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 ]

All patients go through a CT scan and clinical examination one 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