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

This study is ongoing, but not recruiting participants.
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
History of Changes
  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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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

ClinicalTrials.gov processed this record on June 18, 2013