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Completed

NCT Number: NCT01586559

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

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

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Key information

Conditions

Sex eligibility

Female

Study type

Observational

Primary location

Bulovka Hospital

Prague, 18 00, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women after rectus sheath plication for diastasis recti

Exclusion criteria

Abdominal wall defect other then umbilical hernia

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bulovka Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 27, 2012
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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