NCT04182412 Abdominal Rectus Diastasis (ARD) Reconstruction
| NCT ID | NCT04182412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Rectus Diastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2019-06-17 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2019-06-17 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Anders Thorell, Professor
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT04182412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectus Diastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04182412 currently recruiting?
Yes, NCT04182412 is actively recruiting participants. Contact the research team at anders.thorell@erstadiakoni.se for enrollment information.
Where is the NCT04182412 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT04182412 clinical trial?
NCT04182412 is sponsored by Karolinska Institutet. The principal investigator is Anders Thorell, Professor at Karolinska Institutet. The trial plans to enroll 110 participants.