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Comparison Study of the Effect of Enema in Anal Surgery

Primary Purpose

Hemorrhoids, Fistula

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
enema
no enema
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Medical University Shuang-Ho HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group: enema

Control Group: no enema

Arm Description

receiving enema at the night before anal surgery

no enema before anal surgery

Outcomes

Primary Outcome Measures

Pain score
record max pain score(visual analog scale:0-10) each day
Consumption of analgesics
daily consumption of oral analgesics from post-operative day 0 to day 7

Secondary Outcome Measures

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.
Incidence of Urinary retention
patients requiring foley catheterization during hospital stay
First defecation after surgery
Time between first defecation and operation

Full Information

First Posted
October 29, 2022
Last Updated
September 13, 2023
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05602987
Brief Title
Comparison Study of the Effect of Enema in Anal Surgery
Official Title
The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
September 10, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group: enema
Arm Type
Experimental
Arm Description
receiving enema at the night before anal surgery
Arm Title
Control Group: no enema
Arm Type
Active Comparator
Arm Description
no enema before anal surgery
Intervention Type
Procedure
Intervention Name(s)
enema
Intervention Description
receiving enema at the night before anal surgery
Intervention Type
Procedure
Intervention Name(s)
no enema
Intervention Description
no enema before anal surgery
Primary Outcome Measure Information:
Title
Pain score
Description
record max pain score(visual analog scale:0-10) each day
Time Frame
On postoperative day 0 to day 7
Title
Consumption of analgesics
Description
daily consumption of oral analgesics from post-operative day 0 to day 7
Time Frame
On postoperative day 0 to day 7
Secondary Outcome Measure Information:
Title
Incidence of surgical site infection
Description
Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Time Frame
On postoperative day 0-30
Title
Incidence of Urinary retention
Description
patients requiring foley catheterization during hospital stay
Time Frame
On postoperative day 0 to day 7
Title
First defecation after surgery
Description
Time between first defecation and operation
Time Frame
On postoperative day 0 to day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tung Cheng Chang, MD, PhD
Phone
+886-2-22490088
Ext
8123
Email
rotring810@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Yu Su, MD
Phone
+886-975422528
Email
andysu860102@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tung Cheng Chang, MD, PHD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University Shuang-Ho Hospital
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tung-Cheng Chang, PhD
Phone
+886-2-22490088
Ext
8123
Email
roussekimo@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets used in this study can be obtained from the investigator upon reasonable request.
IPD Sharing Time Frame
data is available as the study is complete and for 12 month period
IPD Sharing Access Criteria
will be shared upon request

Learn more about this trial

Comparison Study of the Effect of Enema in Anal Surgery

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