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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00238381
First received: October 12, 2005
Last updated: May 26, 2014
Last verified: May 2014

October 12, 2005
May 26, 2014
July 2005
May 2014   (final data collection date for primary outcome measure)
Composite evacuation score after total mesorectal excision [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00238381 on ClinicalTrials.gov Archive Site
  • Composite evacuation score at 6, 18, and 24 months after total mesorectal excision [ Time Frame: 6, 18 and 24 months after surgery ] [ Designated as safety issue: No ]
  • Composite incontinence score after total mesorectal excision [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Quality of life after total mesorectal excision [ Time Frame: 6, 12m 18 and 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Procedure: 5 cm colon-J-pouch
    5 cm colon-J-pouch with/without temporary protective ileostomy
  • Procedure: side-to-end anastomosis
    side-to-end anastomosis with/without temporary protective ileostomy
  • Procedure: straight coloanal anastomosis
    straight coloanal anastomosis with/without temporary protective ileostomy
  • Arm I
    Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
    Intervention: Procedure: side-to-end anastomosis
  • Arm II
    Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
    Intervention: Procedure: 5 cm colon-J-pouch
  • Arm III
    Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
    Intervention: Procedure: straight coloanal anastomosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
336
December 2015
May 2014   (final data collection date for primary outcome measure)
  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland,   Germany
 
NCT00238381
SAKK 40/04, EU-20528
Yes
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Study Chair: Christian T. Hamel, MD Kantonsspital - Abteilung Onkologie
Study Chair: Walter R. Marti, Prof. Kantonsspital Aarau
Study Chair: Markus Zuber, MD Kantonsspital Olten
Swiss Group for Clinical Cancer Research
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP