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

Taipei Medical University

Status: Completed

Conditions: Anal Fistula; Hemorrhoids

Treatments: Device: Gelfoam; Other: Bosmin gauze

Study type: Interventional

Funder types: Other

Identifiers

NCT05605080

N202209015

Details and patient eligibility

About

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

Full 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.

Enrollment: 292 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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292 participants in 2 patient groups

Gelfoam as hemostatic agent after surgery

Experimental group

Description:

Use Gelfoam as hemostatic agent after surgery.

Treatment:

Device: Gelfoam

Gauze with Bosmin as hemostatic agent after anal surgery

Active Comparator group

Description:

Use gauze with Bosmin as hemostatic agent after anal surgery

Treatment:

Other: Bosmin gauze