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

Sponsor
St Vincent's University Hospital, Ireland (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05074069
Collaborator
(none)
1,000
1
6
165.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
PelvEx 7: A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Morbidity [July 2016 - July 2021]

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

  2. Gynaecological Reconstruction [July 2016 - July 2021]

    Number of patients with each method of reconstruction

  3. Perineal wound complications [July 2016 - July 2021]

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

Secondary Outcome Measures

  1. Dyspareunia [July 2016 - July 2021]

    Dyspareunia

  2. Return to intercourse [July 2016 - July 2021]

    Return to intercourse

  3. Pelvic pain [July 2016 - July 2021]

    Chronic pelvic pain by type of reconstruction

  4. Histological outcomes [July 2016 - July 2021]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Vincent's Hospital Dublin Ireland D4

Sponsors and Collaborators

  • St Vincent's University Hospital, Ireland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Des Winter, Professor Desmond C Winter, St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT05074069
Other Study ID Numbers:
  • PelvEx 7
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021