Efficacy of Polyglycolic Acid Sheet on the clinical course of anastomotic leakage after gastrectomy in patients with gastric cancer

JRCT ID: jRCTs042210090

Registered date:28/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer, gastric neuroendocrine tumor
• Date of first enrollment: 03/02/2022
• Target sample size: 320
• Study type: Interventional
• Intervention(s): usage of Polyglycolic Acid Sheet in gastrectomy

Outcome(s)

• Primary Outcome: The maximum value of amylases of drain discharge

Secondary Outcome

Ttransition of value of amylases of drain discharge
Iincidence of pancreatic fistula
Incidence of intra-abdominal abscess
White blood cell count
Value of C-reactive protein (CRP)
Incidence of postoperative complication
Duration of antibiotic agents administration
Duration of abdominal drainage
Usage of octreotide
Duration of hospital stay.
Incidence of bleeding in abdominal cavity
Mortality
Incidence of reoperation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who were planned to undergo curative gastrectomy with D1+ or more lymp node dissection.
Aged 20 years or mroe at the time of registration and written informed consent.

Exclude criteria

History of gastrectomy.
History of pancreatectomy.
Active infection in abdominal cavity.
Tumor invasion to pancreas.
Patients who were planned pancreatectomy.
Patients who were planned splenectomy.
Emergency surgery.
Patients who were suspected to have allergy to polyglycolic acid.
Patients who were planned robotic assisted gastrectomy.
Ineligible for the study at the physician's assessment.

Related Information

• Primary Sponsor: Kodera Yasuhiro