Complications, PostoperativeNCT03812536
Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
A study testing No Void in people with Complications, Postoperative, run by Syed Husain at 1 site in United States.
Trial summary
The objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complications, Postoperative
- What is being tested?
- No Void
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 7 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old
- Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision
Who cannot join
- Age < 18 yo or > 80 yo
- Prisoners
- Pregnant Women
- Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not appropriate candidate for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
The objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits.
Read the detailed description
This study will be a prospective clinical trial, in which 100 anorectal surgery patients will be randomly assigned to a control (spontaneous void) or experimental (no void group). The spontaneous void group will include 50 patients who will be required to void spontaneously after anorectal surgeries. The no void group will be 50 patients who will be discharged home from the PACU once they meet ambulatory surgery center discharge criteria per hospital guidelines. Patients requiring anorectal surgeries will be consented to take part in the study during the preoperative outpatient office visit. A post-operative phone call will be made by designated study personnel to participants on post-op day 30 using a study questionnaire to assess re-admission and emergency room visits.
- Conditions
- Complications, Postoperative
- Being tested
- No Void
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No VoidOther
Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria.
| Study group | Role | What they receive |
|---|---|---|
| SOC Voiding Protocol | No intervention | Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home. |
| No Void Intervention | Experimental | Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously. Receives: Other: No Void |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU Time
This is the time patients in each arm spend in recovery. Measured as minutes elapsed between the end of surgery (surgery end time) and discharge from recovery room.
Measured: This measure will be recorded through the study period.
Secondary outcomes (1)
30-day Readmission
Number of patients readmitted in the 30-days period after surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start19 Jun 2018
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complications, PostoperativeStudies 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
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syed Husain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Syed Husain, Ohio State University
- Investigators
- Syed Husain, MBBS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812536
- Sponsor's protocol ID
- 2018H0208
- Status last verified
- Apr 2025
- First submitted
- 24 May 2018
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
- ClinicalTrials.gov ID
- NCT03812536
- Acronym / sponsor ID
- 2018H0208
- Conditions
- Complications, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Syed HusainUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits.
Detailed description
This study will be a prospective clinical trial, in which 100 anorectal surgery patients will be randomly assigned to a control (spontaneous void) or experimental (no void group). The spontaneous void group will include 50 patients who will be required to void spontaneously after anorectal surgeries. The no void group will be 50 patients who will be discharged home from the PACU once they meet ambulatory surgery center discharge criteria per hospital guidelines. Patients requiring anorectal surgeries will be consented to take part in the study during the preoperative outpatient office visit. A post-operative phone call will be made by designated study personnel to participants on post-op day 30 using a study questionnaire to assess re-admission and emergency room visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC Voiding Protocol | No intervention | –Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home. |
| No Void Intervention | Experimental | Other: No VoidPatients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years old
- Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision
Key exclusion criteria (4 listed)
- Age < 18 yo or > 80 yo
- Prisoners
- Pregnant Women
- Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not appropriate candidate for this study
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 |
|---|---|---|
| No VoidCurrently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria. | Other | No Void Intervention |
Primary outcome
PACU Time
Time frame: This measure will be recorded through the study period.
This is the time patients in each arm spend in recovery. Measured as minutes elapsed between the end of surgery (surgery end time) and discharge from recovery room.
1 secondary outcome
30-day Readmission
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Syed Husain, MBBS principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Void in people with Complications, Postoperative, run by Syed Husain at 1 site in United States.
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 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 13 Apr 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PACU Time (time frame: This measure will be recorded through the study period.). 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 13 Apr 2025.