THE STOMA-CONST TRIAL: A STOMA CONSTRUCTION STUDY

 

The present study will compare circular, cruciate incision and cruciate incision with reinforcement with prophylactic mesh in sublay position at the fascia during stoma formation surgery. The design involves all consecutive patients with an elective/planned operation including a end-colostomy construction.

Hypothesis

It is possible to obtain a lower parastomal hernia incidence with a circular incision in the abdominal fascia or reinforcement of a mesh instead of a cruciate incision in the abdominal fascia.

End-points

Primary:

Parastomal hernia 12 months postoperatively, for all patients in each group. Sub-group analysis planned for patients with BMI>30 and for patients with immunosuppression.

 Secondary:

-       Re-admission, Postoperative infections- wound or deep infection (abscess formation), postoperative thrombosis, stoma related complications, other complications, bowel obstruction- requiring hospitalisation or operation, total length of hospital stay during 12 months, quality of life, health economic analysis, re-operation 30 days, mortality within 30 days of primary operation, mortality within 12 months, re-admissions and re-operations registered in including hospital database at 24 
months.

Inclusion/exclusion

Inclusion criteria:

Patients are eligible if the following conditions are met:

-       Presenting with a cancer or another condition for which an elective surgical procedure is planned that includes formation of a end-colostomy

-       Possible to operate in regard to concomitant disease

-       Giving informed consent to participate

Exclusion criterium:

Participation in other randomized trials in conflict with the protocol and end- points of the Stoma-Const trial.

Inclusion of patients:

Aiming at including 240 patients (120 in each group).

Participating hospitals

Herlev Hospital and Sahlgrenska Universitetssjukhuset

Documents

Protocol (click name to download): Stoma-const

Publication:

-       Correa Marinez A, Erestam S, Haglind E, Ekelund J, Angeras U, Rosenberg J, Helgstrand F, Angenete E: Stoma-Const - the technical aspects of stoma construction: study protocol for a randomised controlled trial. Trials 2014;15:254.

Contact

Principal investigator:

Eva Angenete

Deputy principal investigator:

Eva Haglind and Ulf Angerås

Questions:

Doctoral student Adiela Correa Marinez (adiela-adriana.correa-marinez@vgregion.se), research nurse Sofia Erestam (sofia.erestam@vgregion.se) or research nurse Elin Grybäck (elin.grybäck@vgregion.se)