Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
STOMAMESH
STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
1 other identifier
interventional
241
1 country
1
Brief Summary
Specific aim: To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery. All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh. If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2008
Longer than P75 for phase_2
1 active site
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
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 16, 2015
October 1, 2015
7.7 years
June 8, 2009
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of parastomal hernias in the two groups at 12 and 36 months postoperatively
At 12 and 36 months postoperatively
Secondary Outcomes (4)
Quality of life related to health
At 12 and 36 months postoperatively
The health care systems total cost related to the stoma
At 12 and 36 months postoperatively
Rate of infections 30 days postoperatively
At 30 days postoperatively
Late complication related to the mesh leading to surgery
At 12 and 36 months postoperatively
Study Arms (2)
Colostomy with a prophylactic mesh
EXPERIMENTALColostomy without a prophylactic mesh
NO INTERVENTIONInterventions
colostomy with a prophylactic hernia mesh
Eligibility Criteria
You may qualify if:
- Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively.
- No previous stoma.
- Over the age of 18.
- Informed consent signed by the patient.
You may not qualify if:
- Expected lifetime less then 3 years.
- Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
- Previous stoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunderby Hospital
Luleå, 97180, Sweden
Related Publications (1)
Naverlo S, Gunnarsson U, Strigard K, Nasvall P. Quality of life after end colostomy without mesh and with prophylactic synthetic mesh in sublay position: one-year results of the STOMAMESH trial. Int J Colorectal Dis. 2019 Sep;34(9):1591-1599. doi: 10.1007/s00384-019-03359-2. Epub 2019 Aug 7.
PMID: 31392405DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Dahlberg, MD PhD
Dept of Surgery Sunderby Hospital, Luela, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 11, 2009
Study Start
January 1, 2008
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 16, 2015
Record last verified: 2015-10