Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

Umeå University

Status: Enrolling

Conditions: Abdominal Rectus Diastasis

Treatments: Other: Postoperative rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT06078085

2022-06512-01

Details and patient eligibility

About

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?

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diastasis > 3 cm
• At least 1 year since child birth
• One year of steady weight after weightloss
• BMI < 30
• Males with diastasis above and below umbilicus

Exclusion criteria

• New planned pregnancy
• Smoker
• Connective tissue disease
• Immunosuppressive treatment
• Umbilical hernia > 2 cm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Intervention

Experimental group

Description:

24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis.

Treatment:

Other: Postoperative rehabilitation program

Control

No Intervention group

Description:

24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery.