NCT05579912

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

1.7 years

First QC Date

October 11, 2022

Last Update Submit

October 21, 2022

Conditions

Keywords

anastomotic leakesophagogastric surgerybariatric surgeryanastamosis

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

Procedure: Esophageal and gastric resections requiring an anastomosis

Interventions

Distal gastrectomies, total gastrectomies, bariatric gastric bypasses, subtotal esophagectomies, proximal gastrectomies, palliative bypasses, and total esophagectomies.

Esophagogastric Surgery Patients

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 7771633BACKGROUND
  • Bruce 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

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

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

Locations