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MIRRAD Versus Plication of Entire Diastasis Trial

NCT05759663 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-03

No results posted yet for this study

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

Interventions

PROCEDURE

MIRRAD

Repair of the diastasis with MIRRAD technique

PROCEDURE

Plication of the entire diastasis arm

Plication of the entire diastasis

Sponsors & Collaborators

Principal Investigators

  • Gabriel Sandblom, Ass prof · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759663 on ClinicalTrials.gov