Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Cancer, Rectal Cancer, Flap Disorder, Flap Ischemia, Flap Necrosis, Perioperative Complication

Intervention / Treatment
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* Procedure: Flap reconstruction


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Flap reconstruction<br>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<br>* Formation of a (myo-/fascio-)cutaneous flap for repair of a skin and soft tissue defect<br>* Other names: Omental flap;|

What is the study measuring?
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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 |