Clinical trial NCT01586741: A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Official title: A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Hernias and Other Abdominal Wall Conditions
Post-operative Pain
Recurrence
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.
timeFrame: follow-up 1 year after surgery
Secondary outcomes:
measure: Adverse Event Indicated in Case Report Formulary During the First 12 Months
timeFrame: follow-up 1 year after surgery
measure: Pain Post Operatively Measured by the VHPQ Questionnaires
timeFrame: follow-up 1 year after surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Clintec, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Ulf S Gunnarsson, professor
role: STUDY_DIRECTOR
References:
citation: Emanuelsson P, Gunnarsson U, Strigard K, Stark B. Early complications, pain, and quality of life after reconstructive surgery for abdominal rectus muscle diastasis: a 3-month follow-up. J Plast Reconstr Aesthet Surg. 2014 Aug;67(8):1082-8. doi: 10.1016/j.bjps.2014.04.015. Epub 2014 May 2.