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

Primary Purpose

Diastasis Recti

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Suture repair
Rolled mesh repair
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diastasis Recti

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • HUCH Jorvi Hospital, department of SurgeryRecruiting
  • Oulu University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Suture repair

Rolled mesh repair

Arm Description

Diastasis recti is repaired using nylon suture for the plication

Diastasis recti is repaired with self gripping mesh to reinforce the suture line

Outcomes

Primary Outcome Measures

Low back pain
Improvement in Oswestry 2.0 score

Secondary Outcome Measures

Recurrence
Number of symptomatic, recurrent diastasis > 3 cm
Quality of life
RAND 36 questionnaire

Full Information

First Posted
April 11, 2018
Last Updated
April 25, 2018
Sponsor
Helsinki University Central Hospital
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03509376
Brief Title
Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastasis Recti

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomised to a suture repair or suture with mesh repair
Masking
Outcomes Assessor
Masking Description
The physiotherapist doing the clinical examinations at different phases of the study
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suture repair
Arm Type
Experimental
Arm Description
Diastasis recti is repaired using nylon suture for the plication
Arm Title
Rolled mesh repair
Arm Type
Experimental
Arm Description
Diastasis recti is repaired with self gripping mesh to reinforce the suture line
Intervention Type
Procedure
Intervention Name(s)
Suture repair
Intervention Description
The diastasis is repaired with continous nylon suture
Intervention Type
Procedure
Intervention Name(s)
Rolled mesh repair
Intervention Description
Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis
Primary Outcome Measure Information:
Title
Low back pain
Description
Improvement in Oswestry 2.0 score
Time Frame
At one year
Secondary Outcome Measure Information:
Title
Recurrence
Description
Number of symptomatic, recurrent diastasis > 3 cm
Time Frame
at 1 year
Title
Quality of life
Description
RAND 36 questionnaire
Time Frame
at one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaana Vironen
Phone
+358504422892
Email
jaana.vironen@hus.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Reetta Tuominen
Email
reetta.tuominen@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiina Jahkola
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tero Rautio
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katariina Kilpivaara
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUCH Jorvi Hospital, department of Surgery
City
Espoo
ZIP/Postal Code
02480
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaana Vironen, MD PhD
Phone
+358 50 4422892
Email
jaana.vironen@hus.fi
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tero Rautio
Email
tero.rautio@ppshp.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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

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