Comparison Study of the Effect of Enema in Anal Surgery

Study Overview
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Brief Summary
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To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

Detailed Description
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For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.

Official Title
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The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study

Conditions
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Hemorrhoids, Fistula

Intervention / Treatment
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* Procedure: enema
* Procedure: no enema


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group: enema<br>receiving enema at the night before anal surgery | Procedure: enema<br>* receiving enema at the night before anal surgery<br>|
| Active Comparator: Control Group: no enema<br>no enema before anal surgery | Procedure: no enema<br>* no enema before anal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | record max pain score(visual analog scale:0-10) each day | On postoperative day 0 to day 7 | 
| Consumption of analgesics | daily consumption of oral analgesics from post-operative day 0 to day 7 | On postoperative day 0 to day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of Urinary retention | patients requiring foley catheterization during hospital stay | On postoperative day 0 to day 7 | 
| First defecation after surgery | Time between first defecation and operation | On postoperative day 0 to day 7 |