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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01586741
Other study ID # 2009/227-31/3/PE/96
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2009
Est. completion date December 2012

Study information

Verified date November 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date December 2012
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Clintec, Karolinska Institutet Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 follow-up 1 year after surgery
Secondary 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 follow-up 1 year after surgery
Secondary 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
follow-up 1 year after surgery
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