Back to results

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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Quill suture application for repair or polypropylene mesh

About this trial

This is an interventional treatment trial for Abdominal Hernias and Other Abdominal Wall Conditions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Abdominal wall diastasis> 3 cm
Discomfort or tenderness in the abdominal wall
Desire for abdominal wall reconstruction
Women have undergone at least one birth
Smoking cessation 1 month pre-and 3 months post-operatively

Exclusion Criteria:

<18 years old
Ongoing pregnancy
Ongoing breastfeeding
Current immunosuppressive therapy

Sites / Locations

Clintec, Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Polypropylene mesh

quill suture

conservative treatment

Arm Description

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

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

Regular abdominal exercises workout for three months for 30 patients.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01586741

First Posted

November 21, 2011

Last Updated

November 25, 2020

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01586741

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

December 2009 (Actual)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Polypropylene mesh

Arm Type

Active Comparator

Arm Description

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

Arm Title

quill suture

Arm Type

Active Comparator

Arm Description

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

Arm Title

conservative treatment

Arm Type

No Intervention

Arm Description

Regular abdominal exercises workout for three months for 30 patients.

Intervention Type

Procedure

Intervention Name(s)

Quill suture application for repair or polypropylene mesh

Other Intervention Name(s)

Quill suture, And Soft mesh Polypropylene mesh

Intervention Description

The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training

Primary Outcome Measure Information:

Title

Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.

Description

All patients go through a CT scan and clinical examination one year after surgery

Time Frame

follow-up 1 year after surgery

Secondary Outcome Measure Information:

Title

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

Description

adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection

Time Frame

follow-up 1 year after surgery

Title

Pain Post Operatively Measured by the VHPQ Questionnaires

Description

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

Time Frame

follow-up 1 year after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Abdominal wall diastasis> 3 cm Discomfort or tenderness in the abdominal wall Desire for abdominal wall reconstruction Women have undergone at least one birth Smoking cessation 1 month pre-and 3 months post-operatively Exclusion Criteria: <18 years old Ongoing pregnancy Ongoing breastfeeding Current immunosuppressive therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulf S Gunnarsson, professor

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Director

Facility Information:

Facility Name

Clintec, Karolinska Institutet

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

24880577

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs