Ignite Creation Date:
2024-05-05 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00564135
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2007-11-25
Brief Title:
Postoperative Urinary Retention and Urinary Track Infection UTI After Laparoscopic Assisted Vaginal Hysterectomy LAVH for Benign Disease
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Postoperative Urinary Retention and UTI After LAVH for Benign Disease
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 organismsµl postoperative fever 38C 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 005 is considered statistically significant
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 eg 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 organismsµl postoperative fever 38C 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 005 is considered statistically significant
Detailed Description:
Hysterectomy is the most common major gynecological operation performed in previous study 20 of women will have undergone a hysterectomy by the age of 50 years mostly for nonmalignant conditions such as uterine fibroids endometriosis abnormal bleeding uterine prolapse and intra-epithelial neoplasia of the cervix grade 3 1 Fever is the most common perioperative complication of hysterectomy arising in about 25 2 The other early complications associated with hysterectomy including hemorrhage infection and injury to adjacent organs femoral neuropathy and thromboembolic disease 3 However whether hysterectomy is linked to the development of urinary symptoms remains controversial Some groups observed no effect or improved urinary dysfunction after hysterectomy 4-7 others reported that hysterectomy is the cause of a variety of urinary symptoms including the urethral syndrome stress incontinence detrusor overactivity and voiding difficulty 8 9 Voiding difficulty in the female is a condition in which the bladder fails to empty completely and easily after micturition Failure to detect voiding difficulties after surgery may lead to bladder overdistention and irreversible damage of the detrusor muscle 10 Postoperative urinary retention PUR is defined as the inability to void with a full bladder during the postoperative period The etiology of PUR involves a combination of many factors including sedation type of anesthesia increased sympathetic stimulation overdistension of bladder by large quantities of fluids given intravenously pain and anxiety 11 In the literature incidence of postoperative urinary retention PUR has ranged from 38 to 80 depending on the definition used and the type of surgery performed 12-15 There is no consensus on how to diagnose PUR and various criteria such as clinical symptoms bladder palpation and a fixed time interval or drainage by catheterization of more than 500 ml of urine have been used 16 Traditionally gynecologists have used an indwelling catheter for abdominal surgical procedures for several reasons including the beliefs that women would be unable to void satisfactorily in the immediate postoperative period that the indwelling catheter provided the only reliable method of assuring adequate exposure and that a catheter would be necessary in the recording of intake-output In fact prompted by womens dislike of the catheter as well as an increased incidence of postoperative urinary tract infection UTI 17 The potential sequelae of UTI include gram-negative bacteremia antimicrobial toxicity chronic bacteriuria and chronic renal disease 18 In most cases the infection is mild and easily treated but UTI is the commonest nosocomial infection and leads to increased morbidity and treatment costs 18-20 Some North American studies addressing postoperative UTI have been confounded by the use of perioperative antibiotics 17 21 suggesting UTI rates of 3-10 whereas British work has suggested a rate of 35 in control patients receiving no antibiotics 22 It has been estimated that the risk of UTI associated with indwelling catheterization is 5-10 per day of catheterization 18 and that the commonest cause of UTI in hospital is urinary catheterization 23 Short-term catheterization has been associated with subsequent bacterial colony counts of 105ml of urine in 21 of women undergoing minor surgery 24 and the incidence of positive urine cultures rises with the length of time catheterization is continued 17 18 In a randomized trial study for the effect of prophylactic antibiotics on the postoperative UTI in patients undergoing abdominal hysterectomy Ireland et al found single dose cotrimoxazole is effective in reducing the incidence of postoperative UTI from 35 in the control group to 4 in the treated group 25 Hakvoort et al studied whether prolonged urinary bladder catheterization after vaginal prolapse surgery is advantageous 26 They found that residual volumes 200 ml and need for recatheterization occurred in 9 in the 4 days catheterization group versus 40 of patients in the one day catheterization group OR 015 95 CI 0045-047 Positive urine cultures were found in 40 of cases in the 4 days catheterization group versus 4 of patients in the one day catheterization group OR 15 95 CI 32-686 By contrast in a prospective study of postoperative infection after abdominal and vaginal gynecological surgery Kingdom et al reported 40 of 115 patients receiving no prophylactic antibiotics developed a UTI in the postoperative period and this was not clearly related to the need for postoperative catheterization 25 Since prolonged indwelling urinary catheterization may be associated with an increased risk of UTI increasing patient morbidity and potentially prolonging the hospital stay 18 prophylactic antibiotics and a reduction in catheter time or no catheter after surgery might be expected to reduce this risk
Regarding the relationship of bladder catheterization with PUR in published data of prospective or retrospective studies on PUR after abdominal or vaginal hysterectomy we found that several factors of postoperative care affect the result of PUR including type of surgery use of catheter duration of catheterization and postoperative analgesia 16 17 25 27-30 During 4-year period Summitt et al have not used postoperative bladder catheter drainage after routine vaginal hysterectomy 28 To assess the potential differences in postoperative outcome they prospectively compared the use of indwelling bladder catheter drainage with no catheter use after standard vaginal hysterectomy Their data showed 2 patients in the catheterized group required recatheterization after the catheters were removed none in the no-catheter group required a catheter The results inferred that indwelling catheterization appears unnecessary after routine vaginal hysterectomy In a prospective randomized trial study Dobbs et al compared the infection rate and postoperative morbidity between indwelling catheterization and in-out catheterization at the time of abdominal hysterectomy 27 Of the 95 patients in their study 36 of that undergoing in-out catheterization had PUR requiring bladder emptying compared with 4 of those receiving an indwelling catheter In addition 29 of the catheterized group had urinary tract bacteriuria compared with 13 of the uncatheterized group They concluded that in-out urinary catheterization at the time of routine abdominal hysterectomy was associated with a significantly higher incidence of PUR compared with indwelling catheterization and may have implications for long-term bladder function 27 Dobbs et al also pointed out that abdominal muscular pain when the intra-abdominal pressure is increased during voiding coupled with the decreased sensation for voiding due to analgesia suggests that an indwelling catheter in the immediate postoperative period will help to prevent long-term morbidity from bladder atony Bodker and Lose presented the prevalence of PUR was 92 in their patients receiving gynecological surgery 16 Of 124 patients undergoing abdominal hysterectomy 137 had PUR Of 24 patients undergoing laparoscopic assisted vaginal hysterectomy LAVH 87 had PUR They concluded patients at risk of PUR are difficult to predict The risk is higher after laparotomy than after laparoscopy A retention rate of 137 after abdominal hysterectomy is fairly similar to that of 118 after gynecologic laparotomies reported by Schiotz 29 Who used an indwelling Foley catheter routinely for 20-24 hours to ascertain the risks of UTI and aymptomatic bacteriuria Based on 949 gynecologic laparotomies without the use of catheters but with bladder needling at the end of surgery Bartzen and Halferty found that 26 needed catheterization 17 They suggested that abstaining from the use of an indwelling catheter was also associated with lower cost and greater patient satisfaction
With the advent of minimally invasive surgery 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 and in some series greater cost-effectiveness 31-35 Whereas benefits of LAVH in long-term follow-up only few studies have appeared in the literature A report from Taiwan Shen et al compared 1-month and 8-year follow-up of LAVH and abdominal hysterectomy In their 8-year follow-up showed no statistically significant differences in vaginal vault prolapse cystocele rectocele enterocele postcoital bleeding and cuff granulation between LAVH and abdominal hysterectomy procedures 36 However with regard to the consequences of PUR and UTI after LAVH to our best knowledge no study has been conducted to examine bladder catheterization is associated with this problem Furthermore no study has been performed to evaluate the long-term sequelae of PUR after LAVH
Regarding the relationship of bladder catheterization with PUR in published data of prospective or retrospective studies on PUR after abdominal or vaginal hysterectomy we found that several factors of postoperative care affect the result of PUR including type of surgery use of catheter duration of catheterization and postoperative analgesia 16 17 25 27-30 During 4-year period Summitt et al have not used postoperative bladder catheter drainage after routine vaginal hysterectomy 28 To assess the potential differences in postoperative outcome they prospectively compared the use of indwelling bladder catheter drainage with no catheter use after standard vaginal hysterectomy Their data showed 2 patients in the catheterized group required recatheterization after the catheters were removed none in the no-catheter group required a catheter The results inferred that indwelling catheterization appears unnecessary after routine vaginal hysterectomy In a prospective randomized trial study Dobbs et al compared the infection rate and postoperative morbidity between indwelling catheterization and in-out catheterization at the time of abdominal hysterectomy 27 Of the 95 patients in their study 36 of that undergoing in-out catheterization had PUR requiring bladder emptying compared with 4 of those receiving an indwelling catheter In addition 29 of the catheterized group had urinary tract bacteriuria compared with 13 of the uncatheterized group They concluded that in-out urinary catheterization at the time of routine abdominal hysterectomy was associated with a significantly higher incidence of PUR compared with indwelling catheterization and may have implications for long-term bladder function 27 Dobbs et al also pointed out that abdominal muscular pain when the intra-abdominal pressure is increased during voiding coupled with the decreased sensation for voiding due to analgesia suggests that an indwelling catheter in the immediate postoperative period will help to prevent long-term morbidity from bladder atony Bodker and Lose presented the prevalence of PUR was 92 in their patients receiving gynecological surgery 16 Of 124 patients undergoing abdominal hysterectomy 137 had PUR Of 24 patients undergoing laparoscopic assisted vaginal hysterectomy LAVH 87 had PUR They concluded patients at risk of PUR are difficult to predict The risk is higher after laparotomy than after laparoscopy A retention rate of 137 after abdominal hysterectomy is fairly similar to that of 118 after gynecologic laparotomies reported by Schiotz 29 Who used an indwelling Foley catheter routinely for 20-24 hours to ascertain the risks of UTI and aymptomatic bacteriuria Based on 949 gynecologic laparotomies without the use of catheters but with bladder needling at the end of surgery Bartzen and Halferty found that 26 needed catheterization 17 They suggested that abstaining from the use of an indwelling catheter was also associated with lower cost and greater patient satisfaction
With the advent of minimally invasive surgery 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 and in some series greater cost-effectiveness 31-35 Whereas benefits of LAVH in long-term follow-up only few studies have appeared in the literature A report from Taiwan Shen et al compared 1-month and 8-year follow-up of LAVH and abdominal hysterectomy In their 8-year follow-up showed no statistically significant differences in vaginal vault prolapse cystocele rectocele enterocele postcoital bleeding and cuff granulation between LAVH and abdominal hysterectomy procedures 36 However with regard to the consequences of PUR and UTI after LAVH to our best knowledge no study has been conducted to examine bladder catheterization is associated with this problem Furthermore no study has been performed to evaluate the long-term sequelae of PUR after LAVH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None