Postoperative Bladder Testing After Total Laparoscopic Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2018-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to determine if backfilling the bladder immediately post-operatively, prior to removal of the foley catheter, in patients undergoing same-day total laparoscopic hysterectomy will hasten time to first spontaneous void and time to discharge

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge

NCT06737393

Patient Discharge Urinary Complication

RECRUITING NA

Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial

NCT03141372

Urinary Retention Voiding Disorders

COMPLETED NA

Post Hysterectomy Benefits of Retained Cystoscopy Fluid

NCT03646136

Urinary Retention

COMPLETED NA

The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial

NCT04487600

Minimally Invasive Surgical Procedure Hysterectomy Urinary Retention

COMPLETED NA

The Effect of Partial Bladder Filling on Post-operative Time to Void in Minimally Invasive Gynecologic Procedures

NCT02741531

Hysterectomy Myomectomy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In recent years, a paradigm shift from traditional perioperative care models to "Enhanced Recovery After Surgery (ERAS)" has taken place across a wide range of surgical subspecialties including minimally-invasive gynecologic surgery. Many gynecologic procedures that once required hospital admission are now being performed as outpatient procedures. To optimize same-day discharge through the ERAS pathways, protocols call for early removal of urinary catheters following gynecologic surgery. Studies in urogynecologic literature have shown that a backfill-assisted voiding trial is superior to a spontaneous voiding trial in patients undergoing transvaginal surgery. However, there are limited studies published in literature focusing on minimally invasive gynecologic procedures, specifically laparoscopic hysterectomies. A successful spontaneous voiding trial is usually a postoperative criteria prior to discharge after same-day total laparoscopic hysterectomy. Through this randomized controlled trial, the investigators aim to compare two techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy. This study would provide valuable data on improved measures for predicting voiding efficiency, time to first void, and time to discharge for patients undergoing same-day total laparoscopic hysterectomies. Ultimately, the investigators predict that backfilling the bladder immediately postoperatively, prior to removal of the foley catheter, will hasten time to first spontaneous void and reduce the amount of time spent in the recovery room.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Hysterectomy Enhanced Recovery After Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participants will be randomly assigned to one of two groups - A) bladder backfilled group or B) control group. This is a blinded study and the participant will not know which group they were assigned to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bladder Backfilled group

Subjects randomized to the bladder backfilled group (Group A) will have 200 mL of normal saline instilled into their bladders prior to removal of the foley catheter. The foley catheter will subsequently be removed

Group Type EXPERIMENTAL

InstilIing normal saline into bladder

Intervention Type PROCEDURE

Backfilling the bladder with 200 mL of normal saline immediately postoperatively, prior to foley catheter removal, after same-day total laparoscopic hysterectomy can potentially increase time to first spontaneous void and time to discharge.

Removal of foley catheter

Intervention Type PROCEDURE

Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy

Control group

Subjects randomized to the control group (Group B) will just have their foley catheters removed at the end of the surgery. This is routinely done post-operatively after routine gynecologic surgery.

Group Type PLACEBO_COMPARATOR

Removal of foley catheter

Intervention Type PROCEDURE

Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

InstilIing normal saline into bladder

Backfilling the bladder with 200 mL of normal saline immediately postoperatively, prior to foley catheter removal, after same-day total laparoscopic hysterectomy can potentially increase time to first spontaneous void and time to discharge.

Intervention Type PROCEDURE

Removal of foley catheter

Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged 18-75 years of age
* Ability to comprehend English
* Women undergoing same-day laparoscopic hysterectomy through the Enhanced Recovery after Surgery (ERAS) protocol at Magee-Womens Hospital (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy)

Exclusion Criteria

* Women who are unable to give informed consent
* History of prior or concurrent urogynecologic procedures performed including mid-urethral sling, rectocele/cystocele repairs, burch urethropexy, sacrospinous ligament fixation, uterosacral vaginal vault suspension, sacrocolpopexy
* History of multiple sclerosis
* Known malignancy of the bladder
* Bladder or ureteral injury that occurred intra-operatively
* Women who are being treated for an active urinary tract infection at the time of surgery
* Women admitted overnight who fail to go home the same day after total laparoscopic hysterectomy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No