Overview

This trial is active, not recruiting.

Conditions abdominal hernias and other abdominal wall conditions, post-operative pain, recurrence
Treatment quill suture application for repair or polypropylene mesh
Sponsor Karolinska Institutet
Start date December 2009
End date November 2011
Trial size 96 participants
Trial identifier NCT01586741, 2009/227-31/3/PE/96

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.
quill suture application for repair or polypropylene mesh Quill suture
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
(Active Comparator)
Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.
quill suture application for repair or polypropylene mesh Quill suture
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
(No Intervention)
Regular abdominal exercises workout for three months for 30 patients.
quill suture application for repair or polypropylene mesh Quill suture
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training

Primary Outcomes

Measure
Recurrence of diastasis one year post-operatively that indicated by CT scan or clinical investigation.
time frame: follow-up 1 year after surgery

Secondary Outcomes

Measure
adverse event indicated in case report formulary during the first 12 months
time frame: follow-up 1 year after surgery
Pain post operatively measured by the VHPQ questionnaires
time frame: follow-up 1 year after surgery

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Abdominal wall diastasis> 3 cm 2. Discomfort or tenderness in the abdominal wall 3. Desire for abdominal wall reconstruction 4. Women have undergone at least one birth 5. Smoking cessation 1 month pre-and 3 months post-operatively Exclusion Criteria: 1. <18 years old 2. Ongoing pregnancy 3. Ongoing breastfeeding 4. Current immunosuppressive therapy

Additional Information

Official title A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Karolinska Institutet.