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临床试验/NCT03509376
NCT03509376Unknown不适用

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

Helsinki University Central Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Low back pain

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The physiotherapist doing the clinical examinations at different phases of the study

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Symptomatic diastasis recti (> 3 cm) after pregnancies, with or without a midline hernia

排除标准

  • •BMI > 28,
  • •less than a year since the previous pregnancy or still breast feeding
  • •planning further pregnancies

研究组 & 干预措施

Suture repair

Experimental

Diastasis recti is repaired using nylon suture for the plication

干预措施: Suture repair (Procedure)

Rolled mesh repair

Experimental

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

干预措施: Rolled mesh repair (Procedure)

结局指标

主要结局

Low back pain

时间窗: At one year

Improvement in Oswestry 2.0 score

次要结局

  • Recurrence(at 1 year)
  • Quality of life(at one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaana Vironen

Chief surgeon

Helsinki University Central Hospital

研究点 (2)

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