The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery

The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery: Is it Safe to Feed the Patient?

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.

Study Overview

• Status: Completed
• Conditions: Anastomotic Leak
• Intervention / Treatment: Procedure: Esophageal and gastric resections requiring an anastomosis

Detailed Description

Anastomotic leak in esophagogastric surgery remains a diagnostic challenge despite advances in imaging techniques. All available modalities appear to have limited sensitivities and have significant false negatives. A high index of clinical suspicion continues to be the key element in the early diagnosis of esophagogastric anastomotic leaks. The incidence of anastomotic leak in esophagogastric surgeries is reported to range from 7-20% in various studies, and it is a major complication that increases hospital stay and mortality. It is important to identify these complications early to optimize the outcomes of these patients. There has been no study till date that examines the incidence of false negative results for anastomotic leak in esophagogastric surgeries. False negative findings may give surgeons a false sense of assurance in the patient's postoperative recovery, and escalation of oral intake may result in catastrophic complications and outcomes in these patients. This study seeks to identify the most sensitive modality in the diagnosis of esophagogastric anastomotic leaks in a retrospective series of patients.

• Study Type: Observational
• Enrollment (Actual): 592

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing esophagogastric surgeries requiring anastamosis.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Under 21 years of age

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Distal gastrectomies, total gastrectomies, bariatric gastric bypasses, subtotal esophagectomies, proximal gastrectomies, palliative bypasses, and total esophagectomies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): July 29, 2021

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: anastomotic leak; bariatric surgery; esophagogastric surgery; anastamosis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: 2019/00612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No