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

Colorectal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238381
• Other study ID #: SAKK 40/04
• Secondary ID: EU-20528
• Status: Completed
• Phase: Phase 3
• Start date: July 2005
• Est. completion date: August 2016

Study information

• Verified date: May 2019
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: August 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• 5 cm colon-J-pouch
5 cm colon-J-pouch with/without temporary protective ileostomy
• side-to-end anastomosis
side-to-end anastomosis with/without temporary protective ileostomy
• straight coloanal anastomosis
straight coloanal anastomosis with/without temporary protective ileostomy

Locations

Country	Name	City	State
Germany	Kreiskrankenhaus Lörrach	Lörrach
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Zuger Kantonsspital AG	Baar
Switzerland	Universitaetsspital-Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Kantonsspital Bruderholz	Bruderholz
Switzerland	Bezirksspital Dornach	Dornach
Switzerland	Hopitaux Universitaires de Geneve	Geneva
Switzerland	Hopital de La Chaux-de-Fonds	La Chaux-de-Fonds
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Kantonsspital Luzern	Luzerne
Switzerland	Ospedale Beata Vergine	Mendrisio
Switzerland	Kantonsspital Olten	Olten
Switzerland	GZO Spital Wetzikon	Wetzikon
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	City Hospital Triemli	Zurich
Switzerland	Klinik Hirslanden	Zurich
Switzerland	UniversitaetsSpital Zuerich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Marti WR, Curti G, Wehrli H, Grieder F, Graf M, Gloor B, Zuber M, Demartines N, Fasolini F, Lerf B, Kettelhack C, Andrieu C, Bigler M, Hayoz S, Ribi K, Hamel C; Swiss Group for Clinical Cancer Research (SAKK), Section Surgery. Clinical Outcome After Recta — View Citation

Outcome

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