Perineal Flap Reconstruction Following Surgery for Advanced Pelvic Malignancy

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05074082
• Other study ID #: PelvEx 8
• Status: Completed
• Start date: July 31, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: St Vincent's University Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 883
• Est. completion date: March 1, 2023
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Flap Disorder
• Flap Ischemia
• Flap Necrosis
• Ischemia
• Necrosis
• Pelvic Cancer
• Pelvic Neoplasms
• Perioperative Complication
• Rectal Cancer

Intervention

Procedure:
• Flap reconstruction
Formation of a (myo-/fascio-)cutaneous flap for repair of a skin and soft tissue defect

Locations

Country	Name	City	State
Ireland	St. Vincent's Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
St Vincent's University Hospital, Ireland	PelvEx

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flap reconstruction by procedure	Type of flap formation	July 2016 - July 2021
Primary	Morbidity	Short-term (<30 days) outcomes associated with each type	July 2016 - July 2021
Primary	Clavien-Dindo grade III or greater	Need for re-intervention by flap type	July 2016 - July 2021
Primary	Major flap dehiscence	By flap type	July 2016 - July 2021
Secondary	Length of stay	Duration of post-operative hospital stay by flap type	July 2016 - July 2021