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

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05605080
• Other study ID #: N202209015
• Status: Completed
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: November 20, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Hemorrhoids
• Rectal Fistula

Intervention

Device:
• Gelfoam
Use Gelfoam as a hemostatic agent after anal surgery.

Other:
• Bosmin gauze
Use bosmin gauze as a hemostatic agent after anal surgery.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang-Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7.	0-7 days
Primary	Analgesic agent use	Daily consumption of oral analgesics from post-operative day 0 to day 7	0-7days
Secondary	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.	0-30 days
Secondary	Incidence of urinary retention	Urinary retention was defined as patients requiring Foley catheterization during the hospital stay	0-7 days
Secondary	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.	0-30 days