The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery
1 other identifier
observational
592
1 country
1
Brief Summary
To study the diagnostic specificity and sensitivity of various modalities used for the assessment of anastomotic leak in esophagogastric surgery and to identify the most sensitive technique. Secondarily, to propose a clinical algorithm to guide clinicians in the diagnosis of anastomotic leaks esophagogastric surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2021
CompletedFirst Submitted
Initial submission to the registry
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedOctober 24, 2022
October 1, 2022
1.7 years
October 11, 2022
October 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anastomotic leak
To identify key clinical parameters that are predictive of anastomotic leak and to evaluate the effectiveness of various investigations for diagnosing anastomotic leak following upper gastrointestinal surgeries involving anastomosis
Surgery day
Study Arms (1)
Esophagogastric Surgery Patients
Patients who underwent esophageal and gastric resections requiring an anastomosis from January 2001 to March 2019
Interventions
Distal gastrectomies, total gastrectomies, bariatric gastric bypasses, subtotal esophagectomies, proximal gastrectomies, palliative bypasses, and total esophagectomies.
Eligibility Criteria
Patients undergoing esophagogastric surgeries requiring anastamosis.
You may qualify if:
- Patients undergoing any of the following surgeries at National University Hospital, Singapore between January 2001 and March 2019:
- Distal gastrectomies
- Total gastrectomies
- Bariatric gastric bypasses
- Subtotal esophagectomies
- Proximal gastrectomies
- Palliative bypasses
- Total esophagectomies
You may not qualify if:
- Under 21 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, 119074, Singapore
Related Publications (2)
Urschel JD. Esophagogastrostomy anastomotic leaks complicating esophagectomy: a review. Am J Surg. 1995 Jun;169(6):634-40. doi: 10.1016/s0002-9610(99)80238-4.
PMID: 7771633BACKGROUNDBruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. doi: 10.1046/j.0007-1323.2001.01829.x.
PMID: 11531861BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2022
First Posted
October 14, 2022
Study Start
November 28, 2019
Primary Completion
July 29, 2021
Study Completion
July 29, 2021
Last Updated
October 24, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share