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

Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00007930

Enrollment

800

Registered

2003-01-27

Start date

1999-08-31

Completion date

Unknown

Last updated

2013-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stage I rectal cancer, stage II rectal cancer, stage III rectal cancer

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.

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.

Interventions

PROCEDUREconventional surgery

PROCEDURElaparoscopic surgery

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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 metastatic disease * No evidence of peritoneal or pelvic metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * At least 6 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Neoadjuvant or adjuvant chemoradiotherapy allowed Endocrine therapy: * Not specified Radiotherapy: * See Chemotherapy Surgery: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame
Local recurrence at 3 years	—

Secondary

Measure	Time frame
Disease-free and overall survival at 5 years	—

Countries

China, Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026