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Clinical Trials/NCT06078085
NCT06078085
Recruiting
Not Applicable

Abdominal Rectus Diastasis Microscopy and Rehabilitation

Umeå University4 sites in 1 country48 target enrollmentMarch 29, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Rectus Diastasis
Sponsor
Umeå University
Enrollment
48
Locations
4
Primary Endpoint
Number of repetitions of deadlift with 20 kilograms
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 29, 2023
End Date
December 31, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karin Strigård

Professor

Umeå University

Eligibility Criteria

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
  • Connective tissue disease
  • Immunosuppressive treatment
  • Umbilical hernia \> 2 cm

Outcomes

Primary Outcomes

Number of repetitions of deadlift with 20 kilograms

Time Frame: Three and twelve months after surgery

Abdominal wall function measured

5 times sit to stand test time

Time Frame: Three and twelve months after surgery

Abdominal wall function measured with the 5 times sit to stand test

Secondary Outcomes

  • VHPQ(Three and twelve months after surgery)
  • PDI-score(Three and twelve months after surgery)
  • PGPQ(Three and twelve months after surgery)
  • PFDI-20 short form(Three and twelve months after surgery)

Study Sites (4)

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