NCT04292496|Completed
Anastomotic Leak Testing in Gastrectomy
Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial
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Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial
Sponsor study identifier
interventional
148
1 country
1
Study Start
September 1, 2018
Actual (reported)Primary Completion
September 2, 2022
Actual (reported)Study Completion
March 13, 2023
Actual (reported)Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 13, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2018
Actual (reported)February 28, 2020
Actual (reported)March 3, 2020
Actual (reported)September 2, 2022
Actual (reported)March 13, 2023
Actual (reported)Anastomotic leakage
all patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis
2 months
Postoperative surgical complications
3 months
i) the integrity of the anastomosis can be directly observed under gastroscopy. ii) the distal of Roux limb was temporarily blocked, then the bowel of anastomosis was inflated by air, following 60 milliliter methylene blue.
Non intraoperative leak testing was performed intraoperatively.
After anastomosis was completed. We test the integrity of anastomosis intraoperatively.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yunhong Tian
Nanchong, Sichuan, 637000, China
Gao Z, Luo H, Ma L, Bai D, Qin X, Bautista M, Gong L, Peng Y, Hu J, Tian Y. Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial. Surg Endosc. 2023 Jul;37(7):5265-5273. doi: 10.1007/s00464-023-10025-w. Epub 2023 Mar 27.
148 participants (actual enrollment reported by the registry).
First Submitted
February 28, 2020
First Posted
March 3, 2020
Study Start
September 1, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 2, 2022
Actual (reported)Study Completion
March 13, 2023
Actual (reported)Last Updated
November 14, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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