A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Abdominal wall diastasis> 3 cm
- •Discomfort or tenderness in the abdominal wall
- •Desire for abdominal wall reconstruction
- •Women have undergone at least one birth
- •Smoking cessation 1 month pre-and 3 months post-operatively
Exclusion Criteria
- •<18 years old
- •Ongoing pregnancy
- •Ongoing breastfeeding
- •Current immunosuppressive therapy
Arms & Interventions
Polypropylene mesh
Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.
Intervention: Quill suture application for repair or polypropylene mesh (Procedure)
quill suture
Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.
Intervention: Quill suture application for repair or polypropylene mesh (Procedure)
conservative treatment
Regular abdominal exercises workout for three months for 30 patients.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Adverse Event Indicated in Case Report Formulary During the First 12 Months(follow-up 1 year after surgery)
- Pain Post Operatively Measured by the VHPQ Questionnaires(follow-up 1 year after surgery)
Investigators
Peter Emanuelsson
MD, consultant in plastic surgery
Karolinska Institutet