Comparison Study of the Effect of Enema in Anal Surgery
The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study
1 other identifier
interventional
282
1 country
1
Brief Summary
To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedStudy Start
First participant enrolled
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedNovember 22, 2023
November 1, 2023
10 months
October 29, 2022
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Incidence of surgical site infection
On postoperative day 0-30
Incidence of Urinary retention
On postoperative day 0 to day 7
First defecation after surgery
On postoperative day 0 to day 7
Study Arms (2)
Study Group: enema
EXPERIMENTALreceiving enema at the night before anal surgery
Control Group: no enema
ACTIVE COMPARATORno enema before anal surgery
Interventions
Eligibility Criteria
You may qualify if:
- Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
- Patients who underwent fistulotomy or fistulectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University Shuang-Ho Hospital
New Taipei City, 235, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tung Cheng Chang, MD, PHD
Taipei Medical University Shuang Ho Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Colorectal Surgery
Study Record Dates
First Submitted
October 29, 2022
First Posted
November 2, 2022
Study Start
November 14, 2022
Primary Completion
September 10, 2023
Study Completion
October 31, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- data is available as the study is complete and for 12 month period
- Access Criteria
- will be shared upon request
The datasets used in this study can be obtained from the investigator upon reasonable request.