Clinical trial · Interventional
A Randomized Trial on the Technical Aspects of Stoma Construction.
Circular, Mesh Enforced or Cruciate Incision in the Abdominal Wall Fascia for coloStomy Construction - A Randomised Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting colostomy for any reason are all included. The three groups for randomization are: A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is the parastomal hernia rate within 12 months from index surgery. Secondary end-points include clinical variables, re-admission and/or re-operation due to any stoma complication, quality of life and health economy analyses, at 12 months.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colostomy | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circular incision | Procedure | — | UNRESOLVED |
| Cruciate incision | Procedure | — | UNRESOLVED |
| Mesh enforced cruciate incision | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Cruciate incision
- description
- Cruciate incision in the abdominal wall fascia
- interventionNames
- Procedure: Cruciate incision
- type
- EXPERIMENTAL
- label
- Circular incision
- description
- Circular incision in the fascia
- interventionNames
- Procedure: Circular incision
- type
- EXPERIMENTAL
- label
- Mesh enforced cruciate incision
- description
- Mesh enforcement and then cruciate incision in the abdominal wall fascia
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * presenting with a cancer or other conditions for which an elective surgical procedure is planned and includes a permanent colostomy formation * possible to operate in regard to concomitant disease * giving informed consent to participate Exclusion Criteria: * Not possible to operate due to concomitant disease * Participation in other randomized trials in conflict with the protocol and end-points of the Stoma-Const trial.
References
Publications (1)
- DERIVEDCorrea 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 Jun 27;15:254. doi: 10.1186/1745-6215-15-254. PMID 24970570