Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control
RmB
Operative Correction of Abdominal Rectus Diastasis (ARD): the Effect on Low Back Pain and Movement Control. A Randomized, Prospective Trial Comparing Novel, Mini-invasive Mesh Repair to Plication
1 other identifier
interventional
100
1 country
2
Brief Summary
This study is a randomized controlled trial comparing two ADR repair methods: nylon suturing and nylon suture with mesh enforcement. The ADR correction is performed simultaneously with abdominoplasty/ modified skin reduction abdominoplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 26, 2018
April 1, 2018
1.8 years
April 11, 2018
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Low back pain
Improvement in Oswestry 2.0 score
At one year
Secondary Outcomes (2)
Recurrence
at 1 year
Quality of life
at one year
Study Arms (2)
Suture repair
EXPERIMENTALDiastasis recti is repaired using nylon suture for the plication
Rolled mesh repair
EXPERIMENTALDiastasis recti is repaired with self gripping mesh to reinforce the suture line
Interventions
Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis
Eligibility Criteria
You may qualify if:
- Symptomatic diastasis recti (\> 3 cm) after pregnancies, with or without a midline hernia
You may not qualify if:
- BMI \> 28,
- smoking
- less than a year since the previous pregnancy or still breast feeding
- planning further pregnancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Oulu University Hospitalcollaborator
Study Sites (2)
HUCH Jorvi Hospital, department of Surgery
Espoo, 02480, Finland
Oulu University Hospital
Oulu, Finland
Related Publications (1)
Tuominen R, Saxen J, Jahkola T, Mikkonen J, Arokoski J, Luomajoki H, Vironen J. Rectus diastasis repair with and without mesh at 1 year: randomized clinical trial. Br J Surg. 2025 Nov 6;112(11):znaf231. doi: 10.1093/bjs/znaf231.
PMID: 41289051DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Tiina Jahkola
Helsinki University Central Hospital
- PRINCIPAL INVESTIGATOR
Tero Rautio
Oulu University Hospital
- PRINCIPAL INVESTIGATOR
Katariina Kilpivaara
Oulu University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The physiotherapist doing the clinical examinations at different phases of the study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief surgeon
Study Record Dates
First Submitted
April 11, 2018
First Posted
April 26, 2018
Study Start
April 1, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2021
Last Updated
April 26, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share