Hemorrhoids Clinical Trial
— THDOfficial title:
Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy for 3rd and 4th Degree Hemorrhoids in at Least Three Quadrants: A Prospective Randomized Control Pilot Study.
Verified date | October 2012 |
Source | Stony Brook University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to compare the frequency and severity of postoperative( after surgery) pain between two surgical techniques for treating severe hemorrhoids. The two techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical excision (removal) of the hemorrhoids
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients visiting colorectal outpatient office at Stony Book Medical Center, with the diagnosis of 3rd or 4th degree hemorrhoids requiring hemorrhoidectomy will be invited to participate in this study. The diagnosis of hemorrhoids will be established by a colorectal surgeon based on following criteria: 1. physical exam 2. anoscopy or proctoscopy Exclusion Criteria: 1. first and second degree hemorrhoids 2. recurrent hemorrhoids after previous surgical treatment 3. history of HIV 4. history of inflammatory bowel disease 5. inability to give informed consent due to mental disability 6. age younger than 18 7. history of colon, rectal or anal cancer 8. thrombosed hemorrhoids 9. pregnant women 10. non English speaking patients |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | State University Hospital Medical Center | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
Stony Brook University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post operative pain | Patient reports pain levels at 14 days post surgery | 14 days | No |
Secondary | complications | Complications involving hospital visit. | 30 days | No |
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