Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007930
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: conventional surgery Procedure: laparoscopic surgery Phase 3

Detailed Description:


  • Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.
  • Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
  • Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.
  • Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later.

Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 800 patients (400 per arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Primary Purpose: Treatment
Official Title: Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
Study Start Date : August 1999

Primary Outcome Measures :
  1. Local recurrence at 3 years

Secondary Outcome Measures :
  1. Disease-free and overall survival at 5 years

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Clinical diagnosis of rectal cancer by colonoscopy or barium enema

    • Distal margin of tumor arises within 9-15 cm from the anal verge as measured by rigid sigmoidoscopy
  • No synchronous multiple adenocarcinomas
  • Candidate for low anterior surgical resection by laparoscopy or conventional open method
  • No evidence of gross metastatic disease
  • No evidence of peritoneal or pelvic metastases



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • At least 6 months


  • Not specified


  • Not specified


  • Not specified


  • No other malignancy within the past 5 years


Biologic therapy:

  • Not specified


  • Neoadjuvant or adjuvant chemoradiotherapy allowed

Endocrine therapy:

  • Not specified


  • See Chemotherapy


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00007930

Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, China
Contact: Samuel P.Y. Kwok, MD    852-2899-2217   
Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, China
Contact: Michael K.W. Li, FRCS, FHKAM    852-2595-6389   
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169608
Contact: Heah Sieu Min, MD    65-6526-5247      
Sponsors and Collaborators
National Medical Research Council (NMRC), Singapore
Study Chair: Heah Sieu Min, MD National Cancer Centre, Singapore Identifier: NCT00007930     History of Changes
Other Study ID Numbers: CDR0000068354
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: December 2006

Keywords provided by National Cancer Institute (NCI):
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases