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

Pelvic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05074069
• Other study ID #: PelvEx 7
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2023
• Source: St Vincent's University Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Cancer
• Pelvic Neoplasms

Intervention

Procedure:
• Gynaecological reconstruction
Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation

Locations

Country	Name	City	State
Ireland	St. Vincent's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's University Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Number of patients experiencing short-term (up to 30 days postoperatively) morbidity	July 2016 - July 2021
Primary	Gynaecological Reconstruction	Number of patients with each method of reconstruction	July 2016 - July 2021
Primary	Perineal wound complications	Number of patients with superficial wound infections, abscess, dehiscence by type of reconstruction	July 2016 - July 2021
Secondary	Dyspareunia	Dyspareunia	July 2016 - July 2021
Secondary	Return to intercourse	Return to intercourse	July 2016 - July 2021
Secondary	Pelvic pain	Chronic pelvic pain by type of reconstruction	July 2016 - July 2021
Secondary	Histological outcomes	Radicality of resection, e.g. R0, R1 or R2, and histological subtypes	July 2016 - July 2021