Stoma-Const--the technical aspects of stoma construction: study protocol for a randomised controlled trial

Area of Science:

• Colorectal surgery
• Surgical innovation
• Hernia prevention

Background:

• Colostomy construction is common, but evidence supporting specific techniques is limited.
• Parastomal hernia is a frequent complication following colostomy formation.
• Existing studies lack conclusive data on quality of life and health economics related to parastomal hernias.

Purpose of the Study:

• To standardize colostomy formation techniques.
• To compare three colostomy formation methods, including one with mesh, for their impact on parastomal hernia development.
• To evaluate patient-reported outcomes, clinical assessments, and radiological findings.

Main Methods:

• A Scandinavian randomized trial (Stoma-Const) involving 240 patients.
• Comparison of three colostomy formation types, with one incorporating a mesh.
• Primary endpoint: parastomal herniation assessed via clinical examination or CT scan within one year.
• Secondary endpoints include re-admission rates, complication rates (Clavien-Dindo), stoma-related issues, hospital stay, quality of life, and health economics.

Main Results:

• Data on main results are not yet available in the abstract.
• The study is ongoing with a planned inclusion of 240 patients.
• Follow-up assessments are scheduled at 4-6 weeks, 6 months, and 12 months post-surgery.

Conclusions:

• Parastomal hernia remains a significant challenge after colostomy.
• There is a need for conclusive evidence on effective prevention strategies.
• This study aims to provide data on standardized techniques, patient outcomes, and health economics to address this complication.