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临床试验/NCT02950194
NCT02950194Unknown不适用

Navel Sparing Retro-muscular Mesh Augmentation and Panniculectomy for the Treatment of Post-partum Abdominal Wall Insufficiency (PPAWI)

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Evaluation of the rectus diastasis by ultrasound

研究概览

简要总结

The aim of this study is to evaluate this multidisciplinary surgical approach of PPAWI (one-step procedure a panniculectomy by a plastic surgeon was performed together with a mesh augmentation of the abdominal wall by a general surgeon) at least 1 year post-operatively. Evaluation of the PPAWI approach by clinical examination with Quality of Life questionnaire and by ultrasound examination.

详细描述

PPAWI (post partum abdominal wall insufficiency) is an acronym first introduced during Congress of the European Hernia Society in 2013. It is a pathological condition induced by abdominal distension during pregnancy. General laxity of the anterior abdominal wall develops because of diastasis of the rectus abdominis muscles and excess of skin and panniculus. This has important repercussion on abdominal wall function and its aesthetics. This diastasis is induced by abdominal distension and hormonal influences.

To evaluate diastasis of the rectus abdominis the inter-recti distance (IRD) is measured by ultrasound. When it is 3cm or more, it is defined as diastasis of recti abdominis.

An operation is indicated when there is an aesthetic problem and/or the abdominal wall function is impaired e.g. by loss of integrity of myofascial system and altered angle of attachment, which results in loss of abdominal muscle strength and endurance and loss of pelvic stabilization.

Since September 2013, 11 patients underwent an one-step procedure in which a panniculectomy/ abdominoplasty performed by a plastic surgeon was combined by a mesh augmentation of the abdominal wall with a Parietex Progrip Self Fixating Mesh performed by a general surgeon in the Maria Middelares hospital, Ghent, Belgium.

The study will be conducted in the department of surgery in the Maria Middelares hospital, Ghent, Belgium. Dr. Filip Muysoms (general surgeon) selected all patient that have previous been operated together with Dr. Rudolf Vertriest (plastic surgeon) with PPAWI technique. Ultrasound will be performed by Dr. Beckers subsequently pre- and postoperative. Pictures to evaluate the esthetic result will be taken by Dr. Vertriest pre- and postoperative.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Adult female patients who underwent an abdominal wall repair and an abdominoplasty in one-step technique

排除标准

  • Pregnancy
  • No Informed Consent

结局指标

主要结局

Evaluation of the rectus diastasis by ultrasound

时间窗: more than 12 months post-operatively

Evaluation of the rectus diastasis after abdominoplasty with mesh augmentation using ultrasound at least 12 months post-operatively

次要结局

  • Aesthetic result(more than 12 months post-operatively)
  • Quality of Life score(more than 12 months post-operatively)

研究者

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Muysoms

surgeon

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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