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When is the best moment to remove the urinary catheter after laparoscopic hysterectomy? A multicentre randomized controlled trial comparing direct versus delayed removal

When is the best moment to remove the urinary catheter after laparoscopic hysterectomy? A multicentre randomized controlled trial comparing direct versus delayed removal - MUCH-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43898
Enrollment
160
Registered
2016-04-06
Start date
2016-05-31
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinewegen (urineretentie en urineweginfectie) Urinary retention

Interventions

Treatment group: the patients in this group will have their catheter directly removed in the OR after LH. Control group: the patients in the control group will have their catheter removed one day a

Sponsors

Gynaecologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Older than 18 years - Laparoscopic hysterectomy (with or without salpingo-oophorectomie)

Exclusion criteria

Exclusion criteria: - Younger than 18 years old - Concomitant procedures such as prolapse surgery, severe endometriose 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

Design outcomes

Primary

MeasureTime frame
Urinary retention, defined as the inability to void (completely) 6 hours after catheter removal.

Secondary

MeasureTime frame
Rate of re-catheterization Urinary tract infection, based on clinical symptoms and urine sample after catheter removal Length of hospital stay Moment of ambulation (defined as first time out of bed) Presence of urine (objectified with bladder scan) after voiding before discharge Patient*s perspectives Financial outcomes (cost-effectiveness)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)