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Completed

NCT Number: NCT00147134

A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fujita Health University, Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan

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About this study

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven colorectal carcinoma
  • Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
  • T3 or deeper lesion without involvement of other organs
  • Without multiple lesion other than carcinoma in situ
  • Cancer classified as N0-2 and M0, according to the TNM classification system
  • Tumor size < 8 cm
  • No bowel obstruction
  • Age 20 < and > 75 years
  • Sufficient organ function
  • No history of gastrointestinal surgery
  • No history of chemotherapy or radiotherapy
  • Provided written informed consent

Exclusion criteria

  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  • Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
  • Pregnant or lactating women
  • Severe mental disease
  • Continuous systemic steroid therapy

Treatment and study plan

open colectomy

Procedure

Procedure/Surgery: open colectomy

laparoscopic colectomy

Procedure

Procedure/Surgery: laparoscopic colectomy

Primary outcomes

  1. Overall survival

    Time frame: During the study conduct

Secondary outcomes

  1. Relapse-free survival

    Time frame: During the study conduct

  2. Short-term clinical outcomes

    Time frame: time to 1st discharge after operation

  3. Adverse events

    Time frame: During the study conduct

  4. The proportion of conversion from LAP to OPEN

    Time frame: operation day

  5. The proportion of completion of LAP

    Time frame: operation day

Sponsors and collaborators

Lead sponsor

Haruhiko Fukuda

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Sep 7, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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