The empty pelvis syndrome: a core data set from the PelvEx collaborative
PelvEx Collaborative, Alex H. Mirnezami, Ioanna Drami, Tamara Glyn, Paul Sutton, Jim Tiernan, Corina Behrenbruch, Glen Guerra, Peadar S. Waters, Natasha Woodward, S Applin, S J Charles, S A Rose, Andreas Denys, E Pape, Gabriëlle H. van Ramshorst, Dorothy I. Baker, E Bignall, I Blair, Paul Davis, Thomas L. Edwards, K. Jackson, Pien Leendertse, E Love-Mott, Lisa Mackenzie, Frank Martens, Dane Meredith, Sarah Nettleton, M P Trotman, J J M van Hecke, A M J Weemaes, N Abecasis, Eva Angenete, Omer Aziz, Nicolae Bacalbaşa, Desmond P.J. Barton, Gediminas Baseckas, Andrew D. Beggs, Kilian G. M. Brown, Pamela Buchwald, D Burling, Elaine M. Burns, Antonio Caycedo‐Marulanda, George J. Chang, Peter Coyne, Roland S. Croner, I. R. Daniels, Quentin Denost, E. S. Drozdov, T Eglinton, Eloy Espín, Martyn Evans, Kjersti Flatmark, Joakim Folkesson, Frank Frizelle, Mario Álvarez Gallego, A Gil-Moreno, Paolo Goffredo, B Griffiths, F Gwenaël, Dan Harris, L H Iversen, G V Kandaswamy, Mufaddal Kazi, Michael E. Kelly, R Kokelaar, Miranda Kusters, Melanie Langheinrich, José Tomás Larach, M L Lydrup, A Lyons, C Mann, Frank McDermott, J. R. T. Monson, Hannes Neeff, Ionuţ Negoi, J L Ng, Marios Nicolaou, Gabriella Jansson Palmer, C. N. Parnaby, Gianluca Pellino, A C Peterson, Aaron Quyn, A. Rogers, Joost Rothbarth, Feras Abu Saadeh, Avanish Saklani, Tarik Sammour, Raza Sayyed, Neil Smart, T.R. Smith, Luca Sorrentino, Scott R. Steele, Karyn B. Stitzenberg, Claire Taylor, Jüri Teras, M R Thanapal, E Thorgersen, W Vásquez-Jiménez, Jenny Waller
Abstract
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.