A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

Karolinska Institute

Status: Completed

Conditions: Post-operative Pain; Abdominal Hernias and Other Abdominal Wall Conditions; Recurrence

Treatments: Procedure: Quill suture application for repair or polypropylene mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT01586741

2009/227-31/3/PE/96

Details and patient eligibility

About

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?

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 3 patient groups

Polypropylene mesh

Active Comparator group

Description:

Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.

Treatment:

Procedure: Quill suture application for repair or polypropylene mesh

quill suture

Active Comparator group

Description:

Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.

Treatment:

Procedure: Quill suture application for repair or polypropylene mesh

conservative treatment

No Intervention group

Description:

Regular abdominal exercises workout for three months for 30 patients.