Textbook Outcomes After Oesophagectomy in Regional Australia

NCT06721715 | Not Yet Recruiting

• 1 other identifier: 2024/STE03324
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational cohort study is to assess textbook outcomes after oesophagectomy in a regional Australian hospital. This is a composite quality measure that include 9 parameters related to cancer care. Researchers will compares the textbook outcome rate in this regional hospital and compare it to textbook outcomes rates from other Australian hospitals, as well as hospitals overseas. Participants will not be actively involved in this study, as all data will be collected from medical records only.

Conditions

Oesophageal Cancer Nos

Keywords

oesophagectomy; oesophageal cancer; regional surgery

Outcome Measures

Primary Outcomes (1)

• Textbook outcome

  Patients who achieve a textbook outcome. This is defined when all 9 following criteria are met: R0 resection, retrieval of 15 or more lymph nodes, no intraoperative complications, no post-operative complications Clavien-Dindo grade III or higher, no readmission to the ICU, no hospital stay longer than 21 days, no mortality within 90 days, no readmission related to the procedure within 30 days of admission, and no reintervention related to the surgical procedure (operative, endoscopic or radiologic).

  from date of surgery to end of study (December 2024) for a timeframe up to 10 years

Study Arms (2)

Textbook outcome

Patients that achieve a textbook outcome after oesophagectomy

No textbook outcome

Patients who do not achieve a textbook outcome after oesophagectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent oesophagectomy at a single regional hospital in Tasmania, Australia between January 2014 and December 2023 will be included in this study,

You may qualify if:

• all patients who underwent oesophagectomy between January 2014 and December 2023

You may not qualify if:

• none

Sponsors & Collaborators

• Launceston General Hospital: lead

Study Sites (1)

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Related Publications (5)

• Kalff MC, Vesseur I, Eshuis WJ, Heineman DJ, Daams F, van der Peet DL, van Berge Henegouwen MI, Gisbertz SS. The Association of Textbook Outcome and Long-Term Survival After Esophagectomy for Esophageal Cancer. Ann Thorac Surg. 2021 Oct;112(4):1134-1141. doi: 10.1016/j.athoracsur.2020.09.035. Epub 2020 Nov 19.

  PMID: 33221197 BACKGROUND

• Kay B, Healy TE. Propofol ('Diprivan') for outpatient cystoscopy. Efficacy and recovery compared with althesin and methohexitone. Postgrad Med J. 1985;61 Suppl 3:108-14.

  PMID: 3877277 BACKGROUND

• Kalff MC, van Berge Henegouwen MI, Gisbertz SS. Textbook outcome for esophageal cancer surgery: an international consensus-based update of a quality measure. Dis Esophagus. 2021 Jul 12;34(7):doab011. doi: 10.1093/dote/doab011.

  PMID: 33744921 BACKGROUND

• Ball ED, Keefe KA, Colby E. Expression of antigens associated with small cell carcinoma of the lung on hematopoietic progenitor cells. Cancer Res. 1987 Dec 15;47(24 Pt 1):6556-9.

  PMID: 2824035 BACKGROUND

• van der Werf LR, Wijnhoven BPL, Fransen LFC, van Sandick JW, Nieuwenhuijzen GAP, Busweiler LAD, van Hillegersberg R, Wouters MWJM, Luyer MDP, van Berge Henegouwen MI. A National Cohort Study Evaluating the Association Between Short-term Outcomes and Long-term Survival After Esophageal and Gastric Cancer Surgery. Ann Surg. 2019 Nov;270(5):868-876. doi: 10.1097/SLA.0000000000003520.

  PMID: 31634182 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Renishka Sellayah, MBBS (hons) FRACS

CONTACT

+61 425 816 462; r.sellayah@gmail.com

Girish Pande, FRACS

CONTACT

+61 439 656 110; girish.pande@ths.tas.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Fellow

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)