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

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.

Study Overview

• Status: Unknown
• Conditions: Diastasis Recti
• Intervention / Treatment: Procedure: Suture repair; Procedure: Rolled mesh repair

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaana Vironen; Phone Number: +358504422892; Email: jaana.vironen@hus.fi
• Study Contact Backup: Name: Reetta Tuominen; Email: reetta.tuominen@hus.fi

Study Locations

• Finland
  • Espoo, Finland, 02480
    • Recruiting
    • HUCH Jorvi Hospital, department of Surgery
    • Contact: Jaana Vironen, MD PhD; Phone Number: +358 50 4422892; Email: jaana.vironen@hus.fi
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Tero Rautio; Email: tero.rautio@ppshp.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Suture repair; Diastasis recti is repaired using nylon suture for the plication	Procedure: Suture repair; The diastasis is repaired with continous nylon suture
EXPERIMENTAL: Rolled mesh repair; Diastasis recti is repaired with self gripping mesh to reinforce the suture line	Procedure: Rolled mesh repair; Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low back pain	Improvement in Oswestry 2.0 score	At one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Oulu University Hospital
• Investigators: Principal Investigator: Tiina Jahkola, Helsinki University Central Hospital; Principal Investigator: Tero Rautio, Oulu University Hospital; Principal Investigator: Katariina Kilpivaara, Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (ACTUAL): April 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HUS/26/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No