MIRRAD Versus Plication of Entire Diastasis Trial

NCT05759663 | Not Yet Recruiting

• 1 other identifier: MIRRAD RCT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Background Postpartum diastasis of the rectus abdominis muscles (DRAM) has gained increasing attention as a condition that may affect abdominal trunk function but that may be alleviated by surgery. Most techniques for surgical reconstruction of DRAM are, however, associated with high costs, postoperative pain and risk of surgical complications. The aim of the present study is to evaluate a Minimal Incision Repair of Rectus Abdominis Diastasis (MIRRAD) in a randomized controlled open label trial. Altogether 120 women will be included. Population Postpartum women with DRAM of at least 2 cm. Intervention Plication of Linea alba through a 3-5 centimeter long incision at the level of the umbilicus Control Plication of the entire Linea alba through a low transverse incision. Outcome Primary outcome: Abdominal function rated with the Disability Rating Index Secondary outcomes: Operative time, postoperative stay, surgical complications, sick leave, persisting pain orated with the Ventral Pain Hernia Questionnaire, cosmetic outcome rated with BODY-Q Follow-up Follow-up one month and one year after surgery Significance If the study shows that MIRRAD is equally effective as plication of the entire Linea alba one year after surgery, it may be introduced as a standard technique for DRAM. If it is not as effective, it may still be an alternative with advantages in terms of cost benefit and the possibility to perform it as a daycare procedure.

Conditions

Muscle Diastasis

Keywords

Postpartum; Diastasis of the Rectus Abdominis Muscles; Surgery

Outcome Measures

Primary Outcomes (1)

• Abdominal trunk function

  Abdominal function assessed with Abdominal Trunk Function Protocol one year after surgery

  One year

Secondary Outcomes (10)

• Operation time

  Two hours

• Postoperative pain 4 hours after surgery

  Four hours

• Postoperative nausea 4 hours after surgery

  Four hours

• Time from surgery to discharge

  Seven days

• Surgical complications

  Thirty days

Study Arms (2)

MIRRAD

EXPERIMENTAL

A 3 cm vertical incision is made above the umbilicus. The umbilicus is de-attached from the Linea alba so that Linea alba 5-7 cm above and 3-5cm below the umbilicus is exposed. The abdominal rectus muscle diastasis is then plicated with double layer barbed suture. The first suture line is over and over continuous suture and the second suture line continuous suture line. The umbilicus is then re-attached with a single stich .

Procedure: MIRRAD

Plication of the entire diastasis arm

ACTIVE COMPARATOR

A low transverse incision is made and the subcutaneous tissue along the Linea alba dissected. If there is any hernia present in the Linea alba, it is invaginated in a plicated suture line. The entire DRAM along the Linea alba is plicated with continuous sutures. Excessive skin and subcutaneous tissue along the incision is excised and the wound closed. The subcutaneous tissue is closed with interrupted 4-0 PDS stitches.

Procedure: Plication of the entire diastasis arm

Interventions

MIRRAD PROCEDURE

Repair of the diastasis with MIRRAD technique

MIRRAD

Plication of the entire diastasis arm PROCEDURE

Plication of the entire diastasis

Plication of the entire diastasis arm

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Postpartum women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women having undergone at least one pregnancy
• Age 20 - 50 years
• Minimum 2 cm diastasis of rectus abdominis muscle at the level of the umbilicus
• BMI \< 30
• Treatment failure after six months of structured training

You may not qualify if:

• Nulliparous women
• Less than one year since last pregnancy
• Women who have not undergone structured training for at least six months
• Previous abdominal surgery through open midline incision
• Presence of excessive skin folds
• Future planned pregnancies

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karlskoga Hospital: collaborator

Study Sites (2)

Department of Surgery, Karloskoga Hospital

Karlskoga, 69144, Sweden

Location

Stockholm South General Hospital

Stockholm, 11883, Sweden

Location

MeSH Terms

Conditions

Diastasis, Muscle

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Gabriel Sandblom, Ass prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Sandblom, Ass Prof

CONTACT

+46704158218; gabriel.sandblom@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)