The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery

Completed

• Conditions: Anastomotic Leak
• Interventions: Procedure: Esophageal and gastric resections requiring an anastomosis

• Registration Number: NCT05579912
• Lead Sponsor: National University Hospital, Singapore

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.

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 Timeline

• Study Start: 2019-11-28
• Primary Completion: 2021-07-29
• Study Completion: 2021-07-29
• Status Verified: 2022-10
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophagogastric Surgery Patients	Esophageal and gastric resections requiring an anastomosis	Patients who underwent esophageal and gastric resections requiring an anastomosis from January 2001 to March 2019

Primary Outcome Measures

Name	Time	Method
Anastomotic leak	Surgery day	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

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore