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Abdominal Rectus Diastasis (ARD) Reconstruction

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Karolinska Institute

Status

Enrolling

Conditions

Rectus Diastasis

Treatments

Procedure: ARD

Study type

Interventional

Funder types

Other

Identifiers

NCT04182412
2019-01959

Details and patient eligibility

About

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 diastasis, and if this type of treatment leads to improved quality of life, trunk stability and reduced pain.

Full 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 will also compare two different laparoscopic surgery methods for abdominal wall reconstruction: narrowing of linea alba with continuous suture with or without mesh.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

110 participants in 2 patient groups

Suture
Active Comparator group
Description:
laparoscopic narrowing of linea alba with continuous suture
Treatment:
Procedure: ARD
suture and mesh
Active Comparator group
Description:
narrowing of linea alba with continuous suture and mesh
Treatment:
Procedure: ARD

Trial contacts and locations

1

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Central trial contact

Anders Thorell, Professor

Data sourced from clinicaltrials.gov

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