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

A phase II study Investigating the efficacy and safety of polyglycolic acid sheet for the prevention of infectious complication after laparoscopic surgery for gastric cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052210188
Enrollment
210
Registered
2022-03-08
Start date
2022-03-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraperitoneal infectious complications Intraperitoneal infectious complications

Interventions

affix around anastomosis, duodenal stump, and pancreas after lymph node dissection.
Primary Prevention
Prevention

Sponsors

Obama Kazutaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative infectious complications (Clavien-Dindo grade >=III)

Secondary

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

Contacts

Public ContactNobuaki Hoshino

Kyoto University Hospital

hoshinob@kuhp.kyoto-u.ac.jp+81-75-366-7595

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026