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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
Clintec, Karolinska Institutet
Stockholm, Sweden
Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.
All patients go through a CT scan and clinical examination one year after surgery
Time frame: follow-up 1 year after surgery
Adverse Event Indicated in Case Report Formulary During the First 12 Months
adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection
Time frame: follow-up 1 year after surgery
Pain Post Operatively Measured by the VHPQ Questionnaires
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
Time frame: follow-up 1 year after surgery
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