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临床试验/NCT05074069
NCT05074069已完成不适用

PelvEx 7: A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration

St Vincent's University Hospital, Ireland1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2021年7月1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
334
试验地点
1
主要终点
Morbidity

研究概览

简要总结

Patients with locally advanced pelvic malignancy undergo radical procedures, necessitate organ reconstruction. Little is known about the preferred methods of gynaecological organ reconstruction in the context of pelvic exenteration. This review aims to identify which methods are commonly used and what outcomes are associated with each technique in order to further guide future practice.

详细描述

The mainstay of treatment for patients with locally advanced pelvic malignancy is radical surgical excision combined, with (neo)adjuvant chemoradiotherapy where appropriate. The primary objective is to obtain a negative resection margin (R0) in order to achieve long-term survival. Centralisation of care and refinements in surgical technique have enabled surgeons specializing in advanced pelvic oncology to embark upon more aggressive approaches to accomplishing an R0 resection.

With improved oncological outcomes has come an increased focus on quality-of-life (QoL), functional sequelae and patient experience and survivorship. Adequate experience and proficiency with reconstructive techniques has become one of the key components for surgeons practicing in pelvic oncology. Reconstructive procedures should be undertaken with the goals of improving wound healing, reducing morbidity and restoring anatomic form and function. These factors are of utmost importance in the context of pelvic exenteration, where wound complications are prevalent as a result of a larger pelvic dead space and the potential for contamination. Adverse impact on sexual function following pelvic surgery is also common where the autonomic nerves are involved. This is further compounded by the need to resect part or all of the vulvovaginar complex as part of an extirpative procedure, with resultant declines in QoL and overall psychosexual wellbeing.

A number of methods have been proposed for reconstruction of the pelvic floor and vulva/vagina in females, including skin grafting, skin flaps, fasciocutaneous and myocutaneous flaps, as well as the formation of a neovagina in specific circumstances. Thereis a paucity of data with regard to the optimal approach to gynaecological organ reconstruction, with the majority of the literature referring to single-centre, retrospective series. This review sought to assess the preferred methods for gynaecological reconstruction at an international level, the clinical and technical particulars leading to the choice of each method and the short-term outcomes associated with each technique.

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
Female
接受健康志愿者

入选标准

  • Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynae, Sarcome)
  • Aged over 18 years
  • Undergoing a multi-visceral extended pelvic resection and requiring gynaecological reconstruction at the time of index operation
  • Time period: 1st July 2016 - 31st July 2021

排除标准

  • Strong evidence of metastatic or peritoneal disease
  • No histological evidence of gynaecological organ involvement
  • Procedure not carried out with curative intent
  • Insufficient patient follow-up (Minimum of 30 days)

结局指标

主要结局

Morbidity

时间窗: July 2016 - July 2021

Number of patients experiencing short-term (up to 30 days postoperatively) morbidity

Perineal wound complications

时间窗: July 2016 - July 2021

Number of patients with superficial wound infections, abscess, dehiscence by type of reconstruction

Gynaecological Reconstruction

时间窗: July 2016 - July 2021

Number of patients with each method of reconstruction

次要结局

  • Dyspareunia(July 2016 - July 2021)
  • Histological outcomes(July 2016 - July 2021)
  • Return to intercourse(July 2016 - July 2021)
  • Pelvic pain(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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