Background
Empty pelvis syndrome (EPS) is a significant source of morbidity following pelvic exenteration (PE), but is undefined. EPS outcome reporting and descriptors of radicality of PE are inconsistent; therefore, the best approaches for prevention are unknown. To facilitate future research into EPS, the aim of this study is to define a measurable core outcome set, core descriptor set and written definition for EPS. Consensus on strategies to mitigate EPS was also explored.
Method
Three-stage consensus methodology was used: longlisting with systematic review, healthcare professional event, patient engagement, and Delphi-piloting; shortlisting with two rounds of modified Delphi; and a confirmatory stage using a modified nominal group technique. This included a selection of measurement instruments, and iterative generation of a written EPS definition.
Results
One hundred and three and 119 participants took part in the modified Delphi and consensus meetings, respectively. This encompassed international patient and healthcare professional representation with multidisciplinary input. Seventy statements were longlisted, seven core outcomes (bowel obstruction, enteroperineal fistula, chronic perineal sinus, infected pelvic collection, bowel obstruction, morbidity from reconstruction, re-intervention, and quality of life), and four core descriptors (magnitude of surgery, radiotherapy-induced damage, methods of reconstruction, and changes in volume of pelvic dead space) reached consensus—where applicable, measurement of these outcomes and descriptors was defined. A written definition for EPS was agreed.
Conclusions
EPS is an area of unmet research and clinical need. This study provides an agreed definition and core data set for EPS to facilitate further research.
Principal Investigator: Mr Charles West
Supervisors: Professor Alex Mirnezami and Mr Malcolm West
Organisation: The PelvEx Collaborative
Sponsoring Institution: University of Southampton, UK
Disease Category: Cancer
Disease Name: Empty pelvis syndrome
Age Range: 18 - 85
Sex: Either
Nature of Intervention: Surgery
- Charities
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Delphi process
- Focus group(s)
- Systematic review
Consensus study using a modified-Delphi followed by virtual patient representative consensus meeting, and then face to face consensus conference at PelvEx 2023.
Statements for the first Delphi round were generated from a systematic review, informal discussions at PelvEx 2023, and piloting with the study steering committee.