Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

Not Applicable

Recruiting

• Conditions: Abdominal Rectus Diastasis
• Interventions: Other: Postoperative rehabilitation program

• Registration Number: NCT06078085
• Lead Sponsor: Umeå University

Brief 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.

Study Timeline

• Study Start: 2023-03-29
• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of repetitions of deadlift with 20 kilograms	Three and twelve months after surgery	Abdominal wall function measured
5 times sit to stand test time	Three and twelve months after surgery	Abdominal wall function measured with the 5 times sit to stand test

Secondary Outcome Measures

Name	Time	Method
VHPQ	Three and twelve months after surgery	Ventral hernia pain questionnaire collect information on the patients experience of pain
PDI-score	Three and twelve months after surgery	Pain disability index collect information on how pain influence daily life attributes. Minimum score 0, maximum score 70. A lower score means less disability.
PGPQ	Three and twelve months after surgery	Patient goal priority questionnaire collect information on activities the patient wish to improve using the intervention
PFDI-20 short form	Three and twelve months after surgery	Pelvic floor disability index short form collect information on symptoms from the urogenital organs. Minimum score 0, maximum score 40. Absence of symptoms (score 0), symptoms with mild distress (1-15), symptoms with moderate distress (16-34), symptoms with severe distress (35-40).

Trial Locations

Locations (4)

Surgical clinic at Mora Hospital; 🇸🇪 Mora, Dalarna, Sweden

Surgical clinic at Gällivare Hospital; 🇸🇪 Gällivare, Norrbotten, Sweden

Surgical clinic at the district hospital of Skellefteå; 🇸🇪 Skellefteå, Västerbotten, Sweden

University Hospital of Umeå; 🇸🇪 Umeå, Västerbotten, Sweden