Clinical trial NCT04357171: PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection
Official title: Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: colostomy
ileostomy
rectal cancer
low anterior resection
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate.

This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.

Detailed description: Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence.

The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue.

The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity.

In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages.

Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.

Eligibility criteria: Inclusion Criteria:

* Mid- and low rectal cancer
* Age ≧ 18
* TME
* ASA ≦ 3
* No previous stoma formation
* Informed consent for participation

Exclusion Criteria:

* Patients lost during the follow-up
* Refusal of the patient from further participation in the study
* Inability of stoma formation

Primary outcomes:
measure: The rate of readmissions due to severe dehydratation
timeFrame: 6 weeks
Secondary outcomes:
measure: Early postoperative complications rate
timeFrame: 30 days after the initial procedure
measure: Late postoperative complications rate
timeFrame: starting on 31st day and within 6 months in late postoperative period after the initial procedure
measure: Overall quality of life
timeFrame: 6 and 12 months after the initial procedure
measure: Time with stoma
timeFrame: 5 years
measure: The rate of early postoperative complications after stoma closure operation
timeFrame: 3 months after stoma closure
Other outcomes:
Locations:
Study officials:
affiliation: Clinic of Colorectal and Minimally Invasive Surgery
name: Petr Tsarkov
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of Colorectal and Minimally Invasive Surgery
name: Inna Tulina
role: STUDY_CHAIR
References: