Surg Endosc DOI 10.1007/s00464-013-3289-5
and Other Interventional Techniques
A prospective, randomized, controlled, trial comparing occultscar incision laparoscopic cholecystectomy and classic three-port laparoscopic cholecystectomy Lei Zhang • Bijay Sah • Jing Ma • Changzhen Shang Zejian Huang • Yajin Chen
•
Received: 11 July 2013 / Accepted: 15 October 2013 Ó Springer Science+Business Media New York 2013
Abstract Background This study was designed to evaluate the outcome of laparoscopic cholecystectomy by comparing a new technique using occult-scar incision for laparoscopic cholecystectomy (OSLC) with classic three-port laparoscopic cholecystectomy (CLC). In the occult-scar incision, we moved the subcostal and subxiphoid trocar insertion sites to the suprapubic area so that operative scars were hidden in the pubic hairs and below umbilicus. Methods Between July 2009 and 2012, patients undergoing laparoscopic cholecystectomy were randomized to the OSLC or CLC approach after obtaining informed consent. Outcome was measured by operative time, operative complications, hospital length of stay, cost, analgesia required after surgery, and cosmetic outcomes. The patient satisfaction score (PSS) and visual analog score (VAS) also were used to evaluated the level of cosmetic result and postoperative pain. Results A total of 75 patients were randomized into CLC (n = 35) and OSLC (n = 40) groups. No patient was converted to an open procedure in either the CLC or OSLC group. No operative complications were reported within 30 days in either group. The PSS of 7 and 30 days after surgery were both significantly higher in the OSLC group than in the CLC group (5.8 ± 1.5 vs. 8.0 ± 1.1, P = 0.03; 6.5 ± 1.2 vs. 9.2 ± 0.8, P = 0.02). The VAS for pain was significantly lower in the OSLC group on postoperative day 3 compared with the CLC group (2.6 ± 1.2 vs. 6.3 ± 0.9, P = 0.01). There was no significant difference in operative time, hospital stay, and cost between the two groups.
Conclusions The OSLC is a safe and feasible alternative compared with CLC in experienced hands, and it is superior for outcomes regarding pain control and cosmesis. Keywords Laparoscopic cholecystectomy (LC) Classic three-port laparoscopic cholecystectomy (CLC) Occult-scar incision laparoscopic cholecystectomy (OSLC) Randomized controlled trial (RCT)
Laparoscopic cholecystectomy (LC) can be considered one of the most significant surgical procedures of the millennium. LC has now become the procedure of choice for routine gallbladder removal and has become the most common abdominal procedure in most countries [1]. Since its introduction, the technique continues to undergo refinements to reduce both port numbers and sizes in order to further decrease cost, improve recovery time, minimize the postoperative discomfort, and to provide the best cosmesis [2–4]. In the past few years, we developed a new LC technique. The major advantage with this technique is that it uses three occult-scar incisions, which gives the best cosmesis and quicker postoperative recovery without compromising the safety of patients. To evaluate the outcome, a prospective, randomized trial was conducted to compare occult-scar incision laparoscopic cholecystectomy (OSLC) with classic three-port laparoscopic cholecystectomy (CLC).
Patients and methods L. Zhang (&) B. Sah J. Ma C. Shang Z. Huang Y. Chen Department of Hepatobiliary Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, Guangdong Province, China e-mail: [email protected]
The trial was approved by our Institutional Review Board of Memorial Hospital, Sun Yat-sen University. An informed consent was obtained from patients after
123
Surg Endosc
Fig. 1 The position of trocar in classic three-port LC. (A) For laparoscope (10 mm), (B) For ultrasonic scalpel (5 mm), (C) For grasping forceps (5 mm)
Fig. 2 The position of trocar in occult-scar incision LC. (A) For ultrasonic scalpel (10 mm), (B) For grasping forceps (5 mm). (C) For laparoscope (5 mm)
explaining the methods and aims of the trial, as well as the risks related to OSLC and CLC. From July 2009 to July 2012, patients with preoperative diagnosis of symptomatic gallstones or gallbladder polyps planned for elective cholecystectomy at the Department of Hepatobiliary Surgery, Memorial Hospital of Sun Yat-sen University were approached to participate in the trial. The exclusion criteria’s were: (1) high risk for general anesthesia (ASA grade CIII), (2) previous upper or lower abdominal surgery, (3) signs of acute cholecystitis, choledocholithiasis or acute pancreatitis, (4) suspected malignancy or pregnancy(5) obesity (BMI [30 kg/m2) and large body trunk (height [185 cm). All the procedures were performed by one experienced nonblinded surgeon. Patients who agreed to participate in this trial were recruited to the study and were assigned randomly to two groups using a computer-generated randomization chart. Allocation was concealed with an opaque envelope. The randomization was done 1 day before surgery during a preoperative assessment of the patient, and the envelope was opened just before the operation.
monitor was placed above the patients’ right shoulder. Patients were kept in reverse Trendelenburg position with the right side slightly up and the legs low. A 10-mm port was introduced through a 10-mm infraumbilical incision. A 5-mm port was inserted below the xiphoid, and another 5-mm port was placed at the right subcostal region. Dissection was performed with an ultrasonic cautery, starting from Calot’s triangle. The cystic artery and duct were clipped with hem-o-lok clips, respectively. The gallbladder was subsequently dissected from the liver bed and retrieved within the specimen retrieval bag. The umbilical fascia was closed with absorbable sutures.
Operative procedure Under general anesthesia, all patients received a single intravenous dose of prophylactic antibiotics before surgery. CLC and OSLC were performed using two 5-mm ports and one 10-mm port, with a 5-mm 30° camera and the same instruments. Classic three-port LC The surgeon stood to the left of the patient, the nurse to the right, and the assistant to the left of surgeon (Fig. 1). The
123
Occult-scar incision LC The patient’s legs were abducted, and the surgeon stood between the legs (Fig. 2). The assistant stood on the patient’s left and the nurse on the patient’s right. The monitor set was placed above the patients’ right shoulder. A Foley catheter was inserted to decompress the bladder after induction of general anesthesia. After creating pneumoperitoneum and inserting the camera port in the umbilicus, two 5-mm ports were placed under direct visualization on both sides of midline at suprapubic region. Great care is taken while inserting the suprapubic trocars, because the epigastric blood vessels at this region are relatively easy to damage. The laparoscope was then moved from the umbilical port to the left lower port. A 5-mm grasper was inserted through the right port, and ultrasonic cautery was inserted through the umbilical port. The dissection was the same as with the CLC. After the trocar was removed, the gallbladder was then removed via the umbilical port. The Foley catheter was discontinued after recovery from anesthesia.
Surg Endosc
Outcome measures Patients’ demographics, including age, weight, height, as well as the operative duration, length of stay, and postoperative complications within 30 days were collected independently. Pain scores were measured using a visual analogue pain scale (VAS) with a 10-cm scale ranging from no pain (score 0) to worst possible pain (score 10) [5]. All pain assessments were collected in a double-blinded fashion. Local anesthetic was not used in either operation. Pain control was achieved by giving regular Parecoxib 40 mg to each patient after surgery for one time. When the patient was admitted for observation, patients were prescribed postoperative analgesia on demand, intravenous tramadol injection (up to 50 mg 3 times daily). The cosmetic effect (we evaluated it with PSS) was self-assessed by all patients on POD7 and POD30 using a 10-cm scale ranging from poor (score 0) to excellent (score 10) [6]. The assessment also was made by an independent resident. Patients were assessed in the outpatient clinic on POD3, 7, and 30, and the same resident finished the observation during follow-up. No patient lost during follow-up. Statistical analysis PSS and VAS scores were analyzed with Mann–Whitney U test. The differences between groups regarding operative time, hospital stay, and demographic data were compared using t test. All statistical calculations were conducted using SPSS 18.0 statistical software. Power analysis provided by Stat Soft Power Analysis. Significance was defined as P B 0.05.
Results The baseline characteristics between the two groups are shown in Table 1. There were no significant statistical differences between the groups in terms of age, sex, body mass index, and ASA class. The mean operative time was 43.4 ± 22.1 and 40.7 ± 17.4 min in the CLC and OSLC group, respectively (P = 0.67). OSLC had 1.95 days, and CLC had 1.89 days of average length of hospital stay. The mean hospital costs in group A and group B were 2,394 and 2,441 U.S. dollars respectively. There were no additional working ports needed, no conversion to open in either group, no intraoperative bile duct injury, bleeding, or postoperative wound infections. Twenty-one patients in the CLC group (60 %), and 28 patients in the OSLC group (70 %) required intravenous injection of tramadol 50 mg for pain relief during the first 24 h after surgery. There was no significant difference in the postoperative pain score on POD1 in either group (7.2 ± 0.8 vs. 8.0 ± 0.8, P = 0.23).
Table 1 Preoperative parameters CLC (n = 35)
OSLC (n = 40)
P value 0.38
Age (years)
42.4 ± 14.2
47.5 ± 12.6
Sex ratio (F/M)
26/9
30/10
0.44
BMI (kg/m2)
24.3 ± 2.5
23.6 ± 2.7
0.77
I
20
32
0.29
II
15
8
Gallstone
24
30
Gallbladder polyps
9
9
Gallbladder adenoma
2
1
ASA score
Diagnosis 0.22
ASA American Society of Anesthesiology, BMI body mass index, CLC classic three-port laparoscopic cholecystectomy, OSLC occultscar incision laparoscopic cholecystectomy
Table 2 Operative and postoperative parameters CLC (n = 35)
OSLC (n = 40)
P value
Operation time (min)
43.4 ± 22.1
40.7 ± 17.4
0.67
Hospital stay (day)
1 (1–2)
1 (1–3)
0.78
Hospital cost (U.S. dollars)
2,394 ± 167
2,441 ± 204
0.57
Patient required tramadol injection
21 (60 %)
28 (70 %)
0.49
POD1
7.2 ± 0.8
8.0 ± 0.8
0.23
POD 3
6.3 ± 0.9
2.6 ± 1.1
0.01
Visual analog score (VAS)
Patient satisfaction score (PSS) POD 7
5.8 ± 1.5
8.0 ± 1.1
0.03
POD 30
6.5 ± 1.2
9.2 ± 0.8
0.02
CLC classic three-port laparoscopic cholecystectomy, OSLC occultscar incision laparoscopic cholecystectomy, POD postoperative day
However, there was significantly less pain in the OSLC group on POD 3 compared with CLC group (2.6 ± 1.2 vs. 6.3 ± 0.9, P = 0.01). In addition, on POD 7, there was no significant difference in pain score between two groups (2.0 ± 0.7 vs. 2.6 ± 1.2, P = 0.36). The mean patient satisfaction score (PSS) on POD7 and POD30 were both significantly higher in the OSLC group than in the CLC group (5.8 ± 1.5 vs. 8.0 ± 1.1, P = 0.03; 6.5 ± 1.2 vs. 9.2 ± 0.8, P = 0.02). The operative and postoperative outcomes are summarized in Table 2.
Discussion In the modern era of laparoscopic surgery, less visible scar, less postoperative discomfort, less operative trauma, and early return to work are the important goals [7, 8]. Many
123
Surg Endosc
studies have shown the benefit of LC over open cholecystectomy. Natural orifice transluminal endoscopic surgery (NOTES) and single incision laparoscopic cholecystectomy (SILC) have since been developed to further reduce the invasiveness of conventional laparoscopic cholecystectomy. In clinical practice, NOTES faces obvious hurdles in safety [9], and SILC may be considered a more attractive approach. SILC has only one umbilical incision, with better cosmetic outcomes compared to conventional laparoscopic cholecystectomy. However, the umbilical incision in SILC is longer, exposing patients to the risks of postoperative herniation and infection [10]. Furthermore, SILC requires long learning curve and special instruments and is more expensive than conventional LC [11–13]. LC is the most common operation in many hospitals in China, whereas SILC is preformed in only a select few hospitals because of cost and long learning curve. Encouraged with our 20 years experience in the CLC for standard LC in our institute, we tried to develop a new LC technique that fits somewhere between SILC and classic LC. The first patient we operated on using this technique was a young female with a Pfannenstiel incision scar from a prior caesarean section. In order to utilize her scar, we moved the subcostal and subxiphoid trocar to suprapubic area. Then, we found the new operation was not more difficult than the classic LC, and the patient was very satisfied with the outcome. We believe this minor adjustment of the classic LC technique can offer improvement in the comfort of the patients after surgery. The major advantage of the OSLC approach is that operative scars are hidden in the pubic hairs and below the umbilicus. It is a modification of classic threeport LC and is performed with the same instruments and techniques as the three-port LC with the difference being that the two subcostal and subxiphoid trocars are moved to the suprapubic regions where the scars are less exposed. There is no need for a complex learning curve or additional instruments, which is more acceptable in developing countries. The results show that the outcomes from OSLC and CLC were comparable. There were no significant differences in terms of postoperative morbidity, operative duration, length of hospital stays, and hospital cost. No patients were converted to open cholecystectomy in either group, and no patients required additional ports. However, we did find that the pain score and patient satisfactory score were much better in OSLC group than with CLC. More specifically, patients who had OSLC had less pain. This might be due to less neurovascular bundles in the suprapubic region where the incisions were made. One might also account for a psychological contribution to one’s pain experience as the incisions were hidden away from patient’s sight. In addition, patient satisfaction was much higher in OSLC than CLC group in regards to cosmesis.
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Of note, patients with large body trunk and body mass index (BMI) [30 were excluded in this study as we attempted to use the same surgical instruments for both groups. Although the trial includes select patient as per the criteria discussed above, the results are promising in regards to superior pain control and cosmetic outcomes. A larger study may be needed to attempt to validate our results in a more diverse population. For example, using bariatric instruments in patients with BMI [30 may overcome the challenges of body habitus and result in the same benefits shown in our population. Acute cases and patients with previous abdominal surgical history also were excluded due to anticipated peritoneal adhesions and difficulty in identifying normal anatomy. However, we feel that given time and experience, some of these patients can be selected for OSLC based on our experience with standard LC.
Conclusions A new modification for LC is described, which offers a better result in terms of cosmesis and postoperative pain control. However, a large study might be needed to compare the SILC and OSLC to determine whether OSLC can be recommended as a standard and reproducible procedure for LC for a more diverse group of patients. Disclosures Drs. Lei Zhang, Bijay Sah, Jing Ma, Changzhen Shang, Zejian Huang, and Yajin Chen have no conflict of interest or financial ties to disclose.
References 1. Litwin DE, Cahan MA (2008) Laparoscopic cholecystectomy. Surg Clin North Am 88(6):1295–1313 2. Leggett PL, Churchman-Winn R, Miller G (2000) Minimizing ports to improve laparoscopic cholecystectomy. Surg Endosc 14(1):32–36 3. Thakur V, Schlachta CM, Jayaraman S (2011) Minilaparoscopic versus conventional laparoscopic cholecystectomy: a systematic review and meta-analysis. Ann Surg 253(2):244–258 4. Auyang ED, Santos BF, Enter DH et al (2011) Natural orifice translumenal endoscopic surgery (NOTES(R)): a technical review. Surg Endosc 25(10):3135–3148 5. Wong JS, Cheung YS, Fong KW et al (2012) Comparison of postoperative pain between single-incision laparoscopic cholecystectomy and conventional laparoscopic cholecystectomy: prospective case-control study. Surg Laparosc Endosc Percutan Tech 22(1):25–28 6. Garg P, Thakur JD, Singh I et al (2012) A prospective controlled trial comparing single-incision and conventional laparoscopic cholecystectomy: caution before damage control. Surg Laparosc Endosc Percutan Tech 22(3):220–225 7. Soper NJ, Stockmann PT, Dunnegan DL et al (1992) Laparoscopic cholecystectomy. The new ‘gold standard’? Arch Surg 127(8):917–921
Surg Endosc 8. Tenconi SM, Boni L, Colombo EM et al (2008) Laparoscopic cholecystectomy as day-surgery procedure: current indications and patients’ selection. Int J Surg 6:S86–S88 9. Lehmann KS, Ritz JP, Wibmer A et al (2010) The German registry for natural orifice translumenal endoscopic surgery: report of the first 551 patients. Ann Surg 252(2):263–270 10. Lee PC, Lo C, Lai PS et al (2010) Randomized clinical trial of single incision laparoscopic cholecystectomy versus minilaparoscopic cholecystectomy. Br J Surg 97(7):1007–1012 11. Roy P, De A (2010) Transumbilical multiple-port laparoscopic cholecystectomy (TUMP-LC): a prospective analysis of 50 initial patients. J Laparoendosc Adv Surg Tech A 20(3):211–217 12. Fronza JS, Linn JG, Nagle AP et al (2010) A single institution’s experience with single incision cholecystectomy compared to
standard laparoscopic cholecystectomy. Surgery 148(4):731–734; discussion 734–736 13. Hao LX, Liu MY, Zhu HY et al (2012) Single-incision versus conventional laparoscopic cholecystectomy in patients with uncomplicated gallbladder disease: a meta-analysis. Surg Laparosc Endosc Percutan Tech 22(6):487–497
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and Other Interventional Techniques
A prospective, randomized, controlled, trial comparing occultscar incision laparoscopic cholecystectomy and classic three-port laparoscopic cholecystectomy Lei Zhang • Bijay Sah • Jing Ma • Changzhen Shang Zejian Huang • Yajin Chen
•
Received: 11 July 2013 / Accepted: 15 October 2013 Ó Springer Science+Business Media New York 2013
Abstract Background This study was designed to evaluate the outcome of laparoscopic cholecystectomy by comparing a new technique using occult-scar incision for laparoscopic cholecystectomy (OSLC) with classic three-port laparoscopic cholecystectomy (CLC). In the occult-scar incision, we moved the subcostal and subxiphoid trocar insertion sites to the suprapubic area so that operative scars were hidden in the pubic hairs and below umbilicus. Methods Between July 2009 and 2012, patients undergoing laparoscopic cholecystectomy were randomized to the OSLC or CLC approach after obtaining informed consent. Outcome was measured by operative time, operative complications, hospital length of stay, cost, analgesia required after surgery, and cosmetic outcomes. The patient satisfaction score (PSS) and visual analog score (VAS) also were used to evaluated the level of cosmetic result and postoperative pain. Results A total of 75 patients were randomized into CLC (n = 35) and OSLC (n = 40) groups. No patient was converted to an open procedure in either the CLC or OSLC group. No operative complications were reported within 30 days in either group. The PSS of 7 and 30 days after surgery were both significantly higher in the OSLC group than in the CLC group (5.8 ± 1.5 vs. 8.0 ± 1.1, P = 0.03; 6.5 ± 1.2 vs. 9.2 ± 0.8, P = 0.02). The VAS for pain was significantly lower in the OSLC group on postoperative day 3 compared with the CLC group (2.6 ± 1.2 vs. 6.3 ± 0.9, P = 0.01). There was no significant difference in operative time, hospital stay, and cost between the two groups.
Conclusions The OSLC is a safe and feasible alternative compared with CLC in experienced hands, and it is superior for outcomes regarding pain control and cosmesis. Keywords Laparoscopic cholecystectomy (LC) Classic three-port laparoscopic cholecystectomy (CLC) Occult-scar incision laparoscopic cholecystectomy (OSLC) Randomized controlled trial (RCT)
Laparoscopic cholecystectomy (LC) can be considered one of the most significant surgical procedures of the millennium. LC has now become the procedure of choice for routine gallbladder removal and has become the most common abdominal procedure in most countries [1]. Since its introduction, the technique continues to undergo refinements to reduce both port numbers and sizes in order to further decrease cost, improve recovery time, minimize the postoperative discomfort, and to provide the best cosmesis [2–4]. In the past few years, we developed a new LC technique. The major advantage with this technique is that it uses three occult-scar incisions, which gives the best cosmesis and quicker postoperative recovery without compromising the safety of patients. To evaluate the outcome, a prospective, randomized trial was conducted to compare occult-scar incision laparoscopic cholecystectomy (OSLC) with classic three-port laparoscopic cholecystectomy (CLC).
Patients and methods L. Zhang (&) B. Sah J. Ma C. Shang Z. Huang Y. Chen Department of Hepatobiliary Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, Guangdong Province, China e-mail: [email protected]
The trial was approved by our Institutional Review Board of Memorial Hospital, Sun Yat-sen University. An informed consent was obtained from patients after
123
Surg Endosc
Fig. 1 The position of trocar in classic three-port LC. (A) For laparoscope (10 mm), (B) For ultrasonic scalpel (5 mm), (C) For grasping forceps (5 mm)
Fig. 2 The position of trocar in occult-scar incision LC. (A) For ultrasonic scalpel (10 mm), (B) For grasping forceps (5 mm). (C) For laparoscope (5 mm)
explaining the methods and aims of the trial, as well as the risks related to OSLC and CLC. From July 2009 to July 2012, patients with preoperative diagnosis of symptomatic gallstones or gallbladder polyps planned for elective cholecystectomy at the Department of Hepatobiliary Surgery, Memorial Hospital of Sun Yat-sen University were approached to participate in the trial. The exclusion criteria’s were: (1) high risk for general anesthesia (ASA grade CIII), (2) previous upper or lower abdominal surgery, (3) signs of acute cholecystitis, choledocholithiasis or acute pancreatitis, (4) suspected malignancy or pregnancy(5) obesity (BMI [30 kg/m2) and large body trunk (height [185 cm). All the procedures were performed by one experienced nonblinded surgeon. Patients who agreed to participate in this trial were recruited to the study and were assigned randomly to two groups using a computer-generated randomization chart. Allocation was concealed with an opaque envelope. The randomization was done 1 day before surgery during a preoperative assessment of the patient, and the envelope was opened just before the operation.
monitor was placed above the patients’ right shoulder. Patients were kept in reverse Trendelenburg position with the right side slightly up and the legs low. A 10-mm port was introduced through a 10-mm infraumbilical incision. A 5-mm port was inserted below the xiphoid, and another 5-mm port was placed at the right subcostal region. Dissection was performed with an ultrasonic cautery, starting from Calot’s triangle. The cystic artery and duct were clipped with hem-o-lok clips, respectively. The gallbladder was subsequently dissected from the liver bed and retrieved within the specimen retrieval bag. The umbilical fascia was closed with absorbable sutures.
Operative procedure Under general anesthesia, all patients received a single intravenous dose of prophylactic antibiotics before surgery. CLC and OSLC were performed using two 5-mm ports and one 10-mm port, with a 5-mm 30° camera and the same instruments. Classic three-port LC The surgeon stood to the left of the patient, the nurse to the right, and the assistant to the left of surgeon (Fig. 1). The
123
Occult-scar incision LC The patient’s legs were abducted, and the surgeon stood between the legs (Fig. 2). The assistant stood on the patient’s left and the nurse on the patient’s right. The monitor set was placed above the patients’ right shoulder. A Foley catheter was inserted to decompress the bladder after induction of general anesthesia. After creating pneumoperitoneum and inserting the camera port in the umbilicus, two 5-mm ports were placed under direct visualization on both sides of midline at suprapubic region. Great care is taken while inserting the suprapubic trocars, because the epigastric blood vessels at this region are relatively easy to damage. The laparoscope was then moved from the umbilical port to the left lower port. A 5-mm grasper was inserted through the right port, and ultrasonic cautery was inserted through the umbilical port. The dissection was the same as with the CLC. After the trocar was removed, the gallbladder was then removed via the umbilical port. The Foley catheter was discontinued after recovery from anesthesia.
Surg Endosc
Outcome measures Patients’ demographics, including age, weight, height, as well as the operative duration, length of stay, and postoperative complications within 30 days were collected independently. Pain scores were measured using a visual analogue pain scale (VAS) with a 10-cm scale ranging from no pain (score 0) to worst possible pain (score 10) [5]. All pain assessments were collected in a double-blinded fashion. Local anesthetic was not used in either operation. Pain control was achieved by giving regular Parecoxib 40 mg to each patient after surgery for one time. When the patient was admitted for observation, patients were prescribed postoperative analgesia on demand, intravenous tramadol injection (up to 50 mg 3 times daily). The cosmetic effect (we evaluated it with PSS) was self-assessed by all patients on POD7 and POD30 using a 10-cm scale ranging from poor (score 0) to excellent (score 10) [6]. The assessment also was made by an independent resident. Patients were assessed in the outpatient clinic on POD3, 7, and 30, and the same resident finished the observation during follow-up. No patient lost during follow-up. Statistical analysis PSS and VAS scores were analyzed with Mann–Whitney U test. The differences between groups regarding operative time, hospital stay, and demographic data were compared using t test. All statistical calculations were conducted using SPSS 18.0 statistical software. Power analysis provided by Stat Soft Power Analysis. Significance was defined as P B 0.05.
Results The baseline characteristics between the two groups are shown in Table 1. There were no significant statistical differences between the groups in terms of age, sex, body mass index, and ASA class. The mean operative time was 43.4 ± 22.1 and 40.7 ± 17.4 min in the CLC and OSLC group, respectively (P = 0.67). OSLC had 1.95 days, and CLC had 1.89 days of average length of hospital stay. The mean hospital costs in group A and group B were 2,394 and 2,441 U.S. dollars respectively. There were no additional working ports needed, no conversion to open in either group, no intraoperative bile duct injury, bleeding, or postoperative wound infections. Twenty-one patients in the CLC group (60 %), and 28 patients in the OSLC group (70 %) required intravenous injection of tramadol 50 mg for pain relief during the first 24 h after surgery. There was no significant difference in the postoperative pain score on POD1 in either group (7.2 ± 0.8 vs. 8.0 ± 0.8, P = 0.23).
Table 1 Preoperative parameters CLC (n = 35)
OSLC (n = 40)
P value 0.38
Age (years)
42.4 ± 14.2
47.5 ± 12.6
Sex ratio (F/M)
26/9
30/10
0.44
BMI (kg/m2)
24.3 ± 2.5
23.6 ± 2.7
0.77
I
20
32
0.29
II
15
8
Gallstone
24
30
Gallbladder polyps
9
9
Gallbladder adenoma
2
1
ASA score
Diagnosis 0.22
ASA American Society of Anesthesiology, BMI body mass index, CLC classic three-port laparoscopic cholecystectomy, OSLC occultscar incision laparoscopic cholecystectomy
Table 2 Operative and postoperative parameters CLC (n = 35)
OSLC (n = 40)
P value
Operation time (min)
43.4 ± 22.1
40.7 ± 17.4
0.67
Hospital stay (day)
1 (1–2)
1 (1–3)
0.78
Hospital cost (U.S. dollars)
2,394 ± 167
2,441 ± 204
0.57
Patient required tramadol injection
21 (60 %)
28 (70 %)
0.49
POD1
7.2 ± 0.8
8.0 ± 0.8
0.23
POD 3
6.3 ± 0.9
2.6 ± 1.1
0.01
Visual analog score (VAS)
Patient satisfaction score (PSS) POD 7
5.8 ± 1.5
8.0 ± 1.1
0.03
POD 30
6.5 ± 1.2
9.2 ± 0.8
0.02
CLC classic three-port laparoscopic cholecystectomy, OSLC occultscar incision laparoscopic cholecystectomy, POD postoperative day
However, there was significantly less pain in the OSLC group on POD 3 compared with CLC group (2.6 ± 1.2 vs. 6.3 ± 0.9, P = 0.01). In addition, on POD 7, there was no significant difference in pain score between two groups (2.0 ± 0.7 vs. 2.6 ± 1.2, P = 0.36). The mean patient satisfaction score (PSS) on POD7 and POD30 were both significantly higher in the OSLC group than in the CLC group (5.8 ± 1.5 vs. 8.0 ± 1.1, P = 0.03; 6.5 ± 1.2 vs. 9.2 ± 0.8, P = 0.02). The operative and postoperative outcomes are summarized in Table 2.
Discussion In the modern era of laparoscopic surgery, less visible scar, less postoperative discomfort, less operative trauma, and early return to work are the important goals [7, 8]. Many
123
Surg Endosc
studies have shown the benefit of LC over open cholecystectomy. Natural orifice transluminal endoscopic surgery (NOTES) and single incision laparoscopic cholecystectomy (SILC) have since been developed to further reduce the invasiveness of conventional laparoscopic cholecystectomy. In clinical practice, NOTES faces obvious hurdles in safety [9], and SILC may be considered a more attractive approach. SILC has only one umbilical incision, with better cosmetic outcomes compared to conventional laparoscopic cholecystectomy. However, the umbilical incision in SILC is longer, exposing patients to the risks of postoperative herniation and infection [10]. Furthermore, SILC requires long learning curve and special instruments and is more expensive than conventional LC [11–13]. LC is the most common operation in many hospitals in China, whereas SILC is preformed in only a select few hospitals because of cost and long learning curve. Encouraged with our 20 years experience in the CLC for standard LC in our institute, we tried to develop a new LC technique that fits somewhere between SILC and classic LC. The first patient we operated on using this technique was a young female with a Pfannenstiel incision scar from a prior caesarean section. In order to utilize her scar, we moved the subcostal and subxiphoid trocar to suprapubic area. Then, we found the new operation was not more difficult than the classic LC, and the patient was very satisfied with the outcome. We believe this minor adjustment of the classic LC technique can offer improvement in the comfort of the patients after surgery. The major advantage of the OSLC approach is that operative scars are hidden in the pubic hairs and below the umbilicus. It is a modification of classic threeport LC and is performed with the same instruments and techniques as the three-port LC with the difference being that the two subcostal and subxiphoid trocars are moved to the suprapubic regions where the scars are less exposed. There is no need for a complex learning curve or additional instruments, which is more acceptable in developing countries. The results show that the outcomes from OSLC and CLC were comparable. There were no significant differences in terms of postoperative morbidity, operative duration, length of hospital stays, and hospital cost. No patients were converted to open cholecystectomy in either group, and no patients required additional ports. However, we did find that the pain score and patient satisfactory score were much better in OSLC group than with CLC. More specifically, patients who had OSLC had less pain. This might be due to less neurovascular bundles in the suprapubic region where the incisions were made. One might also account for a psychological contribution to one’s pain experience as the incisions were hidden away from patient’s sight. In addition, patient satisfaction was much higher in OSLC than CLC group in regards to cosmesis.
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Of note, patients with large body trunk and body mass index (BMI) [30 were excluded in this study as we attempted to use the same surgical instruments for both groups. Although the trial includes select patient as per the criteria discussed above, the results are promising in regards to superior pain control and cosmetic outcomes. A larger study may be needed to attempt to validate our results in a more diverse population. For example, using bariatric instruments in patients with BMI [30 may overcome the challenges of body habitus and result in the same benefits shown in our population. Acute cases and patients with previous abdominal surgical history also were excluded due to anticipated peritoneal adhesions and difficulty in identifying normal anatomy. However, we feel that given time and experience, some of these patients can be selected for OSLC based on our experience with standard LC.
Conclusions A new modification for LC is described, which offers a better result in terms of cosmesis and postoperative pain control. However, a large study might be needed to compare the SILC and OSLC to determine whether OSLC can be recommended as a standard and reproducible procedure for LC for a more diverse group of patients. Disclosures Drs. Lei Zhang, Bijay Sah, Jing Ma, Changzhen Shang, Zejian Huang, and Yajin Chen have no conflict of interest or financial ties to disclose.
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