PROtective ileoStomy versus ProtectivE colostomy in anterior Rectal resectIon: study protocol for a multicenter,...

Area of Science:

• Colorectal surgery
• Surgical oncology
• Gastroenterology

Background:

• Loop ileostomy and loop colostomy are utilized as protective stomas following anterior resection surgery.
• There is a lack of evidence comparing the superiority of these two stoma types.
• No studies have investigated the impact of loop ileostomy versus loop colostomy on the gut microbiome.

Purpose of the Study:

• To compare the efficacy and complications of loop ileostomy versus loop colostomy in patients undergoing anterior rectal resection.
• To evaluate the impact of these stoma types on patient quality of life and kidney function.
• To explore potential differences in microbiome composition between loop ileostomy and loop colostomy patients.

Main Methods:

• A multicenter, open-label, superiority, individually randomized controlled trial involving 350 patients undergoing anterior rectal resection.
• Patients are randomized 1:1 to either loop ileostomy or loop colostomy.
• Primary outcome is cumulative stoma-related adverse events within 60 days (Comprehensive Complication Index); secondary and tertiary outcomes include overall complications, quality of life, kidney function, survival, and hernia rates.

Main Results:

• This section is to be filled once the study is completed and results are available.

Conclusions:

• This section is to be filled once the study is completed and results are available.