NCT03126162

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 8, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

April 14, 2017

Last Update Submit

June 2, 2018

Conditions

Laparoscopic HysterectomyEnhanced Recovery After Surgery

Keywords

minimally invasive gynecologic surgerysame-day dischargebladder testing

Outcome Measures

Primary Outcomes (1)

  • Time to first spontaneous void

    Our primary hypothesis is that patients who undergo same-day total laparoscopic hysterectomy that are randomized into the group who have their bladders backfilled with 200 cc normal saline post-operatively, prior to removal of the foley catheter will have a shorter time to first spontaneous void.

    From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Secondary Outcomes (1)

  • Time to discharge from the hospital after same-day laparoscopic hysterectomy

    From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Other Outcomes (1)

  • Post-operative urinary retention rates

    From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Study Arms (2)

Bladder Backfilled group

EXPERIMENTAL

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

Procedure: InstilIing normal saline into bladderProcedure: Removal of foley catheter

Control group

PLACEBO COMPARATOR

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.

Procedure: Removal of foley catheter

Interventions

InstilIing normal saline into bladderPROCEDURE

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.

Bladder Backfilled group
Removal of foley catheterPROCEDURE

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

Bladder Backfilled groupControl group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHysterectomies are only performed on women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital, UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.

    PMID: 27521884RESULT

  • Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, Tiouririne M, Hedrick TL. Enhanced Recovery Implementation in Major Gynecologic Surgeries: Effect of Care Standardization. Obstet Gynecol. 2016 Sep;128(3):457-66. doi: 10.1097/AOG.0000000000001555.

    PMID: 27500337RESULT

  • Kalogera E, Bakkum-Gamez JN, Jankowski CJ, Trabuco E, Lovely JK, Dhanorker S, Grubbs PL, Weaver AL, Haas LR, Borah BJ, Bursiek AA, Walsh MT, Cliby WA, Dowdy SC. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-328. doi: 10.1097/AOG.0b013e31829aa780.

    PMID: 23969801RESULT

  • Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.

    PMID: 18060956RESULT

  • 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.

    PMID: 30969209DERIVED

Study Officials

  • Suketu Mansuria, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 24, 2017

Study Start

June 8, 2017

Primary Completion

May 4, 2018

Study Completion

May 4, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

US(1)