PelvEx - Beating the Empty Pelvis Syndrome

NCT05683795 | Unknown

• 1 other identifier: ERGO: 77306
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Empty Pelvis Syndrome; Pelvic Exenteration; Pelvic Neoplasm; Pelvic Cancer; Rectal Cancer; Postoperative Complications

Keywords

Empty Pelvis Syndrome; Pelvic Exenteration

Outcome Measures

Primary Outcomes (1)

• A core outcome set for the empty pelvis syndrome

  Consensus process involving both healthcare professionals and patient representatives to define measurable outcomes for the empty pelvis syndrome

  8 months

Secondary Outcomes (2)

• Consensus on pathophysiology of the empty pelvis syndrome

  8 months

• Consensus on mitigation of the empty pelvis syndrome using reconstructive techniques

  8 months

Study Arms (2)

Healthcare Professionals

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.

Other: Consensus study

Patient Representatives

Patients that have undergone pelvic exenteration surgery and likely to have been exposed to the morbidity of the empty pelvis syndrome.

Other: Consensus study

Interventions

Consensus study OTHER

Modified-Delphi study and consensus meetings

Healthcare Professionals; Patient Representatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An international cohort of patients that have undergone pelvic exenteration surgery, and an international group of expert clinicians who perform pelvic exenteration surgery (The PelvEx Collaborative).

You may qualify if:

• Healthcare professional and member of The PelvEx Collaborative
• 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)
• Non-English speaking healthcare professionals and patient representatives where language translation is possible.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (5)

• Johnson 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 BACKGROUND

• Sutton 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 BACKGROUND

• Blazeby 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 BACKGROUND

• Innes K, Hudson J, Banister K, Croal B, Ramsay C, Ahmed I, Blazeby J, Gillies K; CGALL Trial Group. Core outcome set for symptomatic uncomplicated gallstone disease. Br J Surg. 2022 Apr 5:znac095. doi: 10.1093/bjs/znac095. Online ahead of print.

  PMID: 35381067 BACKGROUND

• PelvEx 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 DERIVED

MeSH Terms

Conditions

Pelvic Neoplasms; Rectal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles T West, MBBS BSc

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: January 3, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)