Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control
NCT ID: NCT03509376
Last Updated: 2018-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-04-01
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Isometric Preoperative Exercise on Autologous Arteriovenous Fistulas. Randomized Clinical Trial
NCT03213756
Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure
NCT04831008
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access
NCT06835829
Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)
NCT06078085
Anesthetic Technique for AV Fistulae Creation
NCT01727557
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Suture repair
Diastasis recti is repaired using nylon suture for the plication
Suture repair
The diastasis is repaired with continous nylon suture
Rolled mesh repair
Diastasis recti is repaired with self gripping mesh to reinforce the suture line
Rolled mesh repair
Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* smoking
* less than a year since the previous pregnancy or still breast feeding
* planning further pregnancies
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oulu University Hospital
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jaana Vironen
Chief surgeon
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tiina Jahkola
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Tero Rautio
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Katariina Kilpivaara
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HUCH Jorvi Hospital, department of Surgery
Espoo, , Finland
Oulu University Hospital
Oulu, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUS/26/2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.