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

Not Applicable

Completed

• Conditions: Anal Fistula; Hemorrhoids
• Interventions: Device: Gelfoam; Other: Bosmin gauze

• Registration Number: NCT05605080
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-29
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-04
• Study Start: 2022-11-07
• Primary Completion: 2023-10-30
• Status Verified: 2023-11
• Study Completion: 2023-11-20
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelfoam as hemostatic agent after surgery	Gelfoam	Use Gelfoam as hemostatic agent after surgery.
Gauze with Bosmin as hemostatic agent after anal surgery	Bosmin gauze	Use gauze with Bosmin as hemostatic agent after anal surgery

Primary Outcome Measures

Name	Time	Method
Analgesic agent use	0-7days	Daily consumption of oral analgesics from post-operative day 0 to day 7
Post-operative pain	0-7 days	Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.

Secondary Outcome Measures

Name	Time	Method
Incidence of post-operative bleeding	0-30 days	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 surgical site infection	0-30 days	Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Incidence of urinary retention	0-7 days	Urinary retention was defined as patients requiring Foley catheterization during the hospital stay

Trial Locations

Locations (1)

Taipei Medical University Shuang-Ho Hospital; 🇨🇳 New Taipei City, Taiwan