Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
1 other identifier
interventional
292
1 country
1
Brief Summary
To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2022
CompletedFirst Posted
Study publicly available on registry
November 4, 2022
CompletedStudy Start
First participant enrolled
November 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2023
CompletedNovember 22, 2023
November 1, 2023
12 months
October 29, 2022
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Post-operative pain
Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.
0-7 days
Analgesic agent use
Daily consumption of oral analgesics from post-operative day 0 to day 7
0-7days
Secondary Outcomes (3)
Incidence of post-operative bleeding
0-30 days
Incidence of urinary retention
0-7 days
Incidence of surgical site infection
0-30 days
Study Arms (2)
Gelfoam as hemostatic agent after surgery
EXPERIMENTALUse Gelfoam as hemostatic agent after surgery.
Gauze with Bosmin as hemostatic agent after anal surgery
ACTIVE COMPARATORUse gauze with Bosmin as hemostatic agent after anal surgery
Interventions
Use Gelfoam as a hemostatic agent after anal surgery.
Use bosmin gauze as a hemostatic agent after anal surgery.
Eligibility Criteria
You may qualify if:
- Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
- Patients who undergo fistulectomy or fistulotomy are include.
You may not qualify if:
- Emergency operation
- Patients with colorectal cancer
- Liver cirrhosis
- Patients with coagulopathy
- Patients with HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University Shuang-Ho Hospital
New Taipei City, 235, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tung-Cheng Chang, MD, PHD
Taipei Medical University Shuang Ho Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Colorectal Surgery
Study Record Dates
First Submitted
October 29, 2022
First Posted
November 4, 2022
Study Start
November 7, 2022
Primary Completion
October 30, 2023
Study Completion
November 20, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- data is available as the study is complete and for 12 month period
- Access Criteria
- will be shared upon request
The datasets used in this study can be obtained from the investigator upon reasonable request.