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

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

Study Overview

• Status: Completed
• Conditions: Anal Fistula; Hemorrhoids
• Intervention / Treatment: Device: Gelfoam; Other: Bosmin gauze

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 Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Taipei Medical University Shuang-Ho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gelfoam as hemostatic agent after surgery; Use Gelfoam as hemostatic agent after surgery.	Device: Gelfoam; Use Gelfoam as a hemostatic agent after anal surgery.
Active Comparator: Gauze with Bosmin as hemostatic agent after anal surgery; Use gauze with Bosmin as hemostatic agent after anal surgery	Other: Bosmin gauze; Use bosmin gauze as a hemostatic agent after anal surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of urinary retention	Urinary retention was defined as patients requiring Foley catheterization during the hospital stay	0-7 days
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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Study Director: Tung-Cheng Chang, MD, PHD, Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: October 29, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula; Hemorrhoids; Hemostatics; Coagulants; Gelatin Sponge, Absorbable
• Other Study ID Numbers: N202209015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used in this study can be obtained from the investigator upon reasonable request.
• IPD Sharing Time Frame: data is available as the study is complete and for 12 month period
• IPD Sharing Access Criteria: will be shared upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes