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Completed

NCT Number: NCT05074069

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St. Vincent's Hospital

Dublin, D4, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Gynaecological reconstruction

Procedure

Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation

Primary outcomes

  1. Morbidity

    Time frame: July 2016 - July 2021

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

  2. Gynaecological Reconstruction

    Time frame: July 2016 - July 2021

    Number of patients with each method of reconstruction

  3. Perineal wound complications

    Time frame: July 2016 - July 2021

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

Secondary outcomes

  1. Dyspareunia

    Time frame: July 2016 - July 2021

    Dyspareunia

  2. Return to intercourse

    Time frame: July 2016 - July 2021

    Return to intercourse

  3. Pelvic pain

    Time frame: July 2016 - July 2021

    Chronic pelvic pain by type of reconstruction

  4. Histological outcomes

    Time frame: July 2016 - July 2021

    Radicality of resection, e.g. R0, R1 or R2, and histological subtypes

Sponsors and collaborators

Lead sponsor

St Vincent's University Hospital, Ireland

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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