COLOR: A Randomized Clinical Trial Comparing Laparoscopic and Open Resection for Colon Cancer

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Abstract

Background: Laparoscopic surgery has proven to be safe and effective. However, the value of laparoscopic resection for malignancy in terms of cancer outcome can only be assessed by large prospective randomized clinical trials with sufficient follow-up. Methods: COLOR (COlon carcinoma Laparoscopic or Open Resection) is a European multicenter randomized trial which has started in September 1997. In 24 hospitals in Sweden, The Netherlands, Germany, France, Italy and Spain, 1,200 patients will be included. The primary end point of the study is cancer-free survival after 3 years. Results: Within <2 years, more than 540 patients have been randomized for right hemicolectomy (45%), left hemicolectomy (10%) and sigmoidectomy (45%). 33 patients (6%) were excluded after randomization. The accrual rate is approximately 25 patients/month. Current survival rates for the whole study group are: stage I: 95%, stage II: 98%, stage III: 93%, stage IV: 64%. For all patients with stage I disease, the mortality was not cancer related. Conclusions: Although laparoscopic surgery appears of value in colorectal malignancy, results of randomized trials have to be awaited to determine the definitive place of laparoscopy in colorectal cancer. Considering the current accrual rate, the COLOR study will be completed in 2002.

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Impact of gas(less) laparoscopy and laparotomy on peritoneal tumor growth and abdominal wall metastases.

R. Marquet, N. Bouvy, H Jeekel … (1996)

A tumor model in the rat was used to study peritoneal tumor growth and abdominal wall metastases after carbon dioxide (CO2) pneumoperitoneum, gasless laparoscopy, and laparotomy. The role of laparoscopic resection of cancer is under debate. Insufflation of the peritoneal cavity with CO2 is believed to be a causative factor in the development of abdominal wall metastases after laparoscopic resection of malignant tumors. In the solid tumor model, a lump of 350-mg CC-531 tumor cells was placed intraperitoneally in rats having CO2 pneumoperitoneum (n = 8), gasless laparoscopy (n = 8), or conventional laparotomy (n = 8). After 20 minutes, the solid tumor was removed through a laparoscopic port or through the laparotomy. In the cell seeding model, 5 x 10(5) CC-531 cells were injected intraperitoneally before CO2 pneumoperitoneum (n = 12), gasless laparoscopy (n = 12), or laparotomy (n = 12). All operative procedures lasted 20 minutes. After 6 weeks, in the solid tumor model and after 4 weeks in the cell seeding model, tumor growth was scored semiquantitatively. All results were analyzed using the analysis of variance. In the solid tumor model, peritoneal tumor growth in the laparotomy group was greater than in the CO2 pneumoperitoneum group (p < 0.01). Peritoneal tumor growth in the CO2 group was greater than in the gasless group (p < 0.01). The size of abdominal wall metastases was greater at the port site of extraction of the tumor than at the other port sites (p < 0.001). In the cell seeding model, peritoneal tumor growth was greater after laparotomy in comparison to CO2 pneumoperitoneum (p < 0.02). Peritoneal tumor growth in the CO2 group was greater than in the gasless group (p < 0.01). The port site metastases in the CO2 group were greater than in the gasless group (p < 0.01). The following conclusions can be made: 1) that direct contact between solid tumor and the port site enhances local tumor growth, 2) that laparoscopy is associated with less intraperitoneal tumor growth than laparotomy, and 3) that insufflation of CO2 promotes tumor growth at the peritoneum and is associated with greater abdominal wall metastases than gasless laparoscopy.

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Laparoscopic resection does not adversely affect early survival curves in patients undergoing surgery for colorectal adenocarcinoma.

R Grégoire, N Roy, E Poulin … (1999)

To determine the survival curves for laparoscopic resection (LR) of colorectal cancer. Laparoscopic resection for cure of colorectal cancer is controversial, and survival curves have not been determined. A prospective database of 177 consecutive LRs of colorectal cancers performed between November 1991 and 1997 was reviewed. The TNM classification (stage 0, I, II, III, and IV) for colorectal cancers and the Kaplan-Meier method were used to determine survival curves. Of the 177 patients, 5 were excluded for not having adenocarcinomas. Twenty-five patients (14.5%) had conversion to open surgery; most of these patients had rectal cancer or tumor invasion to adjacent organs. Twelve patients were lost to follow-up. All 135 remaining patients had follow-up. Overall, 28 deaths occurred during the follow-up period, 15 of which were cancer-related. The median follow-up was 24 months for patients with stage I, II, and III disease and 9 months for patients with stage IV disease. Observed 2-year survival rates were 100% stage I, 88.7% stage II, 80.6% stage III, and 28.6% stage IV. Survival rates at 4 years were 100% stage I, 79.5% stage II, 53.7% stage III, and 0% stage IV. No trocar site recurrence was observed. Early survival curves for patients with colorectal cancer who underwent LR do not differ negatively from historical controls for conventional surgery. Further validation is needed.

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Port-site metastases

Larissa N. L. Tseng, F. Berends, Ph. Wittich … (1998)

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Author and article information

Journal

Journal ID (publisher-id): DSU

Journal ID (nlm-ta): Dig Surg

Journal ID (doi): 10.1159/issn.0253-4886

Title: Digestive Surgery

Publisher: S. Karger AG

ISSN (Print): 0253-4886

ISSN (Electronic): 1421-9883

Publication date Subscription-year: 2000

Publication date (Print): 2000

Publication date (Electronic): 16 January 2001

Volume: 17

Issue: 6

Pages: 617-622

Article

Publisher ID: 51971 Other ID: Dig Surg 2000;17:617–622

DOI: 10.1159/000051971

PubMed ID: 11155008

SO-VID: 868e9aba-ac1e-4caf-a934-737388a2258d

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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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COLOR: A Randomized Clinical Trial Comparing Laparoscopic and Open Resection for Colon Cancer

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Karger: Gastroenterology

Most cited references 3

Impact of gas(less) laparoscopy and laparotomy on peritoneal tumor growth and abdominal wall metastases.

Laparoscopic resection does not adversely affect early survival curves in patients undergoing surgery for colorectal adenocarcinoma.

Port-site metastases

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Cited by 20

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