To compare the 1-year (previously published) and 3-year objective and subjective cure rates, and complications, related to the use of a collagen-coated transvaginal mesh for anterior vaginal wall prolapse against a conventional anterior repair.
Randomised controlled study.
Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.
A total of 138 women, of 55 years of age or older, admitted for stage =2 anterior vaginal wall prolapse.
The women scheduled for primary anterior vaginal wall prolapse surgery were randomised between conventional anterior colporrhaphy and surgery with a collagen-coated prolene mesh. All patients were evaluated using the Pelvic Organ Prolapse Quantification (POP-Q) assessment before and after surgery. Symptoms related to pelvic organ prolapse were evaluated using the Pelvic Floor Impact Questionnaire (PFIQ-7) and the Pelvic Floor Distress Inventory (PFDI-20).
To identify risk factors in recurrence and to evaluate anatomic and functional results of vaginal sacrospinous ligament fixation and pelvic floor reconstruction for genital prolapse.
One hundred and thirty-eight women underwent surgery for uterovaginal or vault prolapse. Follow-up data were available for 122 cases; 83% were examined and others were interviewed by telephone. The median (range) follow-up was 24 (1-141) months. Cox regression was used to identify risk factors associated with recurrence; uni- and multivariate regression was used to identify risk factors underlying postoperative infections because infections were found to be a risk factor of recurrence. Recurrence-free survival was estimated using the Kaplan-Meier method.
Seven (5%) patients suffered severe cardiopulmonary complications including one postoperative death due to a pulmonary embolism. Twenty-six (21%) patients suffered a recurrence, 14 with cystocele. Ten patients with recurrence were symptomatic and six underwent a re-operation. The Cox regression model showed that vaginal cuff infection raised the odds ratio (OR) for recurrence to 6.13 [confidence interval (CI) 1.80-20.83] and urinary tract infection to 3.65 (CI 1.40-9.47). In both uni- and multivariate analysis, lack of intravenous antibiotic prophylaxis, age less than 73 years and vaginal ulcerations were statistically significant risk factors for postoperative infection. Eleven (33%) out of 33 sexually active women reported improvement and three (9%) complained of dyspareunia.
Transvaginal sacrospinous ligament fixation with pelvic floor repair is an effective means of correcting both vault prolapse and uterine procidentia. Women who wish to preserve coital function will also benefit from this operation. Postoperative infection is an independent and most important individual risk factor underlying recurrence. Prophylactic antibiotics seem to be effective in reducing the rate of postoperative infections.
To investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy.
A randomised controlled study.
Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.
Women aged 55 years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage 2 or higher.
Women scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms, and sexual function were evaluated using the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire.
The primary outcome was objective cure, defined as prolapse below POP-Q stage 2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications.
In total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.9 ± 6.4 years versus 64.7 ± 6.6 years, respectively; mean ± SD). The objective cure rate was 39.8% (95% CI 28.6-50.9%) in the anterior colporrhaphy group, compared with 88.1% (95% CI 80.7-95.6%) in the mesh group (P
To determine a syndrome score threshold on PFDI or PFIQ predictive of a significant improvement in post-operative functional results.
A retrospective case review (Canadian Task Force Classification II-2).
University and research hospital.
Women diagnosed with pelvic organ prolapse and repaired with synthetic vaginal mesh.
Quality of life was arbitrarily considered to have improved significantly if the score decreases by more than 50% between pre-operatively and 36 months post-operatively. We investigated the pre-operative cut-off score predictive of no quality of life improvement at M36 from a prospective trial for surgical pelvic organ prolapse treatment.
The most accurate pre-operative cut-off score predicting a failure to improve quality of life at 36 months post-operatively was 62/300 (PFDI Score). This cut-off value had a positive predictive value of 83.6% and specificity of 62.1%. No significant threshold was obtained from the PFIQ score.
The intensity of symptoms before surgery may interfere as a predictive factor for outcome.
The aim of this study was to compare laparoscopic colposuspension with tension-free vaginal tape (TVT) in terms of costs to the county.
In a prospective, randomized study, we approached 270 consecutive women presenting for evaluation of stress urinary incontinence symptoms at one university hospital. Preoperatively, and at 1-year follow-up, the women underwent urodynamic evaluation, an ultra-short pad-test and completed a lower urinary tract symptoms questionnaire. We randomized 79 consenting, eligible women to either procedure; a 1-year follow-up examination was performed on 68/71 (96%) women that were available. The procedures were performed as described previously. Main outcome measures were all relevant costs for goods and services associated with the procedures.
The baseline characteristics of the two groups were similar. The TVT procedure was performed significantly faster than the laparoscopic colposuspension, i.e. 44.9 +/- 14.2 min compared with 60.5 +/- 13.4 min (p
Evaluation of cost-effectiveness of new surgical techniques is important. As the data on incontinence procedures are scarce, we evaluated the cost-effectiveness of tension-free vaginal tape procedure and laparoscopic mesh colposuspension as a primary surgical treatment for female stress urinary incontinence.
In four university teaching hospitals and two central hospitals 128 stress incontinent women were randomized to tension-free vaginal tape procedure (n=70) or laparoscopic mesh colposuspension (n=51) in order to investigate the clinical performance of these two procedures. Primary objective clinical outcome measures were: stress test and 48-h pad test. Secondary subjective outcome measures were health-related quality of life measured in terms of visual analogue scale and Urinary Incontinence Severity Score. Alongside the clinical trial, a cost-effectiveness analysis for the main outcome measures was performed.
The changes in the 48-h pad test result did not reach statistical significance (p=0.105). When the visual analogue scale or Urinary Incontinence Severity Score are used as the outcome measure, the tension-free vaginal tape is more cost-effective than laparoscopic mesh colposuspension over a follow-up period of one year (p
BACKGROUND: The study's objective was to compare the cost of vaginal wall repair under local anesthesia, undertaken in either an inpatient or an outpatient regimen. The perspective used was that of a department of gynecology over the short and medium term. METHODS: The analysis was based on 2 consecutive cohorts of inpatients and outpatients treated in a Danish university hospital. Data on resource use were collected from clinical records and via a patient telephone survey. Salary and drug costs were estimated from national sources. Costs for consumables, complications and overnight stays were estimated from local data. The analysis compared the costs of inpatient and outpatient surgery relating to staff time, anesthesia, operation, recovery, overnight stays and complications. Multiple regression was employed to adjust for confounding variables. RESULTS: The average cost was estimated to be 10,400 DKK per inpatient and 6,100 DKK per outpatient (2004 price level: 1 euro = 7.50 DKK). Costs relating to overnight stays and staff costs during operation were the largest contributors to the cost difference. Total cost was significantly associated with type of regimen (in- or outpatient), type of operation and complications. After adjustment for confounding variables, the cost difference was estimated at 3,700 DKK (95% bootstrap confidence interval: 2,500-5,000 DKK). The risk of complication was similar for the 2 regimens. CONCLUSION: Vaginal wall repair under local anesthesia, undertaken in an outpatient regimen, appears to be less costly than in an inpatient regimen.
To evaluate the outcome of total laparoscopic hysterectomy with and without the use of barbed suture.
We conducted a retrospective study among patients who underwent total laparoscopic hysterectomy between February 2008 and August 2012. The parameters evaluated were age, BMI, operative time, hospital stay, pre- and postoperative hemoglobin levels, uterine weight, intraoperative blood loss, and postoperative complications.
A total of 202 women underwent total laparoscopic hysterectomy; barbed suture (V-Loc) was used in 63 women, and polydioxanone (PDS) in 139. Estimated blood loss, difference in hemoglobin level before and after surgery, operative time, and the duration of hospital stay were comparable between the two groups of patients. The incidence of postoperative fever was higher in the V-Loc group than in the PDS group (P = 0.003). Multiple linear regression analysis showed that the incidence of postoperative fever was related to BMI (P = 0.02, r = 0.22) and estimated blood loss (P = 0.004, r = 0.28) and not to age, operative time, or uterine weight.
The use of barbed suture to close the vaginal vault after laparoscopic hysterectomy, compared with standard suture, results in similar operative time, blood loss, and duration of hospital stay. The use of barbed suture is technically less demanding than the use of regular sutures.
OBJECTIVE: Our aim was to describe the need for postoperative hospitalization after vaginal surgery for utero-vaginal prolapse with well-defined charts for postoperative care. DESIGN: A prospective, descriptive study. Consecutive women admitted for first-time vaginal surgery for utero-vaginal prolapse at a public university hospital in Copenhagen, Denmark, underwent surgery and postoperative care in a fast track setting from September 15, 1999 to June 15 2000. METHODS: A multimodal rehabilitation model with emphasis on information, standardized general anesthesia, reduced surgical distress, optimized pain-relief, early oral nutrition and ambulation, minimal use of indwelling catheter and vaginal packing. OUTCOME MEASURES: Postoperative hospital stay, complications, re-admission, success rate, patients' satisfaction and acceptability. RESULTS: Forty-one women with a median age of 69 years (range, 44-88 years) were included. All underwent anterior and/or posterior vaginal repair. Nineteen (46.3%) underwent vaginal hysterectomy, and eight (19.5%) underwent the Manchester procedure. Postoperative hospital stay was median 24 hr. Only three (7.3%) were discharged later than 48 hr. No re-admissions occurred. The most frequent complications were urinary retention exceeding 450 ml, and urinary tract infection (12.2%, and 9.8%, respectively). Short-term success rate was 97.6%. Patients' satisfaction rates were 85.4-95.1%. The median score of acceptability was 10 on a 0-10 points scale. CONCLUSION: The need for postoperative hospitalization was median 24 hr after vaginal surgery in a fast track setting, independently of the complexity of the procedure performed. Short-term success rate, satisfaction rates, and acceptability were all excellent. Follow up has been established to evaluate long-term success rates and recurrence.