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

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Diastasis Recti

Treatments: Procedure: Rolled mesh repair; Procedure: Suture repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03509376

HUS/26/2018

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Suture repair

Experimental group

Description:

Diastasis recti is repaired using nylon suture for the plication

Treatment:

Procedure: Suture repair

Rolled mesh repair

Experimental group

Description:

Diastasis recti is repaired with self gripping mesh to reinforce the suture line

Treatment:

Procedure: Rolled mesh repair