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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Karolinska Institutet.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Peter Emanuelsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01586741
First received: November 21, 2011
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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?


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Recurrence of diastasis one year post-operatively that indicated by CT scan or clinical investigation. [ Time Frame: follow-up 1 year after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: follow-up 1 year after surgery ] [ Designated as safety issue: Yes ]
    adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection

  • Pain post operatively measured by the VHPQ questionnaires [ Time Frame: follow-up 1 year after surgery ] [ Designated as safety issue: No ]

    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



Enrollment: 96
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586741

Locations
Sweden
Clintec, Karolinska Institutet
Stocholm, Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Director: Ulf S Gunnarsson, professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Peter Emanuelsson, MD, consultant in plastic surgery, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01586741     History of Changes
Other Study ID Numbers: 2009/227-31/3/PE/96
Study First Received: November 21, 2011
Last Updated: April 25, 2012
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Recurrence
Pain, Postoperative
Hernia, Abdominal
Disease Attributes
Pathologic Processes
Postoperative Complications
Pain
Signs and Symptoms
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014