Clinical Trials Directory

Trials / Completed

CompletedNCT05579912

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?

Status
Completed
Phase
Study type
Observational
Enrollment
592 (actual)
Sponsor
National University Hospital, Singapore · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEsophageal and gastric resections requiring an anastomosisDistal gastrectomies, total gastrectomies, bariatric gastric bypasses, subtotal esophagectomies, proximal gastrectomies, palliative bypasses, and total esophagectomies.

Timeline

Start date
2019-11-28
Primary completion
2021-07-29
Completion
2021-07-29
First posted
2022-10-14
Last updated
2022-10-24

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT05579912. Inclusion in this directory is not an endorsement.