Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy

NCT05074082 | Completed

• 1 other identifier: PelvEx 8
• Study Type: observational
• Target: 883
• Locations: 1 country
• Sites: 1

Brief Summary

Flap reconstruction is utilised increasingly for repair of skin and soft tissue defects following pelvic exenteration. Many methods have been proposed but the outcomes associated with each remain largely unknown and the choice dependant on surgeon preference and patient/ disease characteristics. This review sought to assess the preferred methods for perineal reconstruction following pelvic exenteration by retrospectively assessing the outcomes associated with each at an international, multi-centre level.

Conditions

Pelvic Cancer; Rectal Cancer; Flap Disorder; Flap Ischemia; Flap Necrosis; Perioperative Complication

Outcome Measures

Primary Outcomes (4)

• Flap reconstruction by procedure

  Type of flap formation

  July 2016 - July 2021

• Morbidity

  Short-term (\<30 days) outcomes associated with each type

  July 2016 - July 2021

• Clavien-Dindo grade III or greater

  Need for re-intervention by flap type

  July 2016 - July 2021

• Major flap dehiscence

  By flap type

  July 2016 - July 2021

Secondary Outcomes (1)

• Length of stay

  July 2016 - July 2021

Study Arms (1)

Flap reconstruction

Patients who had a flap formation as part of a multi-visceral extended resection for advanced pelvic (rectal, urological, gynaecological, sarcomatous origin) malignancy

Procedure: Flap reconstruction

Interventions

Flap reconstruction PROCEDURE

Formation of a (myo-/fascio-)cutaneous flap for repair of a skin and soft tissue defect

Also known as: VRAM flap, ORAM flap, Gracilis flap, IGAP flap, Omental flap

Flap reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing flap reconstruction of a skin or soft tissue defect as part of a multi-visceral extended resection for pelvic malignancy.

You may qualify if:

• Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynaecological, Sarcoma)
• Aged over 18 years
• Undergoing a multi-visceral extended pelvic resection and requiring reconstruction of a skin and soft tissue defect as a result
• Time period: 1st July 2016 - 1st July 2021

You may not qualify if:

• Strong evidence of metastatic or peritoneal disease
• No immediate flap reconstruction performed at time of extended pelvic resection/pelvic exenteration, or flap reconstruction performed as a delayed procedure or as a response to a complication of prior pelvic exenteration
• Insufficient patient follow-up (Minimum of 30 days)

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead
• PelvEx: collaborator

Study Sites (1)

St. Vincent's Hospital

Dublin, D4, Ireland

Location

MeSH Terms

Conditions

Pelvic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Desmond C Winter, MD

  St. Vincent's Healthcare Group

  PRINCIPAL INVESTIGATOR

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 31, 2021
• Primary Completion: July 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)