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

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.

Study Overview

• Status: Completed
• Conditions: Parastomal Hernia
• Intervention / Treatment: Device: Polypropylene Mesh, density 25-40g/square meter

Detailed Description

Parastomal hernia is a relatively common and troublesome complication in patients with a stoma. The exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. A parastomal hernia may give the patient difficulties with appliance and leakage. From an economical point of view a stoma that requires special kinds of appliances is expensive. Theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. Recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. No negative side effects with the use of a mesh have been reported in these studies. All earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. Complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. To understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial.

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.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Lulea, Sweden, 97180
    • Sunderby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Expected lifetime less then 3 years.
• Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
• Previous stoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colostomy with a prophylactic mesh	Device: Polypropylene Mesh, density 25-40g/square meter; colostomy with a prophylactic hernia mesh
No Intervention: Colostomy without a prophylactic mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of parastomal hernias in the two groups at 12 and 36 months postoperatively	At 12 and 36 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Norrbottens Lans Landsting
• Investigators: Study Chair: Michael Dahlberg, MD PhD, Dept of Surgery Sunderby Hospital, Luela, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: hernia; colostomy; parastomal hernia; prophylactic mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 07-081M