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

Diastasis Recti Clinical Trial

— RmB  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03509376
• Other study ID #: HUS/26/2018
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2018
• Last updated: April 25, 2018
• Start date: April 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2018
• Source: Helsinki University Central Hospital
• Contact: Jaana Vironen
• Phone: +358504422892
• Email: jaana.vironen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Diastasis Recti
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Finland	HUCH Jorvi Hospital, department of Surgery	Espoo
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain	Improvement in Oswestry 2.0 score	At one year
Secondary	Recurrence	Number of symptomatic, recurrent diastasis > 3 cm	at 1 year
Secondary	Quality of life	RAND 36 questionnaire	at one year