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

April 26, 2012 updated by: Ondrej Mestak M.D., Bulovka Hospital
A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with interval after rectus sheath plication

Description

Inclusion Criteria:

Women after rectus sheath plication for diastasis recti

Exclusion Criteria:

Abdominal wall defect other then umbilical hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Nulliparous women
Diastasis
Patients after rectus sheath plication due to diastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the long-term stability of sheath plication using absorbable sutures in patients with diastasis of the recti muscles
Time Frame: 12-41 months
12-41 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bulovka Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (ESTIMATE)

April 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • IGANT11 392-6/2010-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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