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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture repair | Experimental | Diastasis recti is repaired using nylon suture for the plication |
|
| Rolled mesh repair | Experimental | Diastasis recti is repaired with self gripping mesh to reinforce the suture line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture repair | Procedure | The diastasis is repaired with continous nylon suture |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Low back pain | Improvement in Oswestry 2.0 score | At one year |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Number of symptomatic, recurrent diastasis > 3 cm | at 1 year |
| Quality of life | RAND 36 questionnaire | at one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaana Vironen | Contact | +358504422892 | jaana.vironen@hus.fi | |
| Reetta Tuominen | Contact | reetta.tuominen@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Tiina Jahkola | Helsinki University Central Hospital | Principal Investigator |
| Tero Rautio | Oulu University Hospital | Principal Investigator |
| Katariina Kilpivaara |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUCH Jorvi Hospital, department of Surgery | Recruiting | Espoo | 02480 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41289051 | Derived | 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. |
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Patients are randomised to a suture repair or suture with mesh repair
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The physiotherapist doing the clinical examinations at different phases of the study
| Rolled mesh repair |
| Procedure |
Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis |
|
| Oulu University Hospital |
| Principal Investigator |
| Oulu University Hospital | Recruiting | Oulu | Finland |
|