Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

AIMS: To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. METHODS: A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). RESULTS: Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. CONCLUSIONS: At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare.

Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial.

BACKGROUND: We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women. STUDY DESIGN: The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O. RESULTS: A total of 480 patients (85%) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87% of patients after TVT and in 84% after TVT-O; 64% and 59% of patients, respectively, reported no pad use, and 88% of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings' Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications. CONCLUSIONS: Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).

Reoperation for pelvic organ prolapse within 10 years of primary surgery for prolapse.

INTRODUCTION AND HYPOTHESIS: A presumed high failure rate of conventional procedures for prolapse has been part of the rationale for new surgical approaches. The aim of the present retrospective cohort study was to estimate the reoperation rate for prolapse within 10 years of primary surgery for prolapse. METHODS: We identified all patients who underwent primary surgery for prolapse at four large regional centers in Austria in 1997 and 1998. Hospital databases were searched to determine whether patients had been reoperated for prolapse through 2008. RESULTS: A total of 456 patients underwent a primary operation for prolapse in 1997 and 1998. The most common primary operation was vaginal hysterectomy with colporrhaphy (89 %). We identified 13 reoperations for prolapse, for a 10-year reoperation rate of (at least) 2.9 %. The median interval between primary and secondary surgery was 5.5 years (range 1.5-10 years). CONCLUSION: The reoperation rate for prolapse after primary vaginal hysterectomy and colporrhaphy appears to be modest in this series of patients.

Transobturator tapes for stress urinary incontinence: Results of the Austrian registry.

OBJECTIVE: We established a voluntary registry to collect data on the perioperative course of transobturator tape operations for stress incontinence. STUDY DESIGN: Forty-seven centers completed a 1-page, 15-item questionnaire per procedure. RESULTS: Data on a total of 2543 operations with 11 different tape systems were collected. Intraoperative complications were noted for 120 procedures (4.7%). These included 85 cases of increased bleeding (3.3%), 10 vaginal perforations (0.4%), 10 bladder perforations (0.4%), and 2 urethral perforations. Reoperations attributable to the tape procedure were reported for 57 patients (24 tapes cut or loosened for voiding dysfunction, 11 vaginal erosions, 7 abscesses with erosions). One patient was reoperated at 14 days for a retropubic hematoma. There were no reports of bowel or major vessel injuries or mortality. Significant postoperative pain was reported for 12 patients (0.5%), although this was not specifically asked for in the questionnaire. CONCLUSION: Significant complications with transobturator tapes are uncommon. Bladder perforations occurred more frequently with outside-in than with inside-out techniques. Vaginal erosions, abscesses, and pain may be more common with transobturator than with retropubic tapes, and this may be due to the structure of the tapes rather than to the route of passage.

Bleeding complications with the tension-free vaginal tape operation.

OBJECTIVE: This study was undertaken to analyze bleeding problems with tension-free vaginal tape (TVT) operations in a national registry. STUDY DESIGN: We studied patients for whom increased intraoperative bleeding or reoperation for bleeding/hematoma with TVT operation were reported to the registry. RESULTS: Bleeding problems were reported for 151 of 5578 (2.7%) TVT operations. Increased intraoperative bleeding was reported for 106 (1.9%) and reoperation (or conversion) in 45 (0.8%) patients (both in 5 patients). Increased intraoperative bleeding was managed conservatively in 103 patients (95%). Overall, 45 (0.8%) patients required reintervention for bleeding or hematoma. The reinterventions comprised 34 laparotomies, 4 transvaginal evacuations of hematomas, 3 revisions for bleeding from a suprapubic catheter site, and 2 revisions of the vaginal incision (details unclear in 1 patient). Bleeding was considered arterial in 12% (including 1 external iliac artery injury and 1 obturator artery injury) and venous or unknown in 88%. Of reoperated patients, 39% were reoperated within 24 hours, 20% within 2 to 10 days, and 41% within 11 to 56 days after TVT placement. Overall, 19 patients received blood transfusions (range, 1-10 units). There were no deaths from bleeding complications. CONCLUSION: Bleeding complications were reported with less than 3% of 5578 TVT operations. Most cases of increased intraoperative bleeding were managed conservatively; 0.8% of patients required conversion or reoperation.

Implementation of sentinel lymph node biopsy with blue dye outside a specialized center: can we improve quality assurance?

Implementation of sentinel lymph node biopsy (SLNB) outside a specialized center requires adequate quality control and quality assurance for optimal patient care. We examine the model of a supervising breast cancer unit in improving quality assurance in the treatment of breast cancer patients. A total of 76 SLNBs followed by level I/II axillary dissection were performed in the general hospital by using patent blue V alone. Patient selection, technical information, documentation, pathologic examination of the sentinel lymph node (SLN), and surgical training were provided by the supervising breast cancer unit. In 73 of 76 SLNBs, identification of the sentinel node was successful. The false-negative rate was 2.7% and the accuracy was 98.6%. The results of the procedure in the general hospital were comparable with the results of the supervising breast cancer unit. The model of a supervising breast cancer unit seems to accelerate surgeons' learning curve and may provide support for appropriate application of the SLNB in a wider number of nonspecialized centers.

Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy.

OBJECTIVE: We analyzed the use of an electrosurgical bipolar vessel sealing system for radical abdominal hysterectomy. METHODS: We compared operating time, transfusion requirements and other surgical parameters in 52 patients undergoing radical abdominal hysterectomy with systematic pelvic +/- paraaortic lymphadenectomy for stage IB1-IIB cervical cancer between January 2001 and June 2004. At 21 operations between January 2001 and March 2002, the parametrium, paracolpos and vaginal cuff were resected with clamps and the pedicles suture ligated; 31 operations between November 2001 and June 2004 were done with a bipolar vessel sealing system (LigaSure Vessel Sealing System, Valleylab, Boulder, CO). Four surgeons did all operations. Data were compared with the t test. RESULTS: Patients operated with the LigaSure system received fewer packed RBC transfusions than those operated with clamps (mean, 0.61 +/- 1.1 vs. 2.14 +/- 2.6 units, respectively; P = 0.01), even when looking at patients who underwent only pelvic (without paraaortic) lymphadenectomy (mean, 0.52 +/- 1.1 vs. 1.29 +/- 1.2 units, respectively; P = 0.02). The transfusion rate in the two groups was 26% (8/31) and 67% (14/21), respectively (P < 0.05). Operating time did not differ significantly (199 +/- 33 vs. 213 +/- 45 min, respectively). There were no significant differences between the groups in number of pelvic nodes removed, febrile morbidity, postoperative stay, or days until residual urine <100 ml. One patient in the LigaSure group developed a ureterovaginal fistula that resolved with stenting. CONCLUSION: The LigaSure system appears useful to reduce blood loss at radical abdominal hysterectomy.