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OpenTrials
Completed

NCT Number: NCT05579912

The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery

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.

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Key information

Conditions

Anastomotic Leak Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal and gastric resections requiring an anastomosis

Procedure

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

Primary outcomes

  1. Anastomotic leak

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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