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OpenTrials
Completed

NCT Number: NCT00238381

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kreiskrankenhaus Lörrach, Loerrach, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

  • 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)

Treatment and study plan

5 cm colon-J-pouch

Procedure

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

side-to-end anastomosis

Procedure

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

straight coloanal anastomosis

Procedure

straight coloanal anastomosis with/without temporary protective ileostomy

Primary outcomes

  1. Composite evacuation score after total mesorectal excision

    Time frame: 12 months after surgery

Secondary outcomes

  1. Composite evacuation score at 6, 18, and 24 months after total mesorectal excision

    Time frame: 6, 18 and 24 months after surgery

  2. Composite incontinence score after total mesorectal excision

    Time frame: 6, 12, 18 and 24 months

  3. Quality of life after total mesorectal excision

    Time frame: 6, 12m 18 and 24 months

  4. Overall survival

    Time frame: 2 years follow-up

  5. Morbidity

    Time frame: 2 years follow-up

Sponsors and collaborators

Lead sponsor

Swiss Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2016
First posted
Oct 13, 2005
Registry last updated
May 15, 2019

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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