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

JRCT ID: jRCTs052210188

Registered date:08/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Intraperitoneal infectious complications
• Date of first enrollment: 25/03/2022
• Target sample size: 210
• Study type: Interventional
• Intervention(s): Polyglycolic acid sheet; affix around anastomosis, duodenal stump, and pancreas after lymph node dissection.

Outcome(s)

• Primary Outcome: Incidence of intraoperative infectious complications (Clavien-Dindo grade >=III)

Secondary Outcome

Incidence of overall complication (Clavien-Dindo grade >=III)
Incidence of pancreatic fistula (Clavien-Dindo grade >=III)
Incidence of anastomotic leakage (Clavien-Dindo grade >=III)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Obama Kazutaka
• Source(s) of Monetary Support: Gunze Limited