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Search / Trial NCT04182412

Abdominal Rectus Diastasis (ARD) Reconstruction

Launched by KAROLINSKA INSTITUTET · Nov 28, 2019

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Laparoscopy Mesh Reinforcement Abdominal Stability

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.

Locations

Stockholm, Region Stockholm, Sweden

Patients applied

0 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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