The effect of carboxymetyl starch (Oozfix) on preventing postoperative complication after gastrectomy: Single-center, non-inferiority, open-label randomized trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007511

Enrollment

180

Registered

2022-07-18

Start date

2022-07-04

Completion date

Unknown

Last updated

2022-09-20

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

Conditions

None listed

Interventions

Medical Device : Name : Oozfix Contents : Carboxymethy starch Dose: 5g Application : Directly apply evenly at the suprapancreatic surgical bed after gastrectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Gastric cancer patient who underwent radical gastrectomy at Bucheon St. Mary Hospital 2) Patient's Age is above 19 and less than 80 3) ECOG performance score : 0~2

Exclusion criteria

Exclusion criteria: 1) Patient who underwent emergent gastrectomy 2) Patient who requires palliative gastrectomy due to advanced or metastatic carcinoma 3) Patient who requires operation due to other malignancy other than adenocrcinoma 4) Patient who underwent emergent gastrectomy or pancreatectomy before this study 5) Patient who underwent chemoradiation 6) Patient who took anticoagulants or with coagulopathy

Design outcomes

Primary

Measure	Time frame
Ratio of patient who suffers from pancreatic fistula	—

Secondary

Measure	Time frame
Ratio of patient who suffers from postoperative bleeding	—

Countries

Korea, Republic of

Contacts

Public ContactHayemin Lee

The Catholic University of Korea

hymin@catholic.ac.kr+82-32-340-2258

Outcome results