PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Low anterior resection with protective loop ileostomy
* Procedure: Low anterior resection with protective loop transverse colostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ileostomy<br>Loop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection | Procedure: Low anterior resection with protective loop ileostomy<br>* Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed.<br>|
| Active Comparator: Colostomy<br>Loop protective transverse colostomy as a defunction mean after low anterior resection with D3 lymphnode dissection | Procedure: Low anterior resection with protective loop transverse colostomy<br>* Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of readmissions due to severe dehydratation | The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early postoperative complications rate | The rate of all postoperative complications in early postoperative period after resectional surgery | 30 days after the initial procedure | 
| Late postoperative complications rate | The rate of all postoperative complications | starting on 31st day and within 6 months in late postoperative period after the initial procedure | 
| Overall quality of life | Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability | 6 and 12 months after the initial procedure | 
| Time with stoma | The period of time between initial resectional procedure and closure of protetctive stoma only in patients who had their intestinal stoma reversed | 5 years | 
| The rate of early postoperative complications after stoma closure operation | The rate of early postoperative complications after stoma closure operation | 3 months after stoma closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colostomy, ileostomy, rectal cancer, low anterior resection