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A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

NCT01586741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-12-23

Study results available
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Summary

This is a three armed prospective randomized trial that will compare two different surgical techniques for reconstruction of the abdominal wall diastasis with a conservative treatment procedure.

The study hypothesis:

Which surgical approach provides the safest and best long term results for patients with abdominal wall diastasis either the insertion of net alternative with a double row suture or exercise alone?

Conditions

  • Abdominal Hernias and Other Abdominal Wall Conditions
  • Post-operative Pain
  • Recurrence

Interventions

PROCEDURE

Quill suture application for repair or polypropylene mesh

The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training

Sponsors & Collaborators

Principal Investigators

  • Ulf S Gunnarsson, professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-11-30
Completion
2012-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586741 on ClinicalTrials.gov