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Completed

NCT Number: NCT05074082

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Flap reconstruction

Procedure

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

Primary outcomes

  1. Flap reconstruction by procedure

    Time frame: July 2016 - July 2021

    Type of flap formation

  2. Morbidity

    Time frame: July 2016 - July 2021

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

  3. Clavien-Dindo grade III or greater

    Time frame: July 2016 - July 2021

    Need for re-intervention by flap type

  4. Major flap dehiscence

    Time frame: July 2016 - July 2021

    By flap type

Secondary outcomes

  1. Length of stay

    Time frame: July 2016 - July 2021

    Duration of post-operative hospital stay by flap type

Sponsors and collaborators

Lead sponsor

St Vincent's University Hospital, Ireland

Other

Collaborators

  • PelvEx

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 12, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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