Postoperative Urinary Retention and Urinary Track Infection (UTI) After Laparoscopic Assisted Vaginal Hysterectomy (LAVH) for Benign Disease
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Purpose
With the advent of minimally invasive surgery, laparoscopic assisted vaginal hysterectomy (LAVH) is currently advocated as an alternative to abdominal hysterectomy. Reported benefits of LAVH in short-term study, when compared with the abdominal hysterectomy, include shorter hospital stays and convalescence, less postoperative pain, lower morbidity. To our best knowledge, no study has been conducted to examine bladder catheterization is associated with PUR and UTI after LAVH. No study has been performed to evaluate the long-term sequelae of PUR after LAVH.
In this study, 150 patients undergoing LAVH are randomly assigned to have an indwelling Foley catheter for 0 (n = 50), at 7AM-8AM in the morning of postoperative day 1 (n = 50), at 7AM-8AM in the morning of postoperative day 2 (n = 50) after the procedure by selecting a sealed envelope, which is opened before the operation. The inclusion criteria are uterine fibroids, endometriosis, abnormal bleeding, uterine prolapse and intra-epithelial neoplasia of the cervix grade 3. Patients are excluded if they experienced pelvic reconstructive surgery for pelvic organ prolapse or stress urinary incontinence; if they have bacteriuria and clinical urinary tract symptoms, e.g. dysuria, frequency, urgency and stress incontinence before surgery. After surgery, all patients stay at least 2 days in the hospital. The incidences of febrile morbidity and other postoperative complications are recorded. The outcome is assessed as immediate postoperative urinary tract symptoms, urinary tract bacteriuria (defined as a positive culture > 105 organisms/µl), postoperative fever > 38°C and urinary retention or the inability to pass urine 6 hours after catheter remove. All patients are followed up at 3 months and one year after surgery. To demonstrate quality of life of women after undergo LAVH, a generic instrument of MOS Short Form 36 (SF-36) and two specific instruments for urinary problems, Incontinence Impact Questionnaire (IIQ7) and Urinary Distress Inventory (UDI) are asked to answer in all patients before surgery and postoperative follow-up. All data are analyzed by the two-tailed Fisher exact test when appropriate. Correlation coefficients are calculated to determine the associations of preoperative, intraoperative, and postoperative factors with the incidence of postoperative urinary retention and positive urine cultures. A value of p < 0.05 is considered statistically significant.
| Condition | Intervention |
|---|---|
|
Hysterectomy Urinary Retention Urinary Tract Infection |
Procedure: on Foley time |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Postoperative Urinary Retention and UTI After LAVH for Benign Disease |
- all cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | March 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A B C
A-no Foley B-remove Foley at 7AM in the morning of postoperative day 1 C-remove Foley at 7AM in the morning of postoperative day 2
|
Procedure: on Foley time
A-no Foley B-remove Foley at 7AM in the morning of postoperative day 1 C-remove Foley at 7AM in the morning of postoperative day 2
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 34 Years to 68 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Uterine fibroids
- Endometriosis
- Abnormal bleeding
- Uterine prolapse and intra-epithelial neoplasia of the cervix grade 3
Exclusion Criteria:
- If they experienced pelvic reconstructive surgery for pelvic organ prolapse or stress urinary incontinence
- If they have bacteriuria and clinical urinary tract symptoms, e.g. dysuria, frequency, urgency and stress incontinence before surgery
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Obstetrics and Gynecology, Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00564135 History of Changes |
| Other Study ID Numbers: | 96-0424C |
| Study First Received: | November 25, 2007 |
| Last Updated: | August 29, 2008 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Chang Gung Memorial Hospital:
|
hysterectomy laparoscopy urinary retention urinary tract infection catheterization |
Additional relevant MeSH terms:
|
Urinary Retention Urinary Tract Infections Urination Disorders Urologic Diseases Infection |
ClinicalTrials.gov processed this record on June 17, 2013