CompletedPhase 3

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

Germany, Switzerland336 participantsStarted 2005-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite evacuation score after total mesorectal excision

Timeframe: 12 months after surgery

Trial details

NCT IDNCT00238381

SponsorSwiss Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05

View on ClinicalTrials.gov More Colorectal Cancer trials