se of biosynthetic material (MegaDerm) as reinforcing buttress material of anastomotic sites after gastric resectio
- Conditions
- Neoplasms
- Registration Number
- KCT0002715
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Patients who score 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) performance status scale
2) Patients who score 1, 2, or 3 on the ASA (American Society of Anesthesiology) score
3) Patients who were diagnosed with gastric adenocarcinoma preoperatively with endoscopic biopsy
4) Patients who were deemed fit for gastric resection surgery
5) Patients who were informed of the objective and course of the study and then gave their informed consent by providing their signature on the institutional review board-approved consent form
1) Patients who developed complications of gastric cancer (e.g. obstruction, perforation)
2) Patients who received neoadjuvant chemotherapy or radiotherapy for the gastric cancer
3) Patients who received surgery or radiation therapy for other cancers in the past five years
4) Vulnerable patients (patients who are incapable of making decisions for themselves, pregnant patients, patients planning pregnancy)
5) Patients who are or were enrolled in another clinical trial in the last six months
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients that experienced anastomotic leakage and hemorrhage and the severity of those complications as graded by the Clavien-Dindo classification system.
- Secondary Outcome Measures
Name Time Method aboratory values that are known to predict anastomotic leakage: C-reactive protein, NUn score;Calculated amount of blood loss using established formulas that employ hemoglobin and hematocrit levels