Clinical trial NCT05074082: Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy
Official title: PelvEx 8: Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Cancer
Rectal Cancer
Flap Disorder
Flap Ischemia
Flap Necrosis
Perioperative Complication
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
Collaborators: name: PelvEx
First posted: 2021-10-12
Enrollment: 883
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Flap reconstruction by procedure
timeFrame: July 2016 - July 2021
measure: Morbidity
timeFrame: July 2016 - July 2021
measure: Clavien-Dindo grade III or greater
timeFrame: July 2016 - July 2021
measure: Major flap dehiscence
timeFrame: July 2016 - July 2021
Secondary outcomes:
measure: Length of stay
timeFrame: July 2016 - July 2021
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Vincent's Hospital
Study officials:
affiliation: St. Vincent's Healthcare Group
name: Desmond C Winter, MD
role: PRINCIPAL_INVESTIGATOR
References: