Diastasis RectiRmBNCT03509376
Operative Correction of Rectus Muscle Diastasis (ARD): the Effect on Low Back Pain and Movement Control
A study testing Suture repair and Rolled mesh repair in people with Diastasis Recti, run by Helsinki University Central Hospital at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- Suture repair and Rolled mesh repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Apr 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic diastasis recti (> 3 cm) after pregnancies, with or without a midline hernia
Who cannot join
- BMI > 28,
- smoking
- less than a year since the previous pregnancy or still breast feeding
- planning further pregnancies
Trial locations and contacts
2 sites in 1 country.
Reetta Tuominen contact
Finland2 sites, 2 recruiting
- Recruiting
HUCH Jorvi Hospital, department of Surgery
Espoo, 02480
Jaana Vironen, MD PhD, +358 50 4422892, jaana.vironen@hus.fi
- Recruiting
Oulu University Hospital
Oulu
Tero Rautio, tero.rautio@ppshp.fi
About this study
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
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.
Read the 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
- Conditions
- Diastasis Recti
- Being tested
- Suture repair, Rolled mesh repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture repairProcedure or surgery
The diastasis is repaired with continous nylon suture
Rolled mesh repairProcedure or surgery
Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis
| Study group | Role | What they receive |
|---|---|---|
| Suture repair | Experimental | Diastasis recti is repaired using nylon suture for the plication Receives: Procedure: Suture repair |
| Rolled mesh repair | Experimental | Diastasis recti is repaired with self gripping mesh to reinforce the suture line Receives: Procedure: Rolled mesh repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Improvement in Oswestry 2.0 score
Measured: At one year
Secondary outcomes (2)
Recurrence
Number of symptomatic, recurrent diastasis > 3 cm
Measured: at 1 year
Quality of life
RAND 36 questionnaire
Measured: at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomised to a suture repair or suture with mesh repair
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Principal investigator, Jaana Vironen, Helsinki University Central Hospital
- Investigators
- Tiina Jahkola, Principal investigator, Helsinki University Central HospitalTero Rautio, Principal investigator, Oulu University HospitalKatariina Kilpivaara, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509376
- Sponsor's protocol ID
- HUS/26/2018
- Acronym
- RmB
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tuominen R, Saxen J, Jahkola T, Mikkonen J, Arokoski J, Luomajoki H, Vironen J. Rectus diastasis repair with and without mesh at 1 year: randomized clinical trial. Br J Surg. 2025 Nov 6;112(11):znaf231. doi: 10.1093/bjs/znaf231.
PubMed 41289051
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03509376
- Acronym / sponsor ID
- RmB / HUS/26/2018
- Conditions
- Diastasis Recti
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomised to a suture repair or suture with mesh repair
| Arm | Type | Receives |
|---|---|---|
| Suture repair | Experimental | Procedure: Suture repairDiastasis recti is repaired using nylon suture for the plication |
| Rolled mesh repair | Experimental | Procedure: Rolled mesh repairDiastasis recti is repaired with self gripping mesh to reinforce the suture line |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Symptomatic diastasis recti (> 3 cm) after pregnancies, with or without a midline hernia
Key exclusion criteria (4 listed)
- BMI > 28,
- smoking
- less than a year since the previous pregnancy or still breast feeding
- planning further pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture repairThe diastasis is repaired with continous nylon suture | Procedure or surgery | Suture repair |
| Rolled mesh repairContinuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis | Procedure or surgery | Rolled mesh repair |
Primary outcome
Low back pain
Time frame: At one year
Improvement in Oswestry 2.0 score
2 secondary outcomes
Recurrence
Time frame: at 1 year
Quality of life
Time frame: at one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Derived from this study: PubMed 41289051Tuominen R, Saxen J, Jahkola T, Mikkonen J, Arokoski J, Luomajoki H, Vironen J. Rectus diastasis repair with and without mesh at 1 year: randomized clinical trial. Br J Surg. 2025 Nov 6;112(11):znaf231. doi: 10.1093/bjs/znaf231.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reetta Tuominen contact
Tiina Jahkola principal investigator
Helsinki University Central Hospital
Tero Rautio principal investigator
Oulu University Hospital
Katariina Kilpivaara principal investigator
Oulu University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture repair and Rolled mesh repair in people with Diastasis Recti, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaana Vironen (+358504422892, jaana.vironen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain (time frame: At one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.