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NCT Number: NCT06078085

Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

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?

Recruiting

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Key information

Conditions

Abdominal Rectus Diastasis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgical clinic at Mora Hospital, Mora, Dalarna County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative rehabilitation program

Other

The rehabilitation program is created by a physical therapist

Primary outcomes

  1. 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

  2. Number of repetitions of deadlift with 20 kilograms

    Time frame: Three and twelve months after surgery

    Abdominal wall function measured

Secondary outcomes

  1. VHPQ

    Time frame: Three and twelve months after surgery

    Ventral hernia pain questionnaire collect information on the patients experience of pain

  2. PDI-score

    Time frame: 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.

  3. PGPQ

    Time frame: Three and twelve months after surgery

    Patient goal priority questionnaire collect information on activities the patient wish to improve using the intervention

  4. PFDI-20 short form

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Annie Silfvenius, Phd-student

CONTACT

[email protected]

+46703078690

Karin Strigård, Professor

CONTACT

[email protected]

+46907853583

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Abdominal Rectus Diastasis Microscopy and Rehabilitation

Acronym: AMIRE

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Oct 11, 2023
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.