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Completed

NCT Number: NCT02742636

When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy?

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).

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Key information

Conditions

Urinary Tract Infection Bladder Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Retention Urinary Tract Infections Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center, Leiden, North Holland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

foley catheter

Device

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.

Primary outcomes

  1. Urinary retention (inability to void)

    Time frame: 6 hours after removal of urinary catheter

Secondary outcomes

  1. Rate of re-catheterisation

    Time frame: 6 hours without voiding

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

    Time frame: 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)

  3. Patient satisfaction (self-administrated questionnaire)

    Time frame: 6 hours postoperative; 24 hours and 6 weeks

  4. Visual analogue scale score (VAS score)

    Time frame: 6 hours postoperative; 24 hours

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Alrijne Hospital
  • Bronovo Hospital
  • Groene Hart Ziekenhuis
  • Haga Hospital
  • Medical Center Haaglanden
  • Reinier de Graaf Groep

Registry information

Official study title

When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.

Acronym: MUCH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2016
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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