Laparoscopic surgery for abdominal wall reconstruction in patients with rectus diastasis
Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis
This study is testing if a new type of laparoscopic surgery can help people with rectus diastasis feel better and improve their quality of life by comparing two different surgical techniques.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Region Stockholm) |
| Trial ID | NCT04182412 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of laparoscopic surgery for reconstructing the abdominal wall in patients suffering from symptomatic rectus diastasis. It aims to determine if this surgical approach can enhance quality of life, improve trunk stability, and alleviate pain. The study will compare two laparoscopic techniques: one involving continuous suturing of the linea alba with mesh reinforcement and the other without mesh. Participants will be monitored for improvements in their symptoms and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are individuals with rectus diastasis of 3 cm or more, a BMI of 28 or less, and who have not found relief from physical therapy.
Not a fit: Patients with a BMI over 28, those who smoke, or individuals with a history of extensive abdominal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with rectus diastasis by reducing pain and enhancing abdominal stability.
How similar studies have performed: Other studies have shown promising results with laparoscopic approaches for abdominal wall reconstruction, indicating potential success for this method.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Stockholm, Region Stockholm
- Karolinska Institutet, Ersta Hospital — Stockholm, Region Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Anders Thorell, Professor — Karolinska Institutet
- Study coordinator: Anders Thorell, Professor
- Email: anders.thorell@erstadiakoni.se
- Phone: +46 8 714 6541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.