PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection (PROTECT)

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Low anterior resection with protective loop ileostomy; Procedure: Low anterior resection with protective loop transverse 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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ileostomy; Loop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection	Procedure: Low anterior resection with protective loop ileostomy; 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.
Active Comparator: Colostomy; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Investigators: Principal Investigator: Petr Tsarkov, Clinic of Colorectal and Minimally Invasive Surgery; Study Chair: Inna Tulina, Clinic of Colorectal and Minimally Invasive Surgery

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2012
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): February 2, 2020

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: ileostomy; rectal cancer; colostomy; low anterior resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No