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

Not Applicable

Completed

• Conditions: Post-operative Pain; Abdominal Hernias and Other Abdominal Wall Conditions; Recurrence
• Interventions: Procedure: Quill suture application for repair or polypropylene mesh

• Registration Number: NCT01586741
• Lead Sponsor: Karolinska Institutet

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 Timeline

• Study Start: 2009-12
• Primary Completion: 2011-11
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-27
• Study Completion: 2012-12
• Status Verified: 2020-11
• Results First Submitted: 2020-11-25
• Results First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Results First Posted: 2020-12-23
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
quill suture	Quill suture application for repair or polypropylene mesh	Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.
Polypropylene mesh	Quill suture application for repair or polypropylene mesh	Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.

Primary Outcome Measures

Name	Time	Method
Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.	follow-up 1 year after surgery	All patients go through a CT scan and clinical examination one year after surgery

Secondary Outcome Measures

Name	Time	Method
Adverse Event Indicated in Case Report Formulary During the First 12 Months	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	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

Trial Locations

Locations (1)

Clintec, Karolinska Institutet; 🇸🇪 Stockholm, Sweden