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Postoperative Urinary Retention and Urinary Track Infection (UTI) After Laparoscopic Assisted Vaginal Hysterectomy (LAVH) for Benign Disease

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00564135
First received: November 25, 2007
Last updated: August 29, 2008
Last verified: August 2008
  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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564135

Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ching-Chung Liang, MA CGMH
  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:
Communicable Diseases
Infection
Urinary Retention
Urinary Tract Infections
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014