Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer

Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238381

Enrollment

336

Registered

2005-10-13

Start date

2005-07-31

Completion date

2016-08-31

Last updated

2019-05-15

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

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the rectum, stage 0 rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent rectal cancer

Brief summary

RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery. PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.

Detailed description

This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (\> 5 cm vs ≤ 5 cm), age (\< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.

Interventions

PROCEDURE5 cm colon-J-pouch

5 cm colon-J-pouch with/without temporary protective ileostomy

PROCEDUREside-to-end anastomosis

side-to-end anastomosis with/without temporary protective ileostomy

PROCEDUREstraight coloanal anastomosis

straight coloanal anastomosis with/without temporary protective ileostomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy * Total mesorectal excision needed * Age ≥ 18 years * Clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools) * Any T, any N, any M or adenoma * An R0-resection is expected (liver metastases planned to be simultaneously * Written informed consent, signed and dated by the patient and the investigator * Completed baseline quality of life questionnaire

Exclusion criteria

* Rectal tumor other than adenocarcinoma or adenoma * Previous rectal cancer surgery, other than local excision within the last 2 months * Histologically proven chronic inflammatory bowel disease * Contraindications to any of the 3 surgical techniques * BMI \> 35 * Patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the QL questionnaires and/or following the structured interview * Inability to read and understand any of the languages available on the QL questionnaires,and spoken during the interview (German, French, Italian)

Design outcomes

Primary

Measure	Time frame
Composite evacuation score after total mesorectal excision	12 months after surgery

Secondary

Measure	Time frame
Composite evacuation score at 6, 18, and 24 months after total mesorectal excision	6, 18 and 24 months after surgery
Composite incontinence score after total mesorectal excision	6, 12, 18 and 24 months
Quality of life after total mesorectal excision	6, 12m 18 and 24 months
Overall survival	2 years follow-up
Morbidity	2 years follow-up

Countries

Germany, Switzerland

Outcome results

None listed

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