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To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gelfoam as hemostatic agent after surgery | Experimental | Use Gelfoam as hemostatic agent after surgery. |
|
| Gauze with Bosmin as hemostatic agent after anal surgery | Active Comparator | Use gauze with Bosmin as hemostatic agent after anal surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelfoam | Device | Use Gelfoam as a hemostatic agent after anal surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tung-Cheng Chang, MD, PHD | Taipei Medical University Shuang Ho Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Shuang-Ho Hospital | New Taipei City | 235 | Taiwan |
The datasets used in this study can be obtained from the investigator upon reasonable request.
data is available as the study is complete and for 12 month period
will be shared upon request
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Bosmin gauze | Other | Use bosmin gauze as a hemostatic agent after anal surgery. |
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |