Annals of surgery · 2018
Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Maggiori Léon, Tuech Jean Jacques, Cotte Eddy, Lelong Bernard, Denost Quentin, Karoui Mehdi, Vicaut Eric, Panis Yves
Аннотация
OBJECTIVE: To compare outcome of single-port laparoscopy (SPL) and multiport laparoscopy (MPL) laparoscopy for colonic surgery.
SUMMARY OF BACKGROUND DATA: Benefits of SPL over MPL are yet to be demonstrated in large randomized trials.
METHODS: In this prospective, double-blinded, superiority trial, patients undergoing laparoscopic colonic resection for benign or malignant disease were randomly assigned to SPL or MPL (NCT01959087). Primary outcome was length of theoretical hospital stay (LHS).
RESULTS: One hundred twenty-eight patients were randomized and 125 analyzed: 62 SPL and 63 MPL, including 91 right (SPL: n = 44, 71%; MPL: n = 47, 75%) and 34 left (SPL: n = 18, 29%; MPL: n = 16, 25%) colectomies, performed for Crohn disease (n = 53, 42%), cancer (n = 36, 29%), diverticulitis (n = 21, 17%), or benign neoplasia (n = 15, 12%). Additional port insertion was required in 5 (8%) SPL patients and conversion to laparotomy occurred in 7 patients (SPL: n = 3, 5%; MPL: n = 4, 7%; P = 1.000). Total length of skin incision was significantly shorter in the SPL group [SPL: 56 ± 41 (range, 30-300) mm; MPL: 87 ± 40 (50-250) mm; P < 0.001]. Procedure duration, intraoperative complication rate, postoperative 30-day morbidity, postoperative pain, and time to first bowel movement were similar between the groups, leading to similar theoretical LHS (SPL: 6 ± 3 days; MPL: 6 ± 2; P = 0.298). At 6 months, quality of life was similar between groups, but patients from the SPL group were significantly more satisfied with their scar aspect than patients from the MPL group (P = 0.003).
CONCLUSION: SPL colectomy does not confer any additional benefit other than cosmetic result, as compared to MPL.
SUMMARY OF BACKGROUND DATA: Benefits of SPL over MPL are yet to be demonstrated in large randomized trials.
METHODS: In this prospective, double-blinded, superiority trial, patients undergoing laparoscopic colonic resection for benign or malignant disease were randomly assigned to SPL or MPL (NCT01959087). Primary outcome was length of theoretical hospital stay (LHS).
RESULTS: One hundred twenty-eight patients were randomized and 125 analyzed: 62 SPL and 63 MPL, including 91 right (SPL: n = 44, 71%; MPL: n = 47, 75%) and 34 left (SPL: n = 18, 29%; MPL: n = 16, 25%) colectomies, performed for Crohn disease (n = 53, 42%), cancer (n = 36, 29%), diverticulitis (n = 21, 17%), or benign neoplasia (n = 15, 12%). Additional port insertion was required in 5 (8%) SPL patients and conversion to laparotomy occurred in 7 patients (SPL: n = 3, 5%; MPL: n = 4, 7%; P = 1.000). Total length of skin incision was significantly shorter in the SPL group [SPL: 56 ± 41 (range, 30-300) mm; MPL: 87 ± 40 (50-250) mm; P < 0.001]. Procedure duration, intraoperative complication rate, postoperative 30-day morbidity, postoperative pain, and time to first bowel movement were similar between the groups, leading to similar theoretical LHS (SPL: 6 ± 3 days; MPL: 6 ± 2; P = 0.298). At 6 months, quality of life was similar between groups, but patients from the SPL group were significantly more satisfied with their scar aspect than patients from the MPL group (P = 0.003).
CONCLUSION: SPL colectomy does not confer any additional benefit other than cosmetic result, as compared to MPL.