Back to resultsHemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
Primary Purpose
Hemorrhoids, Anal Fistula
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Gelfoam
Bosmin gauze
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids
Eligibility Criteria
Inclusion Criteria: Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include. Patients who undergo fistulectomy or fistulotomy are include. Exclusion Criteria: Emergency operation Patients with colorectal cancer Liver cirrhosis Patients with coagulopathy Patients with HIV infection
Sites / Locations
- Taipei Medical University Shuang-Ho HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gelfoam as hemostatic agent after surgery
Gauze with Bosmin as hemostatic agent after anal surgery
Arm Description
Use Gelfoam as hemostatic agent after surgery.
Use gauze with Bosmin as hemostatic agent after anal surgery
Outcomes
Primary Outcome Measures
Post-operative pain
Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.
Analgesic agent use
Daily consumption of oral analgesics from post-operative day 0 to day 7
Secondary Outcome Measures
Incidence of post-operative bleeding
Postoperative delayed bleeding was defined as (1) when the bleeding required surgical intervention or (2) when hospital re-admission was warranted after patient discharge.
Incidence of urinary retention
Urinary retention was defined as patients requiring Foley catheterization during the hospital stay
Incidence of surgical site infection
Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Full Information
NCT ID
NCT05605080
First Posted
October 29, 2022
Last Updated
April 11, 2023
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05605080
Brief Title
Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
Official Title
Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.
Detailed Description
Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in Shuang Ho hospital. For these patients underwent surgical treatment, some surgeons used gauze with Bosmin for hemostasis and analgesia after surgery, and other surgeons used Gelfoam. These choices were often determined by surgeon's personal preference according to their experiences. Shuang Ho hospital has top three quantity of hemorrhoidectomy in Taiwan. So, a randomized controlled trial is conducted to evaluate the difference between hemostatic agents use after anal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Anal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
292 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gelfoam as hemostatic agent after surgery
Arm Type
Experimental
Arm Description
Use Gelfoam as hemostatic agent after surgery.
Arm Title
Gauze with Bosmin as hemostatic agent after anal surgery
Arm Type
Active Comparator
Arm Description
Use gauze with Bosmin as hemostatic agent after anal surgery
Intervention Type
Device
Intervention Name(s)
Gelfoam
Intervention Description
Use Gelfoam as a hemostatic agent after anal surgery.
Intervention Type
Other
Intervention Name(s)
Bosmin gauze
Intervention Description
Use bosmin gauze as a hemostatic agent after anal surgery.
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.
Time Frame
0-7 days
Title
Analgesic agent use
Description
Daily consumption of oral analgesics from post-operative day 0 to day 7
Time Frame
0-7days
Secondary Outcome Measure Information:
Title
Incidence of post-operative bleeding
Description
Postoperative delayed bleeding was defined as (1) when the bleeding required surgical intervention or (2) when hospital re-admission was warranted after patient discharge.
Time Frame
0-30 days
Title
Incidence of urinary retention
Description
Urinary retention was defined as patients requiring Foley catheterization during the hospital stay
Time Frame
0-7 days
Title
Incidence of surgical site infection
Description
Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Time Frame
0-30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
Patients who undergo fistulectomy or fistulotomy are include.
Exclusion Criteria:
Emergency operation
Patients with colorectal cancer
Liver cirrhosis
Patients with coagulopathy
Patients with HIV infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tungcheng Chang, MD, PHD
Phone
+886-2-22490088
Ext
8123
Email
rotring810@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tung-Cheng Chang, MD, PHD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University Shuang-Ho Hospital
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tung-Cheng Chang, PhD
Phone
+886-2-22490088
Ext
8123
Email
roussekimo@yahoo.com.tw
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets used in this study can be obtained from the investigator upon reasonable request.
IPD Sharing Time Frame
data is available as the study is complete and for 12 month period
IPD Sharing Access Criteria
will be shared upon request
Learn more about this trial
Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
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