Fluid RestrictionNCT04459039
Fluid Restriction After Stapled Hemorrhoidopexy
A study testing 1000 mL 0.9% sterile saline and 250 mL 0.9% sterile saline in people with Fluid Restriction, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Restriction
- What is being tested?
- 1000 mL 0.9% sterile saline and 250 mL 0.9% sterile saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2018to 1 Feb 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gr. III-IV hemorrhoids paitents
Who cannot join
- Age<20 or >80
- Allergy to NSAID or opoids
- Impaired renal function
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, National Defense Medical Center
Taipei
About this study
Official title: Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial
BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain.
PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.
- Conditions
- Fluid Restriction
- Being tested
- 1000 mL 0.9% sterile saline, 250 mL 0.9% sterile saline
- Keywords
- Stapled hemorrhoidopexy, Fluid restriction, Urinary retention
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1000 mL 0.9% sterile salineDrug
Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
250 mL 0.9% sterile salineDrug
Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Fluid restriction | Experimental | Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously. Receives: Drug: 1000 mL 0.9% sterile saline |
| Non-fluid restriction | Placebo comparator | Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously Receives: Drug: 250 mL 0.9% sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
first urination
the time to first urination after surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Feb 2018
- Primary completion1 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid RestrictionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Chiao Cheng, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459039
- Sponsor's protocol ID
- 2-106-05-063
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do We Need Fluid Restriction After Stapled Hemorrhoidopexy? A Pilot, Double-Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04459039
- Acronym / sponsor ID
- 2-106-05-063
- Conditions
- Fluid Restriction
- Keywords
- Stapled hemorrhoidopexy, Fluid restriction, Urinary retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 7 Jul 2020 (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.
BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain.
PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid restriction | Experimental | Drug: 1000 mL 0.9% sterile salineWithin 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously. |
| Non-fluid restriction | Placebo comparator | Drug: 250 mL 0.9% sterile salineWithin 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gr. III-IV hemorrhoids paitents
Key exclusion criteria (4 listed)
- Age<20 or >80
- Allergy to NSAID or opoids
- Impaired renal function
- Pregnant or breast feeding
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 |
|---|---|---|
| 1000 mL 0.9% sterile salineWithin 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously. | Drug | Fluid restriction |
| 250 mL 0.9% sterile salineWithin 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously. | Drug | Non-fluid restriction |
Primary outcome
first urination
Time frame: 1 day
the time to first urination after surgery
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 7 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1000 mL 0.9% sterile saline and 250 mL 0.9% sterile saline in people with Fluid Restriction, run by Tri-Service General Hospital (TSGH) 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 1 inclusion and 4 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 7 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
first urination (time frame: 1 day). 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 7 Jul 2020.