Patient DischargeNCT06737393
Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge
A study testing Backfill in people with Patient Discharge and Urinary Complication, run by University of Tennessee at 1 site in United States.
Trial summary
The investigators hypothesize that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the post-anesthesia care unit. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Discharge, Urinary Complication
- What is being tested?
- Backfill
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Jan 2026
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 to 80
- Undergoing planned laparoscopic hysterectomy as a day surgery procedure
Who cannot join
- Women younger than 18 or older than 80 years of age
- Undergoing a non-laparoscopic unplanned surgical procedure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Health Science Center
Memphis, Tennessee, 38103
Amira Wohabrebbi, PhD, 901-545-7453, awohabre@uthsc.edu
Annette Hickerson, RN, 901-448-4784, abpayne@uthsc.edu
About this study
Official title: Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: a Randomized Controlled Trial
The investigators hypothesize that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the post-anesthesia care unit.
Read the detailed description
This is a prospective, single-blinded, randomized clinical trials in which patients undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to have the bladder backfilled at the completion of the surgery prior to Foley catheter removal. If the patient is assigned to group A, 200 mL of room temperature, sterile normal saline will be instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively. If the patient is assigned to group B, the Foley catheter will be removed intraoperatively at completion of the procedure. The standard protocol is to use a 16F Foley catheter for gynecologic laparoscopy cases, and patients in both groups will receive the same size catheter. After surgery, time to discharge and time to void will be recorded.
- Conditions
- Patient Discharge, Urinary Complication
- Being tested
- Backfill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BackfillProcedure or surgery
Participants undergoing laparoscopic hysterectomy have the bladder filled with 200 mL saline prior to Foley removal at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Backfill | Experimental | Participants will receive 200 mL of room temperature, sterile normal saline instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively. Receives: Procedure: Backfill |
| No bladder filling | No intervention | Participants will have the Foley catheter removed intraoperatively at completion of the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge
The time to discharge for each participant, which will be defined as the length of time from surgery completion to discharge from the post-anesthesia care unit, will be recorded.
Measured: Within 3 days following surgery
Secondary outcomes (1)
Time to void
The time to void for each participant, which will be defined as the length of time from surgery completion to the time of participant's first voiding event, will be recorded.
Measured: Within 3 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient DischargeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737393
- Sponsor's protocol ID
- 24-09979-FB
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chao L, Mansuria S. Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):879-887. doi: 10.1097/AOG.0000000000003191.
PubMed 30969209Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.
PubMed 17980330Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.
PubMed 22984818Hariati H, Suza DE, Tarigan R. Risk Factors Analysis for Catheter-Associated Urinary Tract Infection in Medan, Indonesia. Open Access Maced J Med Sci. 2019 Sep 12;7(19):3189-3194. doi: 10.3889/oamjms.2019.798. eCollection 2019 Oct 15.
PubMed 31949514
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06737393
- Acronym / sponsor ID
- 24-09979-FB
- Conditions
- Patient Discharge, Urinary Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Dec 2024 (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.
The investigators hypothesize that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the post-anesthesia care unit.
Detailed description
This is a prospective, single-blinded, randomized clinical trials in which patients undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to have the bladder backfilled at the completion of the surgery prior to Foley catheter removal. If the patient is assigned to group A, 200 mL of room temperature, sterile normal saline will be instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively. If the patient is assigned to group B, the Foley catheter will be removed intraoperatively at completion of the procedure. The standard protocol is to use a 16F Foley catheter for gynecologic laparoscopy cases, and patients in both groups will receive the same size catheter. After surgery, time to discharge and time to void will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Backfill | Experimental | Procedure: BackfillParticipants will receive 200 mL of room temperature, sterile normal saline instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively. |
| No bladder filling | No intervention | –Participants will have the Foley catheter removed intraoperatively at completion of the procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 to 80
- Undergoing planned laparoscopic hysterectomy as a day surgery procedure
Key exclusion criteria (2 listed)
- Women younger than 18 or older than 80 years of age
- Undergoing a non-laparoscopic unplanned surgical procedure
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 |
|---|---|---|
| BackfillParticipants undergoing laparoscopic hysterectomy have the bladder filled with 200 mL saline prior to Foley removal at the end of surgery. | Procedure or surgery | Backfill |
Primary outcome
Time to discharge
Time frame: Within 3 days following surgery
The time to discharge for each participant, which will be defined as the length of time from surgery completion to discharge from the post-anesthesia care unit, will be recorded.
1 secondary outcome
Time to void
Time frame: Within 3 days following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 30969209Chao L, Mansuria S. Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):879-887. doi: 10.1097/AOG.0000000000003191.
- Background: PubMed 17980330Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.
- Background: PubMed 22984818Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.
- Background: PubMed 31949514Hariati H, Suza DE, Tarigan R. Risk Factors Analysis for Catheter-Associated Urinary Tract Infection in Medan, Indonesia. Open Access Maced J Med Sci. 2019 Sep 12;7(19):3189-3194. doi: 10.3889/oamjms.2019.798. eCollection 2019 Oct 15.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backfill in people with Patient Discharge and Urinary Complication, run by University of Tennessee 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 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discharge (time frame: Within 3 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737393, which also lists 4 linked publications.
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 17 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.