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Evaluating personalized use of defunctioning stoma after rectal cancer surgery

A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer

Not applicable Interventional University Hospital, Bordeaux · NCT05233787

This study is testing whether a personalized approach to using a temporary stoma after rectal cancer surgery can improve patients' quality of life and recovery compared to a standard method.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment212 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorUniversity Hospital, Bordeaux Academic / other
Locations28 sites (Amiens and 27 other locations)
Trial IDNCT05233787 on ClinicalTrials.gov

What this trial studies

This trial aims to compare the tailored versus systematic use of defunctioning stoma after Total Mesorectal Excision (TME) for rectal cancer. It will assess the impact of a personalized approach based on the risk of anastomotic leakage on patients' quality of life and functional outcomes over 12 months post-surgery. The study will involve a two-step process for the experimental group, determining the necessity of a stoma and the timing of its closure. The goal is to reduce complications and improve patient outcomes while potentially lowering healthcare costs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with rectal adenocarcinoma located less than 12 cm from the anal verge, who are undergoing mini-invasive TME.

Not a fit: Patients with metastatic rectal cancer or those not eligible for TME may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life and functional outcomes for patients undergoing rectal cancer surgery.

How similar studies have performed: While the tailored approach is novel, previous studies have indicated that personalized strategies may lead to better functional outcomes compared to standard practices.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age 18-80 years;
* Rectal adenocarcinoma (histologically proven)
* No metastasis or medical history of colorectal metastasis (M0)
* Patients with rectal cancer \< 12 cm from the anal verge (determined by rectal examination or MRI)
* Patients operated on by mini-invasive TME (laparoscopic, robotic or TaTME);
* With or without neo adjuvant treatment
* Realize a stapling anastomosis \< 7 cm from the anal verge (determined by rectal examination or MRI)
* Patients with expected defunctioning ileostomy
* Appropriate hematologic function: hemoglobin ≥ 10.5 g/dL, leukocytes \> 4000/mm3, blood platelets \> 100,000/mm3);
* Appropriate renal function (serum creatinine \< 15 mg/dL);
* Effective contraception of childbearing age : Male patients and premenopausal women should agree to use two medically validated contraceptive methods (one for the patient et one for the partner) during the study
* Patient affiliated or beneficiary to a health security system;
* Patient and doctor have signed informed consent

Exclusion Criteria:

* Patients with rectal cancer requiring TME surgery with handsewn anastomosis;
* Patients operated on by open approach;
* Previous pelvic irradiation for reasons other than rectal cancer
* Concomitant cancer or medical history of cancer within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)
* Patients with expected defunctioning colostomy;
* Patients with perforated rectal cancer or preoperative pelvic sepsis;
* Patients with inflammatory bowel disease and/or bowel obstruction,
* Patients operated on in emergency;
* Patients with poor nutrition (Albumin \< 34 g/L, pre-Alb \< 0.14 g/L)
* Patients with extended-TME or pelvic exenteration (prostate);
* Patients with history of heart or vascular ischemia;
* Severe heart disease or congestive heart disease;
* Patients with immunodeficiency and/or under corticotherapy;
* Severe lung disease or respiratory failure;
* Severe kidney disease;
* Previous disease or disability expected to influence the assessment of postoperative QOL;
* Pregnancy or breast feeding;
* Persons deprived of liberty or under guardianship (curatorship or tutorship) or incapable of giving consent;
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up scheduled.

Where this trial is running

Amiens and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rectal CancerIleostomyFunctional DisturbanceDefunctioning stomaQuality of lifePelvic sepsisFunctional outcomes
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.