Hemorrhoids Clinical Trial
Official title:
The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study
Verified date | November 2023 |
Source | Taipei Medical University Shuang Ho Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.
Status | Completed |
Enrollment | 282 |
Est. completion date | October 31, 2023 |
Est. primary completion date | September 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy - Patients who underwent fistulotomy or fistulectomy Exclusion Criteria: - Emergency surgery - Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery - Complicated fistulectomy, e.g., requiring surgical drainage and seton placement - Other types of anal surgery, e.g., anal fissure and colorectal cancer - Liver cirrhosis - Coagulation dysfunction - Bedridden - Human immunodeficiency virus infection |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University Shuang-Ho Hospital | New Taipei City |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University Shuang Ho Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score | record max pain score(visual analog scale:0-10) each day | On postoperative day 0 to day 7 | |
Primary | Consumption of analgesics | daily consumption of oral analgesics from post-operative day 0 to day 7 | On postoperative day 0 to day 7 | |
Secondary | 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. | On postoperative day 0-30 | |
Secondary | Incidence of Urinary retention | patients requiring foley catheterization during hospital stay | On postoperative day 0 to day 7 | |
Secondary | First defecation after surgery | Time between first defecation and operation | On postoperative day 0 to day 7 |
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