Clinical Trials Directory

Trials / Completed

CompletedNCT05074082

Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy

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

Status
Completed
Phase
Study type
Observational
Enrollment
883 (actual)
Sponsor
St Vincent's University Hospital, Ireland · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

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.

Conditions

Interventions

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

Timeline

Start date
2021-07-31
Primary completion
2022-07-01
Completion
2023-03-01
First posted
2021-10-12
Last updated
2023-03-31

Locations

1 site across 1 country: Ireland

Source: ClinicalTrials.gov record NCT05074082. Inclusion in this directory is not an endorsement.