Clinical trial NCT03509376: Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diastasis Recti
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2018-04-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomised to a suture repair or suture with mesh repair
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Low back pain
timeFrame: At one year
Secondary outcomes:
measure: Recurrence
timeFrame: at 1 year
measure: Quality of life
timeFrame: at one year
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: HUCH Jorvi Hospital, department of Surgery
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Tiina Jahkola
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Tero Rautio
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Katariina Kilpivaara
role: PRINCIPAL_INVESTIGATOR
References: