Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE) (AMIRE)

Abdominal Rectus Diastasis Microscopy and Rehabilitation

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?

Study Overview

• Status: Recruiting
• Conditions: Abdominal Rectus Diastasis
• Intervention / Treatment: Other: Postoperative rehabilitation program

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annie Silfvenius, Phd-student; Phone Number: +46703078690; Email: Annie.silfvenius@umu.se
• Study Contact Backup: Name: Karin Strigård, Professor; Phone Number: +46907853583; Email: karin.strigard@umu.se

Study Locations

• Sweden
  • Dalarna
    • Mora, Dalarna, Sweden, 79251
      • Recruiting
      • Surgical clinic at Mora Hospital
      • Contact: Anna Nordin, Research assistent; Phone Number: +460250-493313; Email: anna.b.nordin@regiondalarna.se
  • Norrbotten
    • Gällivare, Norrbotten, Sweden, 98234
      • Recruiting
      • Surgical clinic at Gällivare Hospital
      • Contact: Gunnar Nordqvist; Email: gunnar.nordqvist@norrbotten.se
  • Västerbotten
    • Skellefteå, Västerbotten, Sweden, 93141
      • Recruiting
      • Surgical clinic at the district hospital of Skellefteå
      • Contact: Annie Silfvenius, Phd-student; Phone Number: +46703078690; Email: Annie.silfvenius@umu.se
    • Umeå, Västerbotten, Sweden, 90737
      • Recruiting
      • University Hospital of Umeå
      • Contact: Annie Silfvenius, Phd-student; Phone Number: +46703078690; Email: Annie.silfvenius@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis.	Other: Postoperative rehabilitation program; The rehabilitation program is created by a physical therapist
No Intervention: Control; 24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VHPQ	Ventral hernia pain questionnaire collect information on the patients experience of pain	Three and twelve months after surgery
PDI-score	Pain disability index collect information on how pain influence daily life attributes. Minimum score 0, maximum score 70. A lower score means less disability.	Three and twelve months after surgery
PGPQ	Patient goal priority questionnaire collect information on activities the patient wish to improve using the intervention	Three and twelve months after surgery
PFDI-20 short form	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).	Three and twelve months after surgery

Collaborators and Investigators

• Sponsor: Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Randomised controlled trial
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: 2022-06512-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No