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

Russian Society of Colorectal Surgeons

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Low anterior resection with protective loop transverse colostomy; Procedure: Low anterior resection with protective loop ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04357171

5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups

Ileostomy

Active Comparator group

Description:

Loop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection

Treatment:

Procedure: Low anterior resection with protective loop ileostomy

Colostomy

Active Comparator group

Description:

Loop protective transverse colostomy as a defunction mean after low anterior resection with D3 lymphnode dissection

Treatment:

Procedure: Low anterior resection with protective loop transverse colostomy