Clinical trial NCT05579912: The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery
Official title: The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery: Is it Safe to Feed the Patient?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak
Keywords: anastomotic leak
esophagogastric surgery
bariatric surgery
anastamosis
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 592
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing esophagogastric surgeries requiring anastamosis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic leak
timeFrame: Surgery day
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: 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.
citation: 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.