Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT03509376 |
Date of registration:
|
11/04/2018 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control
RmB |
Scientific 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 |
Date of first enrolment:
|
April 1, 2018 |
Target sample size:
|
100 |
Recruitment status: |
Recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT03509376 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Finland
| | | | | | | |
Contacts
|
Name:
|
Jaana Vironen |
Address:
|
|
Telephone:
|
+358504422892 |
Email:
|
jaana.vironen@hus.fi |
Affiliation:
|
|
|
Name:
|
Tiina Jahkola |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Helsinki University Central Hospital |
|
Name:
|
Tero Rautio |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Oulu University Hospital |
|
Name:
|
Katariina Kilpivaara |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Oulu University Hospital |
| | |
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
|
Health Condition(s) or Problem(s) studied
|
Diastasis Recti
|
Intervention(s)
|
Procedure: Rolled mesh repair
|
Procedure: Suture repair
|
Primary Outcome(s)
|
Low back pain
[Time Frame: At one year]
|
Secondary Outcome(s)
|
Recurrence
[Time Frame: at 1 year]
|
Quality of life
[Time Frame: at one year]
|
Secondary ID(s)
|
HUS/26/2018
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|