Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy

PelvEx 8: Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Pelvic Cancer; Flap Necrosis; Flap Disorder; Perioperative Complication; Flap Ischemia
• Intervention / Treatment: Procedure: Flap reconstruction

Detailed Description

Locally advanced pelvic malignancies pose numerous technical difficulties to oncological surgeons, particularly where extended resections are performed. The repair of skin and soft tissue defects after radical resections are among the most challenging. Complications related to wound healing are among the most commonly encountered. They can increase rates of infection in the short-term and often become chronic and difficult to treat. This is particularly relevant in the context of pelvic exenteration, where a larger dead space confers a greater risk of deep perineal wound infection and prior (chemo)radiotherapy impairs tissue quality with suboptimal healing. Primary closure may also lead to higher tension closure where there is a bigger defect, further compounding risk. The first meta-analysis comparing primary closure to flap closure noted a two-fold increased risk of overall wound complications with primary closure (1).

With increasingly extensive procedures being carried out in dedicated centres over recent decades, the use of flap reconstruction for closure of pelvic oncological defects has increased significantly. Perineal reconstruction has been shown to decrease the incidence the wound of break-down as well as the need for a secondary repair of dehiscence (2). More importantly, these complications have been shown to be decreasing over time, suggesting improved techniques and/or better perioperative care. However, this is countered by an increase in the incidence of overall minor complications and the possibility of flap failure necessitating a return to theatre. Flap formation is a morbid procedure in its own right and can involve more intensive nursing care and restrict a patient's mobility after pelvic exenteration, further predisposing to post-operative complications and increasing length-of-stay.

The Vertical Rectus Abdominis Muscle (VRAM) flap remains one of the most commonly used and is considered by some to be the gold standard. However, a wide variety of methods have been proposed but exactly how often each is employed and with what outcomes remains largely unknown and is of great interest to surgeons involved in pelvic reconstruction. 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.

• Study Type: Observational
• Enrollment (Actual): 883

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D4
    • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Formation of a (myo-/fascio-)cutaneous flap for repair of a skin and soft tissue defect; Other Names: VRAM flap; ORAM flap; Gracilis flap; IGAP flap; Omental flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Duration of post-operative hospital stay by flap type	July 2016 - July 2021

Collaborators and Investigators

• Sponsor: St Vincent's University Hospital, Ireland
• Collaborators: PelvEx
• Investigators: Principal Investigator: Desmond C Winter, MD, St. Vincent's Healthcare Group

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Ischemia; Necrosis; Pelvic Neoplasms
• Other Study ID Numbers: PelvEx 8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No