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

NCT00564135 | Completed

• 1 other identifier: 96-0424C
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hysterectomy; Urinary Retention; Urinary Tract Infection

Keywords

hysterectomy; laparoscopy; urinary retention; urinary tract infection; catheterization

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  one year

Study Arms (1)

A B C

EXPERIMENTAL

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

Interventions

on Foley time PROCEDURE

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

A B C

Eligibility Criteria

• Age: 34 Years - 68 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uterine fibroids
• Endometriosis
• Abnormal bleeding
• Uterine prolapse and intra-epithelial neoplasia of the cervix grade 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (1)

• 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.

  PMID: 34184246 DERIVED

MeSH Terms

Conditions

Urinary Retention; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Officials

• Ching-Chung Liang, MA

  CGMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2007
• First Posted: November 27, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 3, 2015

Record last verified: 2008-08