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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: 5 cm colon-J-pouch
* Procedure: side-to-end anastomosis
* Procedure: straight coloanal anastomosis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm I<br>Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction. | Procedure: side-to-end anastomosis<br>* side-to-end anastomosis with/without temporary protective ileostomy<br>|
| Other: Arm II<br>Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction. | Procedure: 5 cm colon-J-pouch<br>* 5 cm colon-J-pouch with/without temporary protective ileostomy<br>|
| Other: Arm III<br>Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy | Procedure: straight coloanal anastomosis<br>* straight coloanal anastomosis with/without temporary protective ileostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite evacuation score after total mesorectal excision |  | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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