Diastasis Recti Clinical Trial
— RmBOfficial title:
Operative Correction of Abdominal Rectus Diastasis (ARD): the Effect on Low Back Pain and Movement Control. A Randomized, Prospective Trial Comparing Novel, Mini-invasive Mesh Repair to Plication
This study is a randomized controlled trial comparing two ADR repair methods: nylon suturing and nylon suture with mesh enforcement. The ADR correction is performed simultaneously with abdominoplasty/ modified skin reduction abdominoplasty.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Symptomatic diastasis recti (> 3 cm) after pregnancies, with or without a midline hernia Exclusion Criteria: - BMI > 28, - smoking - less than a year since the previous pregnancy or still breast feeding - planning further pregnancies |
Country | Name | City | State |
---|---|---|---|
Finland | HUCH Jorvi Hospital, department of Surgery | Espoo | |
Finland | Oulu University Hospital | Oulu |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Oulu University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low back pain | Improvement in Oswestry 2.0 score | At one year | |
Secondary | Recurrence | Number of symptomatic, recurrent diastasis > 3 cm | at 1 year | |
Secondary | Quality of life | RAND 36 questionnaire | at one year |
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