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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

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

  • Procedure: Suture repair
    • The diastasis is repaired with continous nylon suture
  • Procedure: Rolled mesh repair
    • Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis

Arms, Groups and Cohorts

  • Experimental: Suture repair
    • Diastasis recti is repaired using nylon suture for the plication
  • Experimental: Rolled mesh repair
    • Diastasis recti is repaired with self gripping mesh to reinforce the suture line

Clinical Trial Outcome Measures

Primary Measures

  • Low back pain
    • Time Frame: At one year
    • Improvement in Oswestry 2.0 score

Secondary Measures

  • Recurrence
    • Time Frame: at 1 year
    • Number of symptomatic, recurrent diastasis > 3 cm
  • Quality of life
    • Time Frame: at one year
    • RAND 36 questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Collaborator
    • Oulu University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jaana Vironen, Chief surgeon – Helsinki University Central Hospital
  • Overall Official(s)
    • Tiina Jahkola, Principal Investigator, Helsinki University Central Hospital
    • Tero Rautio, Principal Investigator, Oulu University Hospital
    • Katariina Kilpivaara, Principal Investigator, Oulu University Hospital
  • Overall Contact(s)
    • Jaana Vironen, +358504422892, jaana.vironen@hus.fi

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