NCT05605080

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids
• Anal Fistula

Interventions

Type	Name	Description
DEVICE	Gelfoam	Use Gelfoam as a hemostatic agent after anal surgery.
OTHER	Bosmin gauze	Use bosmin gauze as a hemostatic agent after anal surgery.

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-10-30
• Completion: 2023-11-20
• First posted: 2022-11-04
• Last updated: 2023-11-22

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study