Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.

Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy. - Harmonic scalpel for open gastrectomy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003303

Enrollment

230

Registered

2010-03-09

Start date

2010-03-01

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

Gastric cancer

Interventions

Open gastrectomy with ultrasonically activated coagulating shears Open gastrectomy without ultrasonically activated coagulating shears

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Primary treatment for histologically proven adenocarcinoma of the stomach. 2)Indication for open gastrectomy under Guidelines for Diagnosis and Treatment of Carcinoma of the Stomach(Edited by the Japanese Gasric Cancer Society). 3)Clinical stage IA to IIIB by preoperative examinations. 4)Age 20 to 90 years old. 5)Performance status (ECOG) 0 or 1. 6)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Cancer of gastric remnant. 2)Intention of laparoscopic gastrectomy. 3)Prescribed antiplatelet and anticoagulant agent which needs alternative administration of heparin in the perioperative period. 4)Non curative factors proven by preoperative examinations. 5)Preoperative chemotherapy. 6)Synchronous malignancies other than carcinoma in situ of cervical cancer or focal cancer in adenoma of colorectal cancer. 7)Metachronous malignancies within 5 years or with tumor recurrence. 8)Severe respiratory dysfunction. 9)History of myocardinal infarction within 6 months before surgery. 10)Liver cirrhosis or active hepatitis. 11)Chronic renal failure with hemodialysis. 12)Uncontrolled diabetes mellitus (HbA1c 9.0 or more). 13)Other unfeasible factors to perform study safely approved by attending surgeon.

Design outcomes

Primary

Measure	Time frame
Operative time from skin incision to resection of gastric specimen	—

Secondary

Measure	Time frame
total operative time, operative blood loss, postoperative complications, postoperative hospital stay, medical costs.	—

Countries

Japan

Contacts

Public ContactShuji Takiguchi

Graduate School of Medicine, Osaka University Department of Gastroenterological Surgery

stakiguchi@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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