HemorrhoidsNCT05605080
Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
A study testing Gelfoam and Bosmin gauze in people with Hemorrhoids and Anal Fistula, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hemorrhoids, Anal Fistula
- What is being tested?
- Gelfoam and Bosmin gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Nov 2022to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
- Patients who undergo fistulectomy or fistulotomy are include.
Who cannot join
- Emergency operation
- Patients with colorectal cancer
- Liver cirrhosis
- Patients with coagulopathy
- Patients with HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.
Read the 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.
- Conditions
- Hemorrhoids, Anal Fistula
- Being tested
- Gelfoam, Bosmin gauze
- Medical subject headings
- Hemorrhoids, Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelfoamDevice
Use Gelfoam as a hemostatic agent after anal surgery.
Bosmin gauzeOther
Use bosmin gauze as a hemostatic agent after anal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Gelfoam as hemostatic agent after surgery | Experimental | Use Gelfoam as hemostatic agent after surgery. Receives: Device: Gelfoam |
| Gauze with Bosmin as hemostatic agent after anal surgery | Active comparator | Use gauze with Bosmin as hemostatic agent after anal surgery Receives: Other: Bosmin gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.
Measured: 0-7 days
Analgesic agent use
Daily consumption of oral analgesics from post-operative day 0 to day 7
Measured: 0-7days
Secondary outcomes (3)
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.
Measured: 0-30 days
Incidence of urinary retention
Urinary retention was defined as patients requiring Foley catheterization during the hospital stay
Measured: 0-7 days
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.
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start7 Nov 2022
- Primary completion30 Oct 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tungcheng Chang, MD, PhD, Taipei Medical University Shuang Ho Hospital
- Investigators
- Tung-Cheng Chang, MD, PHD, Study director, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605080
- Sponsor's protocol ID
- N202209015
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The datasets used in this study can be obtained from the investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery
- ClinicalTrials.gov ID
- NCT05605080
- Acronym / sponsor ID
- N202209015
- Conditions
- Hemorrhoids, Anal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelfoam as hemostatic agent after surgery | Experimental | Device: GelfoamUse Gelfoam as hemostatic agent after surgery. |
| Gauze with Bosmin as hemostatic agent after anal surgery | Active comparator | Other: Bosmin gauzeUse gauze with Bosmin as hemostatic agent after anal surgery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
- Patients who undergo fistulectomy or fistulotomy are include.
Key exclusion criteria (5 listed)
- Emergency operation
- Patients with colorectal cancer
- Liver cirrhosis
- Patients with coagulopathy
- Patients with HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GelfoamUse Gelfoam as a hemostatic agent after anal surgery. | Device | Gelfoam as hemostatic agent after surgery |
| Bosmin gauzeUse bosmin gauze as a hemostatic agent after anal surgery. | Other | Gauze with Bosmin as hemostatic agent after anal surgery |
Primary outcome
Post-operative pain
Time frame: 0-7 days
Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.
Analgesic agent use
Time frame: 0-7days
Daily consumption of oral analgesics from post-operative day 0 to day 7
3 secondary outcomes
Incidence of post-operative bleeding
Time frame: 0-30 days
Incidence of urinary retention
Time frame: 0-7 days
Incidence of surgical site infection
Time frame: 0-30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. The datasets used in this study can be obtained from the investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tung-Cheng Chang, MD, PHD study director
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelfoam and Bosmin gauze in people with Hemorrhoids and Anal Fistula, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 0-7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.