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Enrolling By Invitation
NCT05683795
PelvEx - Beating the Empty Pelvis Syndrome
Conditions: Empty Pelvis Syndrome, Pelvic Exenteration, Pelvic Neoplasm, Pelvic Cancer, Rectal Cancer, Postoperative Complications
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 150
Sponsor: University of Southampton
Location: United Kingdom
Summary
The empty pelvis syndrome is an unsolved and poorly defined problem severely affecting patients that have pelvic exenteration surgery, and also the teams looking after them.
It is unclear what the anatomical and pathophysiological causes of the empty pelvis syndrome are, how it can be prevented, and how its sequelae can be measured.
The evidence to guide decisions around the empty pelvis syndrome is of low quality, and so there is a large amount of variation in approaches between different hospitals.This consensus study will define a core outcome set for the empty pelvis syndrome, and establish current levels of consensus on pathophysiology and mitigation of the empty pelvis syndrome through a modified-Delphi process involving both healthcare professionals and patient representatives.
Eligibility Criteria
Inclusion Criteria:Healthcare professional and member of The PelvEx CollaborativePatient representative that has undergone pelvic exenteration surgery - defined as surgery to remove multiple organs from the pelvis, including beyond total mesorectal excision plane operations, for any pelvic malignancy (i.e., primary or recurrent colorectal, gynaecological, urological, and connective tissue disease)Non-English speaking healthcare professionals and patient representatives where language translation is possible.Exclusion Criteria:Patient representatives that have not undergone pelvic exenteration surgery.Non-English speaking healthcare professionals and patient representatives where language translation is not possible.Individuals unable to take part in the online consensus process, or unable to give online consent digitally.
Source: ClinicalTrials.gov (NCT05683795). StuddyBuddy aggregates publicly available trial information.