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Comparison of efficacy and safety between MONOFIX®-PDO versus V-loc™ for resection bed suture during robot-assisted partial nephrectomy: A randomized control, multicenter, single-blinded trial

Comparison of efficacy and safety between MONOFIX®-PDO versus V-loc™ for resection bed suture during robot-assisted partial nephrectomy: A randomized control, multicenter, single-blinded trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006809
Enrollment
173
Registered
2021-12-06
Start date
2021-04-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

None listed

Interventions

Procedure/Surgery : Robot assisted laparoscopic partial nephrectomy - In a patient suspected of renal cell carcinoma, a robot is used to access the kidney under general anesthesia. After clamp renal a

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? 19-85 aged men and women ? Clinical stage T1-2N0M0 ? ECOG PS 0-1 ? Patients scheduled for robotic partial nephrectomy ? Patients who read consent and can voluntarily give consent

Exclusion criteria

Exclusion criteria: ? When it is expected that suture of the resected surface is not necessary after resection ? Those who have received pre-operative chemotherapy, targeted therapy, immunotherapy, etc. ? Previous intraperitoneal surgery or radiotherapy history ? Patients inadequate to participate in clinical trials due to comorbid diseases such as moderate to moderate cardiovascular disease, cerebrovascular disease, respiratory or liver disease ? Uncontrolled infectious disease ? Uncontrolled bleeding tendency ? Any other person judged by the investigator that participation in clinical trials is inappropriate

Design outcomes

Primary

MeasureTime frame
resection bed suture time

Secondary

MeasureTime frame
Total usage time of suture;Warm ischemic time;Total console time;estimated blood loss;Transfusion during or after surgery;Hemoglobin difference before and after surgery;Hemoglobin reduction on day 1 after surgery;Postoperative complications;Serious complications after surgery

Countries

Korea, Republic of

Contacts

Public ContactJanghee Han

Seoul National University Hospital

urohan@snu.ac.kr+82-2-2072-2428

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 6, 2026