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| Name | Class |
|---|---|
| Bronovo Hospital | OTHER |
| Haga Hospital | OTHER |
| Alrijne Hospital | OTHER |
| Reinier de Graaf Groep |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (treatment group) | Experimental | The patients in this group will have their catheter directly removed in the OR after LH. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary retention (inability to void) | 6 hours after removal of urinary catheter |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | North Holland | 2311 AZ | Netherlands | ||
| Reinier de Graaf Groep |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34184246 | Derived | 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. |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
| Groene Hart Ziekenhuis | OTHER |
| Medical Center Haaglanden | OTHER |
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| Patient satisfaction (self-administrated questionnaire) | 6 hours postoperative; 24 hours and 6 weeks |
| Visual analogue scale score (VAS score) | 6 hours postoperative; 24 hours |
| Delft |
| Netherlands |
| Groene Hart Ziekenhuis | Gouda | Netherlands |
| Alrijne Hospital | Leiden | Netherlands |
| Bronovo Hospital | The Hague | Netherlands |
| Haga Hospital | The Hague | Netherlands |
| Medisch Centrum Haaglanden | The Hague | Netherlands |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |