Diastasis Recti Clinical Trial
Official title:
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
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.
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
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