NCT06078085

Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

Abdominal Rectus Diastasis Microscopy and Rehabilitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomised controlled trial is to evaluate the effect of a postoperative rehabilitation program after surgical correction of abdominal rectus diastasis. The main questions to answer are: 1. Does structured postoperative abdominal exercise improve abdominal wall function in three months and twelve months after surgical correction of abdominal rectus diastasis 2. Does connective tissue components differ in patients with abdominal rectus diastasis when compared to healthy individuals?

Detailed description

The investigators want to include patients in Sweden that are eligible for surgical correction of their abdominal rectus diastasis. Patients will be recruited at the surgical clinic at four hospitals in Sweden. After being informed about the study and potential risks, all patient give written informed consent. Randomisation is performed upon inclusion. All patients undergo surgery by plication of the linea alba. A blood sample is collected prior to the surgery. During the surgery the skin, connective tissue and rectus muscle are biopsied. On the first postoperative day, another blood sample is collected. Follow up is conducted three and twelve months after surgery.

Conditions

• Abdominal Rectus Diastasis

Interventions

Type	Name	Description
OTHER	Postoperative rehabilitation program	The rehabilitation program is created by a physical therapist

Timeline

• Start date: 2023-03-29
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2023-10-11
• Last updated: 2025-01-15

Locations

4 sites across 1 country: Sweden