Clinical Trial: A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Brief 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 Summary:
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.
Sponsor: Karolinska Institutet
Current Primary Outcome: Recurrence of diastasis one year post-operatively that indicated by CT scan or clinical investigation. [ Time Frame: follow-up 1 year after surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- adverse event indicated in case report formulary during the first 12 months [ Time Frame: follow-up 1 year after surgery ]adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection
- Pain post operatively measured by the VHPQ questionnaires [ Time Frame: follow-up 1 year after surgery ]
The validity and reliability of the VHPQ make it a useful tool in assessing postoperative pain and patient satisfaction.
PMID:
22446989 PubMed - as supplied by publisher
Original Secondary Outcome: Same as current
Information By: Karolinska Institutet
Dates:
Date Received: November 21, 2011
Date Started: December 2009
Date Completion: December 2012
Last Updated: April 25, 2012
Last Verified: April 2012