Abdominal Rectus Diastasis (ARD) Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARD.
- Who it may be relevant to
- Registry conditions: Rectus Diastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis
Overview
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.
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 will also compare two different laparoscopic surgery methods for abdominal wall reconstruction: narrowing of linea alba with continuous suture with or without mesh.
Interventions
- Procedure ARD
surgical reconstruction with laparoscopic technique
Primary outcome measures
- Rate of recurrence [Time frame: 1 year]
Secondary outcome measures (4)
- Visual Analog Pain Scale (VAS) [Time frame: 1 year, 3 years]
- Abdominal stability [Time frame: 1 year, 3 years]
- SF-36 Quality of Life instrument [Time frame: 1 year, 3 years]
- VHPQ is a questionnaire for the assessment of pre- and postoperative pain [Time frame: 1 year, 3 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karolinska Institutet, Ersta Hospital — Stockholm
Identifiers
NCT: NCT04182412 · 2019-01959