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

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

Detailed Description
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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.

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

Conditions
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Hemorrhoids, Anal Fistula

Intervention / Treatment
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* Device: Gelfoam
* Other: Bosmin gauze


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gelfoam as hemostatic agent after surgery<br>Use Gelfoam as hemostatic agent after surgery. | Device: Gelfoam<br>* Use Gelfoam as a hemostatic agent after anal surgery.<br>|
| Active Comparator: Gauze with Bosmin as hemostatic agent after anal surgery<br>Use gauze with Bosmin as hemostatic agent after anal surgery | Other: Bosmin gauze<br>* Use bosmin gauze as a hemostatic agent after anal surgery.<br>|

What is the study measuring?
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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 |