Status:
RECRUITING
Abdominal Rectus Diastasis (ARD) Reconstruction
Lead Sponsor:
Karolinska Institutet
Conditions:
Rectus Diastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to investigate whether abdominal wall reconstruction through laparoscopic surgery can be recommended as a safe treatment alternative for patients with symptomatic rectus diast...
Detailed Description
Investigate whether surgical reconstruction with laparoscopic technique can lead to improved quality of Life, trunk stability and reduced pain in patients with symptomatic rectus diastasis. The study ...
Eligibility Criteria
Inclusion Criteria:
- Rectus diastasis ≥3 cm
- BMI =<28 kg/m2
- non smoker
- abdominal instability,
- abdominal wall and/or lower back pain despite physical therapy / structured physical exercise for at least 6 months
Exclusion Criteria:
- BMI >28 kg/m2
- Smoking
- Ongoing immunosuppressive therapy
- Current pregnancy ≥16 weeks gestational age for the last 12 months
- Pregnant or women who wish to become pregnant
- Previously extensive abdominal wall surgery incl hernia surgery (NOT including sectio, appendectomy, small umbilical herniae)
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04182412
Start Date
June 17 2019
End Date
December 31 2027
Last Update
October 21 2024
Active Locations (1)
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1
Karolinska Institutet, Ersta Hospital
Stockholm, Region Stockholm, Sweden, SE-116 91