TVA cases and observed the surgeon (KER) for 15 cases (TVA and TVC) before the surgeon performed the TV procedures independently. The LC patients underwent a standard 4 port LC which has been previously described [4]. A surgical fellow assisted during the TVC, however, which parts of the procedure performed by the attending surgeon or fellow were not differentiated in this study. The operative (OR) time was presented as mean ± SD. The average operative time of TVC at each of four learning periods was compared to the average time for all laparoscopic cholecystectomy (LC) cases during the 3-year period using a one-way ANOVA method, and followed by post hoc pairwise comparisons if there was a significant omnibus F test. All the statistical analyses were conducted using SAS software, version 9.2 (Cary, NC). A two-sided p value of less than 0.05 was considered to indicate statistical significance.
Results Sixty-one female patients underwent a TVC. The average age was 38 ± 12 years and average BMI was 29 ± 6 kg/m2. For comparison, we included 67 female patients who underwent a LC during the same 3-year period (Fig. 1). The average age of LC patients was 41 ± 15 years and average BMI was 33 ± 12 kg/m2. The mean operative (OR) time for TVC was 60 ± 17 min (range 31–94 min). There was no statistically significant difference in OR times between obese (BMI [ 30) and non-obese patients (p = 0.20). As previously described, there were 1 major and 3 minor complications, and 1 conversion to conventional LC (after transvaginal access) [7]. The TVC patients were divided into sequential quartiles (n = 15/ 16), shown in Fig. 1. There was no significant difference in age and BMI between the TVC and LC quartile groups (p = 0.12). And there was no statistically significant difference in age (p = 0.11) and BMI (p = 0.14) between TVC patients in all the four quartiles. The mean TVC operative times for the quartiles were 67 ± 14, 55 ± 19, 56 ± 17, and 64 ± 17 min, respectively. The average OR time of LC was 48 ± 20 min (range 25–136 min), which was significantly lower than that of TVC at first quartile (i.e., starting period)
Surg Endosc p = 0.005
100 p = 0.256
90
p = 0.001
OR time (Minutes)
80
p = 0.584 p = 0.066
p = 0.094
70
Lap Chole TVC: First Quartile TVC: Second Quartile TVC: Third Quartile TVC: Fourth Quartile
60 50 40 30 20 10
rt ile
rt ile rt h
Q ua
Q ua TV C :F ou
rt ile Q ua
TV C :T hi rd
TV C :S ec on d
le C ho La p
TV C :F irs
tQ ua rt ile
0
Fig. 1 Analysis of transvaginal cholecystectomy (TVC) learning curve. TVC patients were divided into sequential quartiles (n = 15/16). Lap chole mean laparoscopic cholecystectomy operative time during the same overall time period
(p = 0.001) and fourth quartile (p = 0.005). No significant differences of OR time were identified between LC and other (i.e., second and third) TVC quartile groups. The average TVC OR time decreased in the second quartile, compared to the first quartile, and stayed relatively constant for third quartile, and then slightly increased in the fourth quartile. However, there was no statistically significant difference among the four TVC quartiles. (Fig. 1) Two additional analyses (Supplemental Fig. 1a, b) were performed whereby the 61 TVC patients were split into sextiles (i.e., groups of 10), and tertiles (i.e., groups of 20), respectively. As shown in Supplemental Fig. 1a, a statistically significant difference was noted when LC operating times compared to the first and second sextile TVC patients (p = 0.001, p = 0.035, respectively). This suggests the learning curve was not peaking after 10 cases. When TVC patients were split into tertiles (Supplemental Fig. 1b), the mean operating times were statistically significant between the LC patients and first tertile of TVC patients (p = 0.001), but not with second tertile (p = 0.157), a trend that was consistent to what were identified when we compared LC patients with TVC quartile groups (Fig. 1). Therefore, these results suggest our conclusion that the learning curve was approximately 15 cases. Two minor complications (IUD dislodgement and urinary retention) occurred in the first quartile. One minor (temporary brachial plexus injury) and 1 major (omental bleed) occurred in the second quartile. The one conversion, after TV access, occurred in the third quartile.
Discussion Minimally invasive laparoscopic surgery has rapidly become the new gold standard for many surgical procedures.
This frontier is continuously forged with new applications of minimally invasive techniques such as single incision (multi-port) laparoscopic surgery (SILS), robotic surgery, and NOTES, which aim to decrease surgical trauma and improve outcomes for the patient. Strides have been made toward the goal of ‘‘scarless’’ surgery, particularly in transvaginal NOTES surgery. Specifically, the hybrid TVC has several advantages other than cosmesis, including faster recovery, decreased pain, and decreased risk of incisional hernia complications [13]. The TVC merges traditional laparoscopic instruments and techniques with the long established transvaginal access approach of gynecologists. Over 1163 TVCs have been reported by international registries and prospective trials of TVCs to date, including Euro-NOTES (n = 435), International Prospective Multicenter Trial on Clinical NOTES (n = 240) and German NOTES registry (n = 488), demonstrating the safety and efficacy of TVC when performed by trained surgeons [1, 2, 14]. Despite growing interest in this procedure, the expected learning curve for a surgeon to introduce the technique to their surgical acumen is poorly defined. Improvement in efficiency of specific surgical technique is difficult to measure in vivo. As such, the use of operative time, though imperfect, has commonly been used as a measure of surgical learning curve in the literature [15–18]. The learning curve of a fellowship-trained minimally invasive surgeon introducing TVC to clinical practice in this study, as measured by improved operative times, was approximately 15 cases. The overall mean operative time for the TVC patients, 60.3 min, was consistent with several previous studies [19–23]. A significant improvement in operative time was noted after the first quartile, and remained comparable to the overall LC operative time during the second and third quartiles. The introduction of a new surgical fellow in the fourth quartile, who was learning the procedure under guidance from the initial surgeon, may have contributed to the increase in operative times seen. However, this study did not differentiate between the fellow and attending surgeon, with different parts of the surgery performed by either person. The short learning curve seen in this study was consistent with two other recent studies [19, 24]. Bulian et al. demonstrated shorter operative times with an increase in TVC procedures performed, with a mean operative time of 82.3 min in the first 25 cases and 73.3 min in the second 25 cases [24]. Van den Boezem et al., similarly, noted that TVC operating time decreased from 90 min to approximately 55 min after only 10 procedures [19]. A different study, Federlein et al., suggests that the learning curve may be shorter for more experienced surgeons, showing a significant decrease in TVC operative times performed by surgeons with [500 LC experience compared to less experienced surgeons [23].
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The lack of TVC complications reported in the third and fourth quartile in this study supports that with increased experience the risk of complication decreases. The introduction of a new surgical fellow did not appear to have a detrimental effect on patient complications. This emphasizes the benefit of introducing the TVC technique under supervision of a surgeon who is familiar with this operative approach, knowledgeable in the potential pitfalls and problems. The learning curve of 15 cases seen in our study may be even less today than when the study was started in 2009, since the technique is now well established and well described in the literature. Skills learned to perform single incision laparoscopic surgery are similarly applied in the hybrid TVC such as adapting to limited triangulation and performing dissection of the gallbladder through a single transumbilical port. However, the single 5 mm port used in a TVC is less traumatic than a SILS procedure, and therefore less likely to have an incisional hernia complication. In contrast to the SILS approach, the specimen extraction technique used in the TVC approach, through the colpotomy incision, avoids further injury to the abdominal wall fascia. Nonetheless, the SILS cholecystectomy may lessen the learning curve of a surgeon who is introducing the TVC to practice. The established skill-set for SILS cholecystectomy, which boasts a short learning curve of approximately 10 cases [17], may be adapted to the hybrid TVC using standard straight laparoscopic instruments. This step-wise introduction of the TVC, with the preceding introduction of SILS cholecystectomy to practice, likely contributed to the relative short learning curve seen in this study. The largest difference between a LC or SILS and the TVC is, of course, the transvaginal colpotomy access and closure, which is not a technique that is typically learned as a general or minimally invasive surgeon. This obstacle is surmounted with initial assistance and supervision by a gynecologist as well as an understanding of specific vaginal landmarks in the posterior fornix, from transvaginal view, and pelvic cul de sac, from the transumbilical view [25]. The optimal technique is critical to avoid injury of surrounding structures occurred during access; specifically, direct transumbilical visualization for TV access, recognizing the appropriate landmarks within the posterior fornix, and angling of the transvaginal trocar anteriorly toward the umbilicus during placement are essential to avoid injury to surrounding structures. Additionally, closure of the colpotomy at the completion of the TVC is performed transvaginally with a running absorbable suture should be directly visualized from the transumbilical port in order to confirm adequate and safe closure. In conclusion, the learning curve of a fellowship-trained surgeon introducing TVC to their surgical repertoire, as measured by improved operative times, can be achieved
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with approximately 15 cases. As with any new procedure, the greater procedure time initially required to perform a TVC should be weighed against the possible postoperative benefits and risks. Acknowledgments This publication was made possible by CTSA Grant Number UL1 RR024139, from the National Center for Research Resources (NCRR) and the National Center for Advancing Translational Science (NCATS), components of the National Institutes of Health (NIH), and NIH roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH. Disclosures Wood, Dai, Dabu-Bondoc, Mikhael, Vadivelu, and Duffy have no conflicts of interest or financial ties to disclose. Dr. Roberts provided consultancy services for Covidien, participated in a Covidien-sponsored grant, and has a patent pending with NovaTract.
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![[Transvaginal cholecystectomy: results of a randomized study].](/assets/img/hold.png)
