NCT06277908|Unknown
Postoperative Morbidity and Mortality After Gastric Cancer Surgery
GASTROSTAT
90-day Postoperative Morbidity and Mortality After Elective Surgery for Gastric Cancer
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GASTROSTAT
90-day Postoperative Morbidity and Mortality After Elective Surgery for Gastric Cancer
Sponsor study identifier
observational
700
1 country
9
Study Start
March 18, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 18, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
February 8, 2024
Actual (reported)February 26, 2024
Actual (reported)March 18, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 18, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
the type of complications and the incidence of it
the types of complication is classified into as follows: anastomotic leak, postoperative bleeding requiring invasive treatment, other complications requiring re-intervention or other invasive procedure, postoperative bowel obstruction, postoperative pancreatic fistula, duodenal leak, gastrostasis, postoperative pancreatitis, postoperative bowel perforation or necrosis, non-surgical infections, pleural effusion requiring drainage, respiratory failure requiring reintubation, acute renal failure requiring hemofiltration/dialysis, need for prolonged intubation, need for tracheostomy, need for cardiopulmonary resuscitation, pulmonary embolism, pneumothorax requiring treatment, myocardial infarction, acute myocardial failure, cardiac dysrhythmia requiring invasive treatment, stroke, acute liver dysfunction, other complications. Each complication will be graded according to Clavien-Dindo classification. Re-admission or visiting emergency room will be checked and recorded.
within 90 days after operation
Patients who suffered from any type of morbidity after surgery
Patients who did not suffer from any type of morbidity after surgery
Total, distal or proximal gastrectomy via open, laparoscopic or robotic approach
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All consecutive patients with primary gastric malignancy (including Siewert III) undergoing elective surgery with curative intent (either total or partial gastrectomy) via open, laparoscopic or robotic approach between 18th March 2024 and 18th September 2024.
A.S. Loginov Moscow Clinical Scientific Center
Moscow, Russia
A.Tsyb Medical Radiological Research Centre
Moscow, Russia
I.M. Sechenov First Moscow State Medical University
Moscow, Russia
P.Herzen Moscow Oncological Research Institute
Moscow, Russia
Petrovsky National Research Centre of Surgery
Andrey Ryabov, MD, PhD
P.Herzen Moscow Oncological Research Institute
Vladimir Khomyakov, MD, PhD
P.Herzen Moscow Oncological Research Institute
Nuriddin Abdulkhakimov, MD, PhD
P.Herzen Moscow Oncological Research Institute
Pavel Smirnov
P.Herzen Moscow Oncological Research Institute
First Submitted
February 8, 2024
First Posted
February 26, 2024
Study Start
March 18, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Microbiota in Gastric Cancer by Gastric Mucosal Brushing
Contact the study team to confirm eligibility.
Moscow, Russia
Vishnevsky National Medical Research Center of Surgery
Moscow, Russia
Nizhny Novgorod Regional Clinical Oncological Dispensary
Nizhny Novgorod, Russia
National Medical Research Centre for Oncology
Rostov-on-Don, Russia
Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia
September 18, 2024
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 26, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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