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Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial.
- Source :
-
Surgical endoscopy [Surg Endosc] 2023 Jul; Vol. 37 (7), pp. 5265-5273. Date of Electronic Publication: 2023 Mar 27. - Publication Year :
- 2023
-
Abstract
- Background: Anastomosis-related complications such as bleeding, leakage, and strictures, continue to be serious complications of gastric cancer surgery. Presently, these complications have yet to be reliably prevented. Here we design a comprehensive leak testing procedure which combines gastroscopy, air, and methylene blue (GAM) leak testing. We aimed to evaluated the efficacy and safety of the GAM procedure in patients with gastric cancer.<br />Methods: Patients aged 18-85 years without an unresectable factor as confirmed via CT were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital and were randomly assigned to two groups: intraoperative leak testing group (IOLT) and no intraoperative leak testing group (NIOLT). The primary endpoint was the incidence of postoperative anastomosis-related complications in the two groups.<br />Results: 148 patients were initially randomly assigned to the IOLT group (n = 74) and to the NIOLT group (n = 74) between September 2018 and September 2022. After exclusions, 70 remained in the IOLT group and 68 in the NIOLT group. In the IOLT group, 5 patients (7.1%) were found to have anastomotic defects intraoperatively, which included anastomotic discontinuity, bleeding, and strictures. The NIOLT group had a higher incidence of postoperative anastomotic leakage compared to the IOLT group: 4 patients (5.8%) vs 0 patients (0%), respectively. No GAM-related complications were observed.<br />Conclusion: The GAM procedure is an intraoperative leak test that can be performed safely and efficiently after a laparoscopic total gastrectomy. GAM anastomotic leak testing may effectively prevent technical defect-related anastomotic complications in patients with gastric cancer who undergo a gastrectomy.<br />Trial Registration: Clinical Trials.gov Identifier: NCT04292496.<br /> (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Subjects :
- Humans
Constriction, Pathologic surgery
Gastrectomy adverse effects
Gastrectomy methods
Laparoscopy adverse effects
Postoperative Complications epidemiology
Postoperative Complications etiology
Postoperative Complications prevention & control
Prospective Studies
Retrospective Studies
Anastomosis, Surgical adverse effects
Anastomotic Leak epidemiology
Anastomotic Leak etiology
Anastomotic Leak prevention & control
Stomach Neoplasms surgery
Stomach Neoplasms complications
Subjects
Details
- Language :
- English
- ISSN :
- 1432-2218
- Volume :
- 37
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Surgical endoscopy
- Publication Type :
- Academic Journal
- Accession number :
- 36971816
- Full Text :
- https://doi.org/10.1007/s00464-023-10025-w