NCT01694238

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

September 24, 2012

Last Update Submit

March 27, 2019

Conditions

ColostomyColorectal NeoplasmDiverticulitis

Keywords

ColostomySurgical technique

Outcome Measures

Primary Outcomes (1)

  • Stoma hernia frequency at 12 months

    The frequency of stoma hernia at 12 months measured either by clinical examination or CT scan

    12 months

Secondary Outcomes (5)

  • Readmission

    12 months

  • Postoperative infections

    12 months

  • Total hospital stay

    12 months

  • Other complications

    12 months

  • 30 day mortality

    30 days

Study Arms (3)

Cruciate incision

ACTIVE COMPARATOR

Cruciate incision in the abdominal wall fascia

Procedure: Cruciate incision

Circular incision

EXPERIMENTAL

Circular incision in the fascia

Procedure: Circular incision

Mesh enforced cruciate incision

EXPERIMENTAL

Mesh enforcement and then cruciate incision in the abdominal wall fascia

Other: Mesh enforced cruciate incision

Interventions

Cruciate incisionPROCEDURE
Cruciate incision
Circular incisionPROCEDURE
Circular incision
Mesh enforced cruciate incisionOTHER
Mesh enforced cruciate incision

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital/östra

Gothenburg, 41685, Sweden

Location

Related Publications (1)

  • 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 Jun 27;15:254. doi: 10.1186/1745-6215-15-254.

    PMID: 24970570DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsDiverticulitis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDiverticular DiseasesGastroenteritis

Study Officials

  • Eva Angenete, M.D., Ph.D.

    Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University and SSORG - Scandinavian Surgical Outcomes Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D., senior consultant surgeon

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

June 1, 2013

Primary Completion

September 1, 2017

Study Completion

October 1, 2018

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

SE(1)