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

Completed

• Conditions: Pelvic Cancer
• Interventions: Procedure: Gynaecological reconstruction

• Registration Number: NCT05074069
• Lead Sponsor: St Vincent's University Hospital, Ireland

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-12
• Primary Completion: 2022-07-01
• Study Completion: 2022-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 334

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Flap Reconstruction	Gynaecological reconstruction	Flap closure of perineal defect post-gynaecological organ resection
Neovaginal reconstruction	Gynaecological reconstruction	Neovaginal reconstruction post-vulvovaginal resection

Primary Outcome Measures

Name	Time	Method
Morbidity	July 2016 - July 2021	Number of patients experiencing short-term (up to 30 days postoperatively) morbidity
Perineal wound complications	July 2016 - July 2021	Number of patients with superficial wound infections, abscess, dehiscence by type of reconstruction
Gynaecological Reconstruction	July 2016 - July 2021	Number of patients with each method of reconstruction

Secondary Outcome Measures

Name	Time	Method
Dyspareunia	July 2016 - July 2021	Dyspareunia
Histological outcomes	July 2016 - July 2021	Radicality of resection, e.g. R0, R1 or R2, and histological subtypes
Return to intercourse	July 2016 - July 2021	Return to intercourse
Pelvic pain	July 2016 - July 2021	Chronic pelvic pain by type of reconstruction

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇮🇪 Dublin, Ireland