The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery

NCT ID: NCT05579912

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 592 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2021-07-29

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.

Conditions

Anastomotic Leak

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Esophagogastric Surgery Patients

Patients who underwent esophageal and gastric resections requiring an anastomosis from January 2001 to March 2019

Esophageal and gastric resections requiring an anastomosis

Intervention Type: PROCEDURE

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

Interventions

Esophageal and gastric resections requiring an anastomosis

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 7771633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11531861 (View on PubMed)

Other Identifiers

2019/00612

Identifier Type: -

Identifier Source: org_study_id