- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053542
The Necessity of Preoperative Bowel Preparation
The Necessity of Preoperative Bowel Preparation for Hemorrhoidectomy: A Single-Center Retrospective Comparative Study
Study Overview
Detailed Description
Hemorrhoidectomy is an effective treatment for high-grade hemorrhoids and is recommended in patients with grade III-IV hemorrhoids. Common hemorrhoidectomy approaches include stapled hemorrhoidopexy and conventional procedures, such as Ferguson hemorrhoidectomy and Milligan-Morgan hemorrhoidectomy. Conventional techniques produce a lower recurrence rate, whereas stapled hemorrhoidopexy is associated with fewer postoperative complications and shorter recovery time.
Common complications after hemorrhoidectomy include urinary retention, pain, and delayed hemorrhage. Surgical site infection is a rare complication after hemorrhoid excision. Traditional opinions held that preoperative bowel preparation (PBP) reduces fecal mass and bacterial count in the bowel lumen, minimizing the risk of infective and anastomotic complications. However, a study that evaluated intramucosal bacterial count demonstrated that PBP does not reduce the colon bacterial count. A randomized control trial (RCT) evaluating the effect of PBP before colorectal surgery suggested that the procedure can be omitted. However, another RCT with 79 participants revealed that bowel preparation before anorectal surgery can result in less pain during the first postoperative defecation. A meta-analysis with 36 studies concluded that PBP before elective colorectal surgery does not affect the postoperative complication rate. On the contrary, the necessity of PBP before anorectal surgeries remains unreported. The choice of whether PBP has to be performed is often the surgeon's preference. It may be challenging for physicians to determine the appropriate decision of PBP before hemorrhoidectomy to reduce postoperative complications while minimizing patient discomfort.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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New Taipei City, Taiwan, 235
- Taipei Medical University Shuang-Ho Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients underwent hemorrhoidectomy
Exclusion Criteria:
- Patients who had received emergent or other anorectal surgery, such as fistulectomy, were excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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With or without enema before operation
Patients who had received pre-operative bowel preparation(PBP) were identified using electronic medical records.
Patients prescribed an enema solution (EVAC enema 118 mL/bot, Purzer Pharmaceutical Co., Ltd) before surgery were allocated to the PBP group.
Patients who received no PBP were allocated to none PBP group.
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Patients in the PBP group underwent a cleansing enema procedure with a solution of monosodium phosphate and disodium phosphate (EVAC enema 118 mL/bot, Purzer Pharmaceutical Co., Ltd) before hemorrhoidectomy, whereas patients in the non-PBP group skipped the procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-operative pain and
Time Frame: 4 weeks
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A numerical rating scale (NRS) was used for measuring daily postoperative pain, where 0 represented no pain and 10 represented the worst pain ever experienced.
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4 weeks
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Post-operative oral analgesic use.
Time Frame: 4 weeks
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The daily dose of oral analgesics was recorded to represent patients' dependence on medicine for postoperative pain control.
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4 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202009024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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