A Contemporary Review of Methods of Repair of Skin and Soft Tissue Defects Following Surgery for Advanced Pelvic Malignancy

Sponsor
St Vincent's University Hospital, Ireland (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05074082
Collaborator
PelvEx collaborative (Other)
1,000
1
7
142.9

Study Details

Study Description

Brief Summary

Flap reconstruction is performed increasingly for repair of skin and soft tissue defects following pelvic exenteration as surgeons have embarked upon increasingly radical resections. 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Flap reconstruction

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 for flap reconstruction 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
PelvEx 8: A Contemporary Review of Methods of Repair of Skin and Soft Tissue Defects Following Surgery for Advanced Pelvic Malignancy
Actual Study Start Date :
Jul 31, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Flap reconstruction

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
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
  • Outcome Measures

    Primary Outcome Measures

    1. Flap reconstruction by procedure [July 2016 - July 2021]

      Type of flap formation

    2. Morbidity [July 2016 - July 2021]

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

    3. Clavien-Dindo grade III or greater [July 2016 - July 2021]

      Need for re-intervention by flap type

    4. Major flap dehiscence [July 2016 - July 2021]

      By flap type

    Secondary Outcome Measures

    1. Length of stay [July 2016 - July 2021]

      Duration of post-operative hospital stay by flap type

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Vincent's Hospital Dublin Ireland D4

    Sponsors and Collaborators

    • St Vincent's University Hospital, Ireland
    • PelvEx collaborative

    Investigators

    • Principal Investigator: Desmond C Winter, MD, St. Vincent's Healthcare Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Des Winter, Professor Desmond C Winter, St Vincent's University Hospital, Ireland
    ClinicalTrials.gov Identifier:
    NCT05074082
    Other Study ID Numbers:
    • PelvEx 8
    First Posted:
    Oct 12, 2021
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021