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

NCT05074069 | Completed

• 1 other identifier: PelvEx 7
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Dyspareunia

  July 2016 - July 2021

• Return to intercourse

  July 2016 - July 2021

• Pelvic pain

  July 2016 - July 2021

• Histological outcomes

  July 2016 - July 2021

Study Arms (3)

Neovaginal reconstruction

Neovaginal reconstruction post-vulvovaginal resection

Procedure: Gynaecological reconstruction

Flap Reconstruction

Flap closure of perineal defect post-gynaecological organ resection

Procedure: Gynaecological reconstruction

No reconstruction/Primary closure

Primary closure of defect post-multivisceral, gynaecological organ-involving, resection

Interventions

Gynaecological reconstruction PROCEDURE

Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation

Flap Reconstruction; Neovaginal reconstruction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gynaecological organ reconstruction only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

Study Sites (1)

St. Vincent's Hospital

Dublin, D4, Ireland

Location

Related Publications (1)

• PelvEx Collaborative. A review of functional and surgical outcomes of gynaecological reconstruction in the context of pelvic exenteration. Surg Oncol. 2024 Feb;52:101996. doi: 10.1016/j.suronc.2023.101996. Epub 2023 Nov 22.

  PMID: 38096764 DERIVED

MeSH Terms

Conditions

Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Desmond C Winter

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)