Clinical trial NCT05074069: A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration
Official title: PelvEx 7: A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Cancer
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 334
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Morbidity
timeFrame: July 2016 - July 2021
measure: Gynaecological Reconstruction
timeFrame: July 2016 - July 2021
measure: Perineal wound complications
timeFrame: July 2016 - July 2021
Secondary outcomes:
measure: Dyspareunia
timeFrame: July 2016 - July 2021
measure: Return to intercourse
timeFrame: July 2016 - July 2021
measure: Pelvic pain
timeFrame: July 2016 - July 2021
measure: Histological outcomes
timeFrame: July 2016 - July 2021
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Vincent's Hospital
Study officials:
References: