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Evaluating the Effectiveness of Fibrinogen-Thrombin Collagen Patch in Reducing Anastomotic Leakage Post-Rectal Cancer Surgery: a prospective single arm multi center study

Evaluating the Effectiveness of Fibrinogen-Thrombin Collagen Patch in Reducing Anastomotic Leakage Post-Rectal Cancer Surgery: a prospective single arm multi center study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010383
Enrollment
267
Registered
2025-04-03
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-05-07

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

Conditions

None listed

Interventions

None listed

Sponsors

Chonnam National University Hospital Hwasun Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. Age 19 years or older and 85 years or younger B. Patients with rectal cancer requiring radical low anterior resection using DST anastomosis (within 10 cm from the anal verge) C. Subjects who voluntarily gave their consent D. Patients who received preoperative chemoradiation

Exclusion criteria

Exclusion criteria: A. Patients who underwent low anterior resection and underwent anastomosis other than the DST method B. Patients who underwent simultaneous anastomosis to other colon or small intestines in addition to the rectum during surgery C. Patients with suspected distant metastasis in preoperative examinations D. Patients with intestinal obstruction, intestinal perforation, or those requiring emergency surgery E. ECOG 3 or higher or ASA 4 or higher F. Pregnant or suspected pregnant G. Patients who did not voluntarily consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Expected leakage rate after TachoSil® application

Secondary

MeasureTime frame
Preexisting anastomotic leak rates in high-risk groups

Countries

Korea, Republic of

Contacts

Public ContactKIM Chang Hyun

Chonnam National University Hospital Hwasun Hospital

cksantiago8@gmail.com+82-61-379-7646

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026