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Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509376
Acronym
RmB
Enrollment
100
Registered
2018-04-26
Start date
2018-04-01
Completion date
2021-12-31
Last updated
2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastasis Recti

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.

Detailed description

Abdominal diastasis recti (ADR) persists after pregnancies in one third of women. Traditionally plain ADR has been managed conservatively. There is some evidence that ADR reduces abdominal integrity and functional strength, contributing to pelvic instability and back pain. However, patients are referred to a surgeon mainly because of some other primary concern and ADR is an additional condition: in the case of excess skin-subcutis, the person is referred to a plastic and reconstructive surgeon for abdominoplasty and in the case of midline hernia, to a general surgeon. In combination with abdominoplasty the plication of the superficial aponeurosis of recti muscles is the most commonly used reconstructive technique. There is a wide variety of different plication procedures available. Convincing data of the long-term results of ADR repair are lacking especially when ADR is severe. Some studies have reported large recurrence rates. Polypropylene mesh repair is an evidence-based technique to ensure a strong and reliable abdominal wall repair in ventral hernias or in high risk laparotomy wounds. Large retromuscular or intraperitoneal meshes have been used also in ARD repair. This study reports a novel surgical technique aimed at reliable and mini-invasive open repair of ADR with or without midline hernia combined by abdominoplasty for symptomatic ADR patients. In RmB (roll mesh in between) method the investigators bury a narrow piece of self-gripping mesh inside the plicated linea alba to give tensile strength to plication. Patients are randomized to a suture plication group or RmB group. Outcome evaluation is performed by clinical examination with video recorded movement control tests and with structured questionnaires for Quality of Life (RAND36) and for low back pain (LBP) (Oswestry 2.0). Evaluation is done three times: when recruiting the patient, after a conservative 3-6 months therapy with written instructions and one year after the intervention. Complications and recurrences are recorded as well. Outcomes The effect of ADR repair on LBP and movement control problems Patient satisfaction and complications of ADR repair after the two techniques

Interventions

PROCEDURESuture repair

The diastasis is repaired with continous nylon suture

PROCEDURERolled mesh repair

Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis

Sponsors

Oulu University Hospital
CollaboratorOTHER
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The physiotherapist doing the clinical examinations at different phases of the study

Intervention model description

Patients are randomised to a suture repair or suture with mesh repair

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Symptomatic diastasis recti (\> 3 cm) after pregnancies, with or without a midline hernia

Exclusion criteria

* BMI \> 28, * smoking * less than a year since the previous pregnancy or still breast feeding * planning further pregnancies

Design outcomes

Primary

MeasureTime frameDescription
Low back painAt one yearImprovement in Oswestry 2.0 score

Secondary

MeasureTime frameDescription
Recurrenceat 1 yearNumber of symptomatic, recurrent diastasis \> 3 cm
Quality of lifeat one yearRAND 36 questionnaire

Countries

Finland

Contacts

Primary ContactJaana Vironen
jaana.vironen@hus.fi+358504422892
Backup ContactReetta Tuominen
reetta.tuominen@hus.fi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026