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Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery

NCT ID: NCT05605080

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-11-20

Brief Summary

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To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.

Detailed Description

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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

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Hemorrhoids Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Gelfoam as hemostatic agent after surgery

Use Gelfoam as hemostatic agent after surgery.

Group Type EXPERIMENTAL

Gelfoam

Intervention Type DEVICE

Use Gelfoam as a hemostatic agent after anal surgery.

Gauze with Bosmin as hemostatic agent after anal surgery

Use gauze with Bosmin as hemostatic agent after anal surgery

Group Type ACTIVE_COMPARATOR

Bosmin gauze

Intervention Type OTHER

Use bosmin gauze as a hemostatic agent after anal surgery.

Interventions

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Gelfoam

Use Gelfoam as a hemostatic agent after anal surgery.

Intervention Type DEVICE

Bosmin gauze

Use bosmin gauze as a hemostatic agent after anal surgery.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tungcheng Chang, MD, PhD

Chief of Colorectal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tung-Cheng Chang, MD, PHD

Role: STUDY_DIRECTOR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University Shuang-Ho Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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N202209015

Identifier Type: -

Identifier Source: org_study_id