Léon Maggiori1, Eric Rullier, Jérémie H Lefevre, Jean-Marc Régimbeau, Stéphane Berdah, Mehdi Karoui, Jérome Loriau, Arnaud Alvès, Eric Vicaut, Yves Panis. 1. *Colorectal Surgery Department, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, University Paris VII, Clichy, France †Colorectal unit, Hôpital Haut Lévêque, CHU Bordeaux, University of Bordeaux, Bordeaux, France ‡Digestive Surgery Department, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Pierre & Marie Curie University (Paris VI), Paris, France §Department of Digestive and Oncological Surgery, Amiens-Picardie University Medical Center, Amiens, France ¶Department of Digestive Surgery, Hôpital Nord, Aix-Marseille University, Marseille, France ||Department of Digestive and Hepato-Pancreato-Biliary Surgery, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre & Marie Curie University (Paris VI), Paris, France **Department of Digestive Surgery, Hôpital Saint-Joseph, Paris, France ††Department of Digestive Surgery, University Hospital of Caen, University of Caen Normandy, Caen, France ‡‡Department of Clinical Research, Hôpital Lariboisière, Assistance publique-Hôpitaux de Paris, University Paris VII, Paris, France.
Abstract
OBJECTIVE: The aim of this study was to assess whether association of laparoscopic approach and full fast track multimodal (FFT) management can reduce postoperative morbidityafter colorectal cancer surgery, as compared to laparoscopic approach with limited fast-track program (LFT). SUMMARY OF BACKGROUND DATA: Recent advances in colorectal cancer surgery are introduction of laparoscopy and FFT implementation. METHODS:Patients eligible for elective laparoscopic colorectal cancer surgery were randomized into 2 groups: FFT or LFT care (with only early oral intake and mobilization starting on Day 1). Primary outcome was postoperative 30-day morbidity, according to Clavien-Dindo classification. RESULTS:Two hundred seventy patients were randomized and 263 were analyzed: 130 in FFT group and 133 in LFT group, including 106 colon (FFT: n = 52 and LFT: n = 54) and 157 rectal cancer (FFT: n = 78 and LFT: n = 79). Postoperative 30-day mortality was nil. Overall postoperative 30-day morbidity did not show any difference between the groups (FFT: 35% vs LFT: 29%, P = 0.290), neither regarding the overall population, nor in the colon (FFT: 23% vs LFT: 19%, P = 0.636) or rectal (FFT: 44% vs LFT: 35%, P = 0.330) cancer subgroups. Severe postoperative morbidity was also not different between groups (FFT: 12% vs LFT: 8%, P = 0.266). After multivariate regression analysis, only early intravenous catheter removal (on day 2) [odds ratio: 0.390; 95% confidence interval: (95% CI 0.181-0.842); P = 0.017] and the absence of intraoperative lidocaine intravenous perfusion (odds ratio: 0.182, 95% CI 0.042-0.788; P = 0.019) were identified as independent predictive factors of reduced postoperative morbidity. CONCLUSION: Addition of FFT multimodal management to laparoscopic approach with early oral intake and mobilization does not reduce postoperative morbidityafter colorectal cancer surgery.
RCT Entities:
OBJECTIVE: The aim of this study was to assess whether association of laparoscopic approach and full fast track multimodal (FFT) management can reduce postoperative morbidity after colorectal cancer surgery, as compared to laparoscopic approach with limited fast-track program (LFT). SUMMARY OF BACKGROUND DATA: Recent advances in colorectal cancer surgery are introduction of laparoscopy and FFT implementation. METHODS:Patients eligible for elective laparoscopic colorectal cancer surgery were randomized into 2 groups: FFT or LFT care (with only early oral intake and mobilization starting on Day 1). Primary outcome was postoperative 30-day morbidity, according to Clavien-Dindo classification. RESULTS: Two hundred seventy patients were randomized and 263 were analyzed: 130 in FFT group and 133 in LFT group, including 106 colon (FFT: n = 52 and LFT: n = 54) and 157 rectal cancer (FFT: n = 78 and LFT: n = 79). Postoperative 30-day mortality was nil. Overall postoperative 30-day morbidity did not show any difference between the groups (FFT: 35% vs LFT: 29%, P = 0.290), neither regarding the overall population, nor in the colon (FFT: 23% vs LFT: 19%, P = 0.636) or rectal (FFT: 44% vs LFT: 35%, P = 0.330) cancer subgroups. Severe postoperative morbidity was also not different between groups (FFT: 12% vs LFT: 8%, P = 0.266). After multivariate regression analysis, only early intravenous catheter removal (on day 2) [odds ratio: 0.390; 95% confidence interval: (95% CI 0.181-0.842); P = 0.017] and the absence of intraoperative lidocaine intravenous perfusion (odds ratio: 0.182, 95% CI 0.042-0.788; P = 0.019) were identified as independent predictive factors of reduced postoperative morbidity. CONCLUSION: Addition of FFT multimodal management to laparoscopic approach with early oral intake and mobilization does not reduce postoperative morbidity after colorectal cancer surgery.
Authors: Omid Madadi-Sanjani; Christoph Zoeller; Joachim F Kuebler; Alejandro D Hofmann; Jens Dingemann; Soeren Wiesner; Julia Brendel; Benno M Ure Journal: BJS Open Date: 2021-11-09
Authors: Marius Schwab; Niall Brindl; Alexander Studier-Fischer; Thomas Tu; Julia Gsenger; Max Pilgrim; Mirco Friedrich; Pia-Elena Frey; Christina Achilles; Alexander Leuck; Thore Bürgel; Manuel Feisst; Christina Klose; Solveig Tenckhoff; Colette Dörr-Harim; André L Mihaljevic Journal: Trials Date: 2020-03-23 Impact factor: 2.279