HemorrhoidsNCT05602987
Comparison Study of the Effect of Enema in Anal Surgery
A study testing enema and no enema in people with Hemorrhoids and Fistula, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hemorrhoids, Fistula
- What is being tested?
- enema and no enema
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Nov 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
- Patients who underwent fistulotomy or fistulectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study
To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.
Read the 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.
- Conditions
- Hemorrhoids, Fistula
- Being tested
- enema, no enema
- Medical subject headings
- Hemorrhoids, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enemaProcedure or surgery
receiving enema at the night before anal surgery
no enemaProcedure or surgery
no enema before anal surgery
| Study group | Role | What they receive |
|---|---|---|
| Study Group: enema | Experimental | receiving enema at the night before anal surgery Receives: Procedure: enema |
| Control Group: no enema | Active comparator | no enema before anal surgery Receives: Procedure: no enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
record max pain score(visual analog scale:0-10) each day
Measured: On postoperative day 0 to day 7
Consumption of analgesics
daily consumption of oral analgesics from post-operative day 0 to day 7
Measured: On postoperative day 0 to day 7
Secondary outcomes (3)
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.
Measured: On postoperative day 0-30
Incidence of Urinary retention
patients requiring foley catheterization during hospital stay
Measured: On postoperative day 0 to day 7
First defecation after surgery
Time between first defecation and operation
Measured: On postoperative day 0 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start14 Nov 2022
- Primary completion10 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tungcheng Chang, MD, PhD, Taipei Medical University Shuang Ho Hospital
- Investigators
- Tung Cheng Chang, MD, PHD, Study director, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602987
- Sponsor's protocol ID
- N202209016
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used in this study can be obtained from the investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05602987
- Acronym / sponsor ID
- N202209016
- Conditions
- Hemorrhoids, Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group: enema | Experimental | Procedure: enemareceiving enema at the night before anal surgery |
| Control Group: no enema | Active comparator | Procedure: no enemano enema before anal surgery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
- Patients who underwent fistulotomy or fistulectomy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enemareceiving enema at the night before anal surgery | Procedure or surgery | Study Group: enema |
| no enemano enema before anal surgery | Procedure or surgery | Control Group: no enema |
Primary outcome
Pain score
Time frame: On postoperative day 0 to day 7
record max pain score(visual analog scale:0-10) each day
Consumption of analgesics
Time frame: On postoperative day 0 to day 7
daily consumption of oral analgesics from post-operative day 0 to day 7
3 secondary outcomes
Incidence of surgical site infection
Time frame: On postoperative day 0-30
Incidence of Urinary retention
Time frame: On postoperative day 0 to day 7
First defecation after surgery
Time frame: On postoperative day 0 to day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. The datasets used in this study can be obtained from the investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tung Cheng Chang, MD, PHD study director
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enema and no enema in people with Hemorrhoids and Fistula, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: On postoperative day 0 to day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.