Hemorrhoids, Anal Fistula
Conditions
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.
Interventions
DEVICEGelfoam
Use Gelfoam as a hemostatic agent after anal surgery.
OTHERBosmin gauze
Use bosmin gauze as a hemostatic agent after anal surgery.
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 0-7 days | Record maximum pain score (visual analog scale, 0-10) from post-operative day 0 to day 7. |
| Analgesic agent use | 0-7days | Daily consumption of oral analgesics from post-operative day 0 to day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 urinary retention | 0-7 days | Urinary retention was defined as patients requiring Foley catheterization during the hospital stay |
| 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. |
Countries
Taiwan
Outcome results
None listed