Efficacy and safety of polyglycolic acid sheet for the prevention of infectious complication after laparoscopic surgery for gastric cancer

Phase 2

• Conditions: Intraperitoneal infectious complications; Postoperative Complications

• Registration Number: JPRN-jRCTs052210188
• Lead Sponsor: Obama Kazutaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-08
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1)Pathologically diagnosed gastric adenocarcinoma
2)Laparoscopic/Robotic distal gastrectomy or total gastrectomy was performed
3)Clinical Stage I - III
4)Aged 18 - 85 years
5)Male and Female
6)ECOG Performance Status (PS) 0-1
7)Written informed consent was obtained

Exclusion Criteria

1)Distant metastasis, invasion to other organs, or spread to esophagus
2)Neoadjuvant chemotherapy
3)Past history of irradiation to upper abdomen
4)Past history of upper abdominal surgery
5)Combined surgery for other diseases other than cholecystectomy
6)Severe infectious disease or other comorbidities
7)Sever drug allergy
8)Immune-suppressing drug or steroid use
9)Peritoneal dialysis or Hemodialysis
10)Multiple antiplatelet/ anticoagulant drug use or warfarin use
11)Pregnancy or suspected pregnancy
12)Others

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative infectious complications (Clavien-Dindo grade >=III)

Secondary Outcome Measures

Name	Time	Method
Incidence of overall complication (Clavien-Dindo grade >=III)<br>Incidence of pancreatic fistula (Clavien-Dindo grade >=III)<br>Incidence of anastomotic leakage (Clavien-Dindo grade >=III)