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NCT01586559 Clinical Trial

Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study

Diastasis Recti Clinical Trial

Official title:
Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01586559
Other study ID # IGANT11 392-6/2010-1
Secondary ID
Status Completed
Phase N/A
First received April 25, 2012
Last updated April 26, 2012
Start date October 2010
Est. completion date April 2012

Study information
Verified date April 2012
Source Bulovka Hospital
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Ethics Committee
Study type Observational

Clinical Trial Summary

A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.

Description:

Background: Rectus sheath plication within abdominoplasty is a standard treatment for diastasis of the recti muscles. Previous studies assessing the efficacy and endurance of the correction of recti diastasis have mostly been performed with small groups of patients, short follow-up periods and/or with questionable methodology

Methods: A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture. The investigators assess the outcomes by physical and ultrasonographic examinations and a patient questionnaire, which asks about the number of pregnancies and the types of deliveries, other abdominal surgeries before or after the abdominoplasty, the interval of time required to return to full activity, postoperative pain, and the overall satisfaction with the final result. During the examination, the inter-recti distances are measured at 3 levels: halfway between the xyphoid and umbilicus, just above the umbilicus and halfway between the umbilicus and pubis. The same examination is done on a control group of nulliparous women.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date April 2012
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

Women after rectus sheath plication for diastasis recti

Exclusion Criteria:

Abdominal wall defect other then umbilical hernia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Czech Republic Bulovka Hospital Prague 8

Sponsors (1)
Lead Sponsor Collaborator
Bulovka Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the long-term stability of sheath plication using absorbable sutures in patients with diastasis of the recti muscles 12-41 months No
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