A randomized trial of laparoscopic versus open surgery for rectal cancer

H Jaap Bonjer; Charlotte L Deijen; Gabor A Abis; Miguel A Cuesta; Martijn H G M van der Pas; Elly S M de Lange-de Klerk; Antonio M Lacy; Willem A Bemelman; John Andersson; Eva Angenete; Jacob Rosenberg; Alois Fuerst; Eva Haglind; Color II Study Group

doi:10.1056/nejmoa1414882

A randomized trial of laparoscopic versus open surgery for rectal cancer

H Jaap Bonjer, Charlotte L Deijen, Gabor A Abis, Miguel A Cuesta, Martijn H G M van der Pas, Elly S M de Lange-de Klerk, Antonio M Lacy, Willem A Bemelman, John Andersson, Eva Angenete, Jacob Rosenberg, Alois Fuerst, Eva Haglind, Color II Study Group

Department of Clinical Medicine

646 Citations (Scopus)

Abstract

Background: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). Conclusions: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery.

Original language	English
Journal	New England Journal of Medicine
Volume	372
Issue number	14
Pages (from-to)	1324-32
Number of pages	9
ISSN	0028-4793
DOIs	https://doi.org/10.1056/nejmoa1414882
Publication status	Published - 2 Apr 2015

Keywords

Adenocarcinoma
Aged
Digestive System Surgical Procedures
Disease-Free Survival
Female
Humans
Laparoscopy
Male
Middle Aged
Neoplasm Recurrence, Local
Neoplasm Staging
Rectal Neoplasms
Survival Rate

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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http://diposit.ub.edu/dspace/bitstream/2445/112376/1/666338.pdf

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Bonjer, H. J., Deijen, C. L., Abis, G. A., Cuesta, M. A., van der Pas, M. H. G. M., de Lange-de Klerk, E. S. M., Lacy, A. M., Bemelman, W. A., Andersson, J., Angenete, E., Rosenberg, J., Fuerst, A., Haglind, E., & Color II Study Group (2015). A randomized trial of laparoscopic versus open surgery for rectal cancer. New England Journal of Medicine, 372(14), 1324-32. https://doi.org/10.1056/nejmoa1414882

Bonjer, HJ, Deijen, CL, Abis, GA, Cuesta, MA, van der Pas, MHGM, de Lange-de Klerk, ESM, Lacy, AM, Bemelman, WA, Andersson, J, Angenete, E, Rosenberg, J, Fuerst, A, Haglind, E & Color II Study Group 2015, 'A randomized trial of laparoscopic versus open surgery for rectal cancer', New England Journal of Medicine, vol. 372, no. 14, pp. 1324-32. https://doi.org/10.1056/nejmoa1414882

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title = "A randomized trial of laparoscopic versus open surgery for rectal cancer",

abstract = "Background: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). Conclusions: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery.",

keywords = "Adenocarcinoma, Aged, Digestive System Surgical Procedures, Disease-Free Survival, Female, Humans, Laparoscopy, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Rectal Neoplasms, Survival Rate",

author = "Bonjer, {H Jaap} and Deijen, {Charlotte L} and Abis, {Gabor A} and Cuesta, {Miguel A} and {van der Pas}, {Martijn H G M} and {de Lange-de Klerk}, {Elly S M} and Lacy, {Antonio M} and Bemelman, {Willem A} and John Andersson and Eva Angenete and Jacob Rosenberg and Alois Fuerst and Eva Haglind and {Color II Study Group}",

year = "2015",

month = apr,

day = "2",

doi = "10.1056/nejmoa1414882",

language = "English",

volume = "372",

pages = "1324--32",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "14",

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TY - JOUR

T1 - A randomized trial of laparoscopic versus open surgery for rectal cancer

AU - Bonjer, H Jaap

AU - Deijen, Charlotte L

AU - Abis, Gabor A

AU - Cuesta, Miguel A

AU - van der Pas, Martijn H G M

AU - de Lange-de Klerk, Elly S M

AU - Lacy, Antonio M

AU - Bemelman, Willem A

AU - Andersson, John

AU - Angenete, Eva

AU - Rosenberg, Jacob

AU - Fuerst, Alois

AU - Haglind, Eva

AU - Color II Study Group

PY - 2015/4/2

Y1 - 2015/4/2

N2 - Background: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). Conclusions: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery.

AB - Background: Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results: A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8). Conclusions: Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery.

KW - Adenocarcinoma

KW - Aged

KW - Digestive System Surgical Procedures

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Laparoscopy

KW - Male

KW - Middle Aged

KW - Neoplasm Recurrence, Local

KW - Neoplasm Staging

KW - Rectal Neoplasms

KW - Survival Rate

U2 - 10.1056/nejmoa1414882

DO - 10.1056/nejmoa1414882

M3 - Journal article

C2 - 25830422

SN - 0028-4793

VL - 372

SP - 1324

EP - 1332

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 14

ER -

A randomized trial of laparoscopic versus open surgery for rectal cancer

Abstract

Keywords

UN SDGs

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