Prospective Comparison of Short-term Outcomes Between Hybrid Notes Transvaginal Cholecystectomy and Laparoscopic Cholecystectomy

Byron F Santos, MD, Eric S Hungness, MD, Ezra Teitelbaum, MD, Fahd O Arafat, MD, Magdy P Milad, MD, Nathaniel J Soper. Northwestern University

Introduction: A natural orifice transluminal endoscopic surgery (NOTES) approach has been recently applied to a number of intra-abdominal operations and offers the potential of reducing post-operative pain and convalescence. Here we present a single-institution series of hybrid NOTES transvaginal cholecystectomies (TVC) and compare short-term outcomes with patients undergoing traditional laparoscopic cholecystectomy (LC).

Methods: All patients had an indication for elective cholecystectomy and met the following IRB approved inclusion criteria: female gender, age > 18 years, BMI < 35, ASA classification I or II, and absence of acute cholecystitis. TVC was performed using one or two transabdominal ports to enable gallbladder retraction and clip application. Dissection was performed with a flexible endoscope through a posterior colpotomy using instrumentation from the Advanced Toolbox for Minimally Invasive Surgery from Ethicon Endo-Surgery (Cincinnati, OH). LC was performed using four trocars and standard instrumentation. Unpaired t-tests were used to compare results.

Results: 7 patients underwent TVC and 7 patients underwent LC. Pre-operative demographics were similar between the two groups, including mean age (38 vs. 34; p = n.s.) and BMI (29 vs. 27; p = n.s.). Operative times were significantly longer for the TVC group (162 ±29 vs. 68 ±21 minutes; p < 0.001), whereas EBL was similar (39 vs. 8 ml; p = n.s.). All procedures were performed on an outpatient basis, except for one patient in each group who were discharged on POD #1. Three minor (Grade 1) complications occurred, two in the LC group and one in the TVC group. TVC patients required significantly less narcotics in the PACU (mean 1.3 ±1.7 vs. 8.2 ±5.9 mg IV morphine equivalents; p = .02). Mean VAS pain scores (scale 0-10) in the PACU were less in the TVC group at 30 minutes (1.1 ±1.3 vs. 5.1 ±3.1; p = .02) and 60 minutes (1.7 ±1.6 vs. 4.7 ±2.5; p = .02). Pain scores were also lower in the TVC group on post-operative days 1, 4 and 7 (2.4, 1, 0.1 vs. 5.9, 2.5, 2), although only significantly on POD #1 (p = .01). SF-36 Health Survey and McGill Pain Questionnaire scores were similar between groups at one month post-operatively. There was no difference between Sexual Function Questionnaire scores before and three months after TVC.

Conclusions: This series adds to the existing evidence that hybrid NOTES transvaginal cholecystectomy using a flexible endoscope for dissection is technically feasible and a safe procedure in women requiring elective surgery. TVC requires a longer operative time than LC but may result in less pain with patients subsequently requiring fewer narcotics. Further evidence is needed to validate these findings and a multi-center randomized controlled trial is currently in progress.