NCT05759663: MIRRADRCT

MIRRAD Versus Plication of Entire Diastasis Trial

Not yet recruiting NA Last updated 3 January 2025

What this trial tests

NA trial testing MIRRAD in Muscle Diastasis in 120 participants. Not yet recruiting.

Timeline

1 August 2025

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 August 2025
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	2 locations across Sweden

Drugs / interventions tested

• MIRRAD
• Plication of the entire diastasis arm

Conditions studied

• Muscle Diastasis — all drugs for Muscle Diastasis →

Sponsor

Karolinska Institutet

Who can join

Adults 20 to 50, female only, with Muscle Diastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.