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

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

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?

Study Overview

• Status: Completed
• Conditions: Recurrence; Post-operative Pain; Abdominal Hernias and Other Abdominal Wall Conditions
• Intervention / Treatment: Procedure: Quill suture application for repair or polypropylene mesh

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • CLINTEC, Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Polypropylene mesh; Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.	Procedure: Quill suture application for repair or polypropylene mesh; The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training; Other Names: Quill suture; And Soft mesh Polypropylene mesh
Active Comparator: quill suture; Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.	Procedure: Quill suture application for repair or polypropylene mesh; The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training; Other Names: Quill suture; And Soft mesh Polypropylene mesh
No Intervention: conservative treatment; Regular abdominal exercises workout for three months for 30 patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	follow-up 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	follow-up 1 year after surgery

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Director: Ulf S Gunnarsson, professor, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (Estimate): April 27, 2012

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease Attributes; Pathological Conditions, Anatomical; Hernia; Pain, Postoperative; Recurrence; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: 2009/227-31/3/PE/96