Abdominal Rectus Diastasis (ARD) Reconstruction
Launched by KAROLINSKA INSTITUTET · Nov 28, 2019
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a surgical procedure called laparoscopic reconstruction for a condition known as rectus diastasis, which is when the abdominal muscles separate and can cause discomfort and instability. The goal is to find out if this type of surgery is safe and if it helps improve patients' quality of life, reduces pain, and makes their core muscles stronger.
To be eligible for the trial, participants should be between 65 to 74 years old, have a separation of the abdominal muscles of at least 3 cm, and a body mass index (BMI) of 28 or lower. They should also be non-smokers and have experienced abdominal or lower back pain that hasn't improved with physical therapy for at least six months. If you join the study, you will undergo the laparoscopic surgery and then be monitored to see how it affects your symptoms and overall health. It's important to know that individuals with certain health conditions or those who are pregnant may not be able to participate.
Gender
ALL
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)
About Karolinska Institutet
Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, Region Stockholm, Sweden
Patients applied
Trial Officials
Anders Thorell, Professor
Principal Investigator
Karolinska Institutet
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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