NCT01586741

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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?

Detailed description

The conservative control group will receive a special training program for abdominal muscle training for 3 months,and all groups wearing girdle for 3 months. All patients examined with a CT scan before randomization and then a Biodex measurement of abdominal muscle strength. All patients must also complete the SF-36 (scientifically tested instruments to measure self-reported physical and mental health) and VHPQ (ventral hernia Pain Questionnaire). Two-thirds of patients receive surgery and followed up with a 3 month and 1-year control.At 1 year of control, all go through a CT scan and a Biodex measurement of muscle strength. The control group followed up after one and half months and 3 months. In the surgery group, patients may not know what reconstruction they received before the final assessment after 1 year.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-11-01
• Completion: 2012-12-01
• First posted: 2012-04-27
• Last updated: 2020-12-23
• Results posted: 2020-12-23

Locations

1 site across 1 country: Sweden