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Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04182412

Laparoscopic Abdominal Wall Reconstruction for Symptomatic Rectus Diastasis Comparing Two Surgical Methods

Led by Karolinska Institutet · Updated on 2024-10-21

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with symptomatic rectus diastasis, a condition where the abdominal muscles separate, causing pain and instability. The trial aims to evaluate if laparoscopic abdominal wall reconstruction is a safe treatment option and whether it improves quality of life, trunk stability, and reduces pain. The study also compares two laparoscopic methods suturing the linea alba alone or with added mesh. Participants will undergo one of two surgical procedures for abdominal wall reconstruction either narrowing the linea alba using continuous sutures alone or using continuous sutures combined with mesh. Both methods are performed laparoscopically, and the study uses a randomized, double-blind design to compare their outcomes. During the study, participants will be monitored for recurrence of rectus diastasis over one year. Pain levels will be assessed using the Visual Analog Pain Scale, and questionnaires like SF-36 and VHPQ will evaluate quality of life and pain before and after surgery at 1 and 3 years. Abdominal stability will also be measured to understand the surgerys impact. The total duration of participation may extend up to 3 years for follow-up assessments.

CONDITIONS

Brief Title

Abdominal Rectus Diastasis (ARD) Reconstruction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Rectus diastasis 3 cm or larger
  • Body mass index (BMI) of 28 kg/m2 or less
  • Non-smoker
  • Abdominal instability
  • Abdominal wall and/or lower back pain despite physical therapy or structured exercise for at least 6 months
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) greater than 28 kg/m2
  • Current smoker
  • Ongoing immunosuppressive therapy
  • Pregnancy of 16 weeks gestational age or more within the last 12 months
  • Currently pregnant or wishing to become pregnant
  • Previous extensive abdominal wall surgery including hernia surgery (except cesarean section, appendectomy, small umbilical hernias)

Research Team

A

Anders Thorell, Professor

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