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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586741
• Other study ID #: 2009/227-31/3/PE/96
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Hernias and Other Abdominal Wall Conditions
• Hernia, Abdominal
• Pain, Postoperative
• Post-operative Pain
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Sweden	Clintec, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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