NCT02742636

Brief Summary

Objective: The aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. In addition, we want to investigate patient's experience on this subject. Study design: Randomized Controlled trial, non-inferiority study. Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy. Intervention:

  • Group A (treatment group): the patients in this group will have their catheter directly removed in the OR after LH.
  • Group B (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

7 active sites

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 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

April 1, 2016

Last Update Submit

August 22, 2017

Conditions

Urinary Tract InfectionBladder Retention

Outcome Measures

Primary Outcomes (1)

  • Urinary retention (inability to void)

    6 hours after removal of urinary catheter

Secondary Outcomes (4)

  • Rate of re-catheterisation

    6 hours without voiding

  • Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)

    Dipstick: first urine after removal of catheter (group 1: direct after OR, group 2: at least 6 hours after OR), clinical symptoms through study period (up to 6 weeks postoperative)

  • Patient satisfaction (self-administrated questionnaire)

    6 hours postoperative; 24 hours and 6 weeks

  • Visual analogue scale score (VAS score)

    6 hours postoperative; 24 hours

Study Arms (2)

Group A (treatment group)

EXPERIMENTAL

The patients in this group will have their catheter directly removed in the OR after LH.

Device: Foley catheter

Group B (control group)

ACTIVE COMPARATOR

The patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).

Device: Foley catheter

Interventions

Foley catheterDEVICE

The aim of this study is to evaluate if direct removal of the urine catheter after an LH (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery.

Group A (treatment group)Group B (control group)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years
  • Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomy)

You may not qualify if:

  • Concomitant procedures such as prolapse surgery, severe endometrioses and/or bowel resection
  • Preoperative known urinary voiding problems (incontinence)
  • Preoperative known urinary tract infection
  • Patients suffering from diseases potentially associated with inability to void (e.g. MS)
  • A Gravid or postpartum hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Leiden University Medical Center

Leiden, North Holland, 2311 AZ, Netherlands

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Alrijne Hospital

Leiden, Netherlands

Location

Bronovo Hospital

The Hague, Netherlands

Location

Haga Hospital

The Hague, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, Netherlands

Location

Related Publications (1)

  • Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

    PMID: 34184246DERIVED

MeSH Terms

Conditions

Urinary Tract InfectionsUrinary Retention

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 19, 2016

Study Start

May 31, 2016

Primary Completion

June 21, 2017

Study Completion

June 21, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(7)