Clinical trial · Observational
PelvEx - Beating the Empty Pelvis Syndrome
Pathophysiology, Mitigation, and a Core Outcome Set for the Empty Pelvis Syndrome After Pelvic Exenteration: a Delphi-study by the PelvEx Collaborative
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Empty Pelvis Syndrome | — | UNRESOLVED | — |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
| Pelvic Exenteration | — | UNRESOLVED | — |
| Pelvic Neoplasm | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consensus study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Healthcare Professionals
- description
- Members of The PelvEx Collaborative who are experts in performing pelvic exenteration surgery, and managing the complications relating to the empty pelvis syndrome as a result of this surgery.
- interventionNames
- Other: Consensus study
- label
- Patient Representatives
- description
- Patients that have undergone pelvic exenteration surgery and likely to have been exposed to the morbidity of the empty pelvis syndrome.
- interventionNames
- Other: Consensus study
Primary outcomes (1)
- measure
- A core outcome set for the empty pelvis syndrome
- timeFrame
- 8 months
- description
- Consensus process involving both healthcare professionals and patient representatives to define measurable outcomes for the empty pelvis syndrome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthcare professional and member of The PelvEx Collaborative 2. Patient 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) 3. Non-English speaking healthcare professionals and patient representatives where language translation is possible. Exclusion Criteria: 1. Patient representatives that have not undergone pelvic exenteration surgery. 2. Non-English speaking healthcare professionals and patient representatives where language translation is not possible. 3. Individuals unable to take part in the online consensus process, or unable to give online consent digitally.
References
Publications (4)
- BACKGROUNDJohnson YL, West MA, Gould LE, Drami I, Behrenbruch C, Burns EM, Mirnezami AH, Jenkins JT. Empty pelvis syndrome: a systematic review of reconstruction techniques and their associated complications. Colorectal Dis. 2022 Jan;24(1):16-26. doi: 10.1111/codi.15956. Epub 2021 Oct 25. PMID 34653292
- BACKGROUNDSutton PA, Brown KGM, Ebrahimi N, Solomon MJ, Austin KKS, Lee PJ. Long-term surgical complications following pelvic exenteration: Operative management of the empty pelvis syndrome. Colorectal Dis. 2022 Dec;24(12):1491-1497. doi: 10.1111/codi.16238. Epub 2022 Jul 19. PMID 35766998
- BACKGROUNDBlazeby JM, Macefield R, Blencowe NS, Jacobs M, McNair AG, Sprangers M, Brookes ST; Research Group of the Core Outcomes and iNformation SEts iN SUrgical Studies-Oesophageal Cancer; Consensus Group of the Core Outcomes and iNformation SEts iN SUrgical Studies-Oesophageal Cancer. Core information set for oesophageal cancer surgery. Br J Surg. 2015 Jul;102(8):936-43. doi: 10.1002/bjs.9840. Epub 2015 May 18. PMID 25980524
- DERIVEDPelvEx Collaborative. Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol. BMJ Open. 2024 Feb 5;14(2):e076538. doi: 10.1136/bmjopen-2023-076538. PMID 38316595