ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01586741
Recruitment Status : Unknown
Verified April 2012 by Peter Emanuelsson, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2012
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Peter Emanuelsson, Karolinska Institutet

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?


Condition or disease Intervention/treatment Phase
Abdominal Hernias and Other Abdominal Wall Conditions Post-operative Pain Recurrence Procedure: Quill suture application for repair or polypropylene mesh Not Applicable

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  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Study Start Date : December 2009
Actual Primary Completion Date : November 2011
Estimated Study Completion Date : December 2012

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.
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




Primary Outcome Measures :
  1. Recurrence of diastasis one year post-operatively that indicated by CT scan or clinical investigation. [ Time Frame: follow-up 1 year after surgery ]
    All patients go through a CT scan and clinical examination one year after surgery


Secondary Outcome Measures :
  1. adverse event indicated in case report formulary during the first 12 months [ Time Frame: follow-up 1 year after surgery ]
    adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection

  2. Pain post operatively measured by the VHPQ questionnaires [ Time Frame: follow-up 1 year after surgery ]

    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




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586741


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

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