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临床试验/NCT05074082
NCT05074082已完成不适用

PelvEx 8: Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy

St Vincent's University Hospital, Ireland1 个研究点 分布在 1 个国家目标入组 883 人开始时间: 2021年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
883
试验地点
1
主要终点
Clavien-Dindo grade III or greater

研究概览

简要总结

Flap reconstruction is utilised increasingly for repair of skin and soft tissue defects following pelvic exenteration. Many methods have been proposed but the outcomes associated with each remain largely unknown and the choice dependant on surgeon preference and patient/ disease characteristics. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.

详细描述

Locally advanced pelvic malignancies pose numerous technical difficulties to oncological surgeons, particularly where extended resections are performed. The repair of skin and soft tissue defects after radical resections are among the most challenging. Complications related to wound healing are among the most commonly encountered. They can increase rates of infection in the short-term and often become chronic and difficult to treat. This is particularly relevant in the context of pelvic exenteration, where a larger dead space confers a greater risk of deep perineal wound infection and prior (chemo)radiotherapy impairs tissue quality with suboptimal healing. Primary closure may also lead to higher tension closure where there is a bigger defect, further compounding risk. The first meta-analysis comparing primary closure to flap closure noted a two-fold increased risk of overall wound complications with primary closure (1).

With increasingly extensive procedures being carried out in dedicated centres over recent decades, the use of flap reconstruction for closure of pelvic oncological defects has increased significantly. Perineal reconstruction has been shown to decrease the incidence the wound of break-down as well as the need for a secondary repair of dehiscence (2). More importantly, these complications have been shown to be decreasing over time, suggesting improved techniques and/or better perioperative care. However, this is countered by an increase in the incidence of overall minor complications and the possibility of flap failure necessitating a return to theatre. Flap formation is a morbid procedure in its own right and can involve more intensive nursing care and restrict a patient's mobility after pelvic exenteration, further predisposing to post-operative complications and increasing length-of-stay.

The Vertical Rectus Abdominis Muscle (VRAM) flap remains one of the most commonly used and is considered by some to be the gold standard. However, a wide variety of methods have been proposed but exactly how often each is employed and with what outcomes remains largely unknown and is of great interest to surgeons involved in pelvic reconstruction. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynaecological, Sarcoma)
  • Aged over 18 years
  • Undergoing a multi-visceral extended pelvic resection and requiring reconstruction of a skin and soft tissue defect as a result
  • Time period: 1st July 2016 - 1st July 2021

排除标准

  • Strong evidence of metastatic or peritoneal disease
  • No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration, or flap reconstruction performed as a delayed procedure or as a response to a complication of prior pelvic exenteration
  • Insufficient patient follow-up (Minimum of 30 days)

结局指标

主要结局

Clavien-Dindo grade III or greater

时间窗: July 2016 - July 2021

Need for re-intervention by flap type

Flap reconstruction by procedure

时间窗: July 2016 - July 2021

Type of flap formation

Major flap dehiscence

时间窗: July 2016 - July 2021

By flap type

Morbidity

时间窗: July 2016 - July 2021

Short-term (\<30 days) outcomes associated with each type

次要结局

  • Length of stay(July 2016 - July 2021)

研究者

发起方
St Vincent's University Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Des Winter

Professor Desmond C Winter

St Vincent's University Hospital, Ireland

研究点 (1)

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