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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

Tracking Information
First Submitted Date  ICMJE November 21, 2011
First Posted Date  ICMJE April 27, 2012
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE December 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Official Title  ICMJE A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Abdominal Hernias and Other Abdominal Wall Conditions
  • Post-operative Pain
  • Recurrence
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Polypropylene mesh
    Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.
    Intervention: Procedure: Quill suture application for repair or polypropylene mesh
  • Active Comparator: quill suture
    Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.
    Intervention: Procedure: Quill suture application for repair or polypropylene mesh
  • No Intervention: conservative treatment
    Regular abdominal exercises workout for three months for 30 patients.
    Intervention: Procedure: Quill suture application for repair or polypropylene mesh
Publications * Emanuelsson P, Gunnarsson U, Strigård 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 25, 2012)
96
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01586741
Other Study ID Numbers  ICMJE 2009/227-31/3/PE/96
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Emanuelsson, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ulf S Gunnarsson, professor Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP