Trial Concerning the Frequency of Parastomal Hernia With... | NCT00917995

Studies
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh

NCT00917995

Sponsor

Norrbottens Lans Landsting

Status

Completed

Last Update Posted

Oct 16, 2015Estimated

Enrollment

241Actual

Phase

Phase 2Phase 3

Conditions

Parastomal Hernia

Interventions

Polypropylene Mesh, density 25-40g/square meter

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jun 8, 2009

First Submission Date that Met QC Criteria

Jun 10, 2009

First Posted Date

Jun 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pia Nasvall, MD, PhD, Norrbottens Lans LandstingPrincipal Investigator

Lead Sponsor

Norrbottens Lans LandstingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

241Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colostomy with a prophylactic mesh	Experimental		Device: Polypropylene Mesh, density 25-40g/square meter
Colostomy without a prophylactic mesh	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polypropylene Mesh, density 25-40g/square meter	Device	colostomy with a prophylactic hernia mesh	Colostomy with a prophylactic mesh

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Dahlberg, MD PhD	Dept of Surgery Sunderby Hospital, Luela, Sweden	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunderby Hospital		Luleå		97180	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31392405	Derived	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.

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms