Dirk R Bulian1, Jurgen Knuth1, Kai S Lehmann1, Axel Sauerwald1, Markus M Heiss1. 1. Dirk R Bulian, Jurgen Knuth, Markus M Heiss, Department of Abdominal, Vascular and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, 51109 Cologne, Germany.
Abstract
AIM: To evaluate transvaginal hybrid-NOTES cholecystectomy (TVC) during its clinical establishment and compare it with the traditional laparoscopic technique (LC). METHODS: The specific problems and benefits of TVC were reviewed using a registry analysis, a comparative cohort study and a randomized clinical trial. At first, feasibility, safety and specific complications of the TVC were analyzed based on the first 488 data sets of the German NOTES Registry (GNR). Hereafter, we compared the early postoperative results of our first 50 TVC-patients with those of 50 female LC-patients matched by age, BMI and ASA classification. The same cohort was contacted an average of two years later to evaluate long-term results concerning pain and satisfaction with the aesthetic results and the overall postoperative results as well as sexual intercourse by means of two domains of the German version of the Female Sexual Function Index (FSFI-d). Consequently, we performed a randomized clinical trial comparing 20 TVC-patients with 20 needlescopic/3-trocar cholecystectomies (NC) also concerning the early postoperative results as well as pain, satisfaction and quality of life by means of the Eypasch Gastrointestinal Quality of Life Index (GIQLI) in the later course. Finally, we discussed the results in accordance with other published studies. RESULTS: The complication (3.5%) and conversion rates (4.1%) for TVC were low in the GNR and comparable to those of the LC. Access related intraoperative complications included injuries to the bladder (n = 4; 0.8%) and bowel (n = 3; 0.6%). The study cohort revealed less postoperative pain after TVC comparing to the LC-patients on the day of surgery (NRS, 1.5/10 vs 3.1/10, P = 0.003), in the morning (NRS, 1.9/10 vs 2.8/10, P = 0.047) and in the evening (NRS, 1.1/10 vs 1.8/10, P = 0.025) of postoperative day (POD) one. The randomized clinical trial consistently found less cumulative pain until POD 2 (NRS, 8/40 vs 14/40, P = 0.043), as well as until POD 10 (NRS, 22/190 vs 41/190, P = 0.010). Furthermore, the TVC-patients had a better quality of life on POD 10 than did the LC-patients (GIQLI, 124/144 vs 107/144, P = 0.028). The complication rates were comparable and no specific problems were detected in the long-term follow-up for sexual intercourse for either group. The TVC-patients were more satisfied with the aesthetic result in the long-term course in the matched cohort analysis (1.00 vs 1.88, P < 0.001) as well as in the randomized clinical trial (1.00 vs 1.70, P < 0.001) when compared with the LC-patients. CONCLUSION:TVC is a feasible procedure with a high safety profile and has advantages in regard to postoperative pain and aesthetic results when compared with LC or NC.
RCT Entities:
AIM: To evaluate transvaginal hybrid-NOTES cholecystectomy (TVC) during its clinical establishment and compare it with the traditional laparoscopic technique (LC). METHODS: The specific problems and benefits of TVC were reviewed using a registry analysis, a comparative cohort study and a randomized clinical trial. At first, feasibility, safety and specific complications of the TVC were analyzed based on the first 488 data sets of the German NOTES Registry (GNR). Hereafter, we compared the early postoperative results of our first 50 TVC-patients with those of 50 female LC-patients matched by age, BMI and ASA classification. The same cohort was contacted an average of two years later to evaluate long-term results concerning pain and satisfaction with the aesthetic results and the overall postoperative results as well as sexual intercourse by means of two domains of the German version of the Female Sexual Function Index (FSFI-d). Consequently, we performed a randomized clinical trial comparing 20 TVC-patients with 20 needlescopic/3-trocar cholecystectomies (NC) also concerning the early postoperative results as well as pain, satisfaction and quality of life by means of the Eypasch Gastrointestinal Quality of Life Index (GIQLI) in the later course. Finally, we discussed the results in accordance with other published studies. RESULTS: The complication (3.5%) and conversion rates (4.1%) for TVC were low in the GNR and comparable to those of the LC. Access related intraoperative complications included injuries to the bladder (n = 4; 0.8%) and bowel (n = 3; 0.6%). The study cohort revealed less postoperative pain after TVC comparing to the LC-patients on the day of surgery (NRS, 1.5/10 vs 3.1/10, P = 0.003), in the morning (NRS, 1.9/10 vs 2.8/10, P = 0.047) and in the evening (NRS, 1.1/10 vs 1.8/10, P = 0.025) of postoperative day (POD) one. The randomized clinical trial consistently found less cumulative pain until POD 2 (NRS, 8/40 vs 14/40, P = 0.043), as well as until POD 10 (NRS, 22/190 vs 41/190, P = 0.010). Furthermore, the TVC-patients had a better quality of life on POD 10 than did the LC-patients (GIQLI, 124/144 vs 107/144, P = 0.028). The complication rates were comparable and no specific problems were detected in the long-term follow-up for sexual intercourse for either group. The TVC-patients were more satisfied with the aesthetic result in the long-term course in the matched cohort analysis (1.00 vs 1.88, P < 0.001) as well as in the randomized clinical trial (1.00 vs 1.70, P < 0.001) when compared with the LC-patients. CONCLUSION:TVC is a feasible procedure with a high safety profile and has advantages in regard to postoperative pain and aesthetic results when compared with LC or NC.
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