ClinicalTrials.gg
Status unknownNCT00007930Updated Aug 26, 2013

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

A Phase 3 interventional study of conventional surgery and laparoscopic surgery in Colorectal Cancer, sponsored by National Medical Research Council (NMRC), Singapore. Status unknown at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-26.

Primary conditionRectal NeoplasmsRegistry: Colorectal NeoplasmsReclassifiedWhy we changed it
Registry
Colorectal Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Rectal Neoplasms
Why
  1. The study's title name Rectal Neoplasms, a narrower term within Colorectal Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Medical Research Council (NMRC), Singapore · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Colorectal Cancer

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Keywords

  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
03

In context

Rectal Neoplasms Reclassified

2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.

This study's planned enrollment of 800 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

National Medical Research Council (NMRC), Singapore is the lead sponsor of 5 studies on the registry; none are open to participants now.

Compared within Rectal Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Colorectal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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 disease
  • No evidence of peritoneal or pelvic metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

:

  • At least 6 months

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • or adjuvant chemoradiotherapy allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Chemotherapy

Surgery:

  • See Disease Characteristics
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Enrollment
800 participants (estimated)

Interventions

  • Procedureconventional surgery
  • Procedurelaparoscopic surgery
06

What researchers measure

Primary outcomes

  1. Local recurrence at 3 years

Secondary outcomes

  1. Disease-free and overall survival at 5 years

07

Study locations

3 of 3 sites recruiting
  • Hong Kong Sanatorium & Hospital
    Hong Kong, China
    Recruiting
  • Pamela Youde Nethersole Eastern Hospital
    Hong Kong, China
    Recruiting
    • Michael K.W. Li, FRCS, FHKAM · Contactmkwli@ha.org.hk · 852-2595-6389
  • National Cancer Centre - Singapore
    Singapore, 169608, Singapore
    Recruiting
    • Heah Sieu Min, MD · Contact65-6526-5247
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00007930
Lead sponsor
National Medical Research Council (NMRC), Singapore
First posted
Jan 27, 2003
Start date
Aug 1999
Last update
Aug 26, 2013

Study contacts

Heah Sieu Min, MD
study chair · National Cancer Centre, Singapore
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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