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

PelvEx 7: 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.

Study Overview

• Status: Completed
• Conditions: Pelvic Cancer
• Intervention / Treatment: Procedure: Gynaecological reconstruction

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 Type: Observational
• Enrollment (Actual): 334

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D4
    • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age who have undergone pelvic exenteration/multi-visceral resection with gynaecological organ reconstruction for a locally advanced pelvic malignancy in a participating PelvEx centre between July 2016 and July 2021.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neovaginal reconstruction; Neovaginal reconstruction post-vulvovaginal resection	Procedure: Gynaecological reconstruction; Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation
Flap Reconstruction; Flap closure of perineal defect post-gynaecological organ resection	Procedure: Gynaecological reconstruction; Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation
No reconstruction/Primary closure; Primary closure of defect post-multivisceral, gynaecological organ-involving, resection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St Vincent's University Hospital, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pelvic Neoplasms
• Other Study ID Numbers: PelvEx 7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients will be identified by a key from the nominated study coordinator from each site, with no individual or identifiable data to be shared between researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No