Marlies Y. Bongers

Randomised controlled trial of bipolar radio-frequency endometrial ablation and balloon endometrial ablation.

Objective  To compare the effectiveness of two second‐generation ablation techniques, bipolar radio‐frequency impedance‐controlled endometrial ablation (NovaSure) and balloon ablation (ThermaChoice), in the treatment of menorrhagia.

Five‐year follow up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation

Objective  We have previously reported that NovaSure® was more effective than balloon ablation at 12 months follow up in the treatment of menorrhagia. In this paper, we report the 5‐year outcome of this study. The objective was to evaluate amenorrhoea rates, hysterectomy rate, and quality of life associated with the bipolar impedance‐controlled endometrial ablation technique (NovaSure) in comparison with balloon ablation technique (ThermaChoice®) at 5 years after administration.

Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial.

OBJECTIVE: To report the 4-year follow-up quality-of-life data of a randomized controlled trial between abdominal and laparoscopic hysterectomy and to investigate whether any difference in quality of life would remain long-term. METHODS: Patients scheduled for hysterectomy for benign indications were randomized and received the Dutch version of the Short Form 36 questionnaire. The Short Form 36 consists of eight domains in which 100 points can be obtained. Higher scores denote a higher quality of life. A linear mixed model was used to study the differences between the two groups up to 4 years after surgery for each of the domains and the total Short Form 36 score separately. RESULTS: Fifty-nine patients were randomized (27 to laparoscopic hysterectomy and 32 to abdominal hysterectomy). Median follow-up after surgery was 243 weeks (range, 188–303 weeks). The overall response rate on the Short Form 36 questionnaire after 4 years was 83% (49 of 59 patients). Total Short Form 36 questionnaire scores were significantly higher in patients after laparoscopic compared with abdominal hysterectomy up to 4 years after surgery (overall mean difference 50.4 points [95% confidence interval 1.0–99.7] in favor of laparoscopic hysterectomy). Higher scores were also found on the domains physical role functioning, social role functioning, and vitality. CONCLUSION: With a follow-up of 4 years, patients who underwent laparoscopic hysterectomy reported a better quality of life compared with abdominal hysterectomy. Therefore, patients in whom vaginal hysterectomy is not possible should be able to have a laparoscopic hysterectomy, if feasible, in terms of uterine size. CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN15214439. LEVEL OF EVIDENCE: I

Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial†‡§

To assess in women with stress urinary incontinence (SUI) the value of urodynamics prior to treatment.

Tubal perforation by Essure: three different clinical presentations

OBJECTIVE To assess the convenience and safety of Essure sterilization in an outpatient setting and the use of ultrasound as diagnostic tool for verification of proper placement for the 3-month follow-up. DESIGN Prospective cohort study. SETTING Teaching hospital department of obstetrics and gynecology. PATIENT(S) Female patients with a request for permanent tubal sterilization. INTERVENTION(S) Essure sterilization. MAIN OUTCOME MEASURE(S) Bilateral tubal occlusion after Essure sterilization and complication rate. RESULT(S) A total of 149 patients were scheduled for Essure sterilization. Microinsert placement was attempted in 143 patients. Bilateral placement of the device was successful in 95% (95% confidence interval [CI] 92%-99%). Seven attempts were unsuccessful. The complication rate was 2% (n = 3), and all involved a perforation. These three cases are discussed in detail. Vaginal ultrasound was conclusive in 91.7% (95% CI 87%-96%); two perforations were not recognized on the ultrasound. CONCLUSION(S) Essure sterilization is a safe and reliable sterilization method in an outpatient setting. Perforation of the device is the most frequent complication. Vaginal ultrasound is reliable for verification after an uncomplicated procedure. When the procedure is difficult (e.g., higher resistance, more pain then average, more time or more than two devices needed), a hysterosalpingogram should be performed.

Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered.

BackgroundStress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting.The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered.Methods/designA multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI.Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration.Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation.Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information.Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires.Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized.The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes.Trial registrationClinical Trials NCT00814749.

Perioperative outcomes using LigaSure compared with conventional bipolar instruments in laparoscopic hysterectomy: a randomised controlled trial

Please cite this paper as: Janssen P, Brölmann H, van Kesteren P, Bongers M, Thurkow A, Heymans M, Huirne J. Perioperative outcomes using LigaSure compared with conventional bipolar instruments in laparoscopic hysterectomy: a randomised controlled trial. BJOG 2011;118:1568–1575.

Clinimetric properties of 3 instruments measuring postoperative recovery in a gynecologic surgical population.

BACKGROUND General, health-related quality-of-life questionnaires and recovery-specific questionnaires have been used to measure recovery in surgical patients. The aim of this study was to evaluate the clinimetric properties of 3 recovery instruments and to examine whether recovery-specific instruments are useful. METHODS The Quality of Recovery-40 (QoR-40), Recovery Index-10 (RI-10), and RAND-36 health survey were used to measure recovery in women undergoing different types of hysterectomy in the first 12 weeks after operation. Construct validity was assessed by testing predefined hypotheses. The changes observed during the postoperative period were used as indicators for responsiveness. RESULTS One hundred and sixty-one women were included. Response rate and internal consistency were found satisfactory. The highest number of hypotheses used for assessment of construct validity was confirmed in the RI-10. The RI-10 was more responsive compared with the QoR-40 and the RAND-36. CONCLUSIONS Because construct validity and responsiveness were greatest in the RI-10, we conclude that this short recovery-specific instrument is useful in studies evaluating postoperative recovery. We recommend the use of the RI-10, unless the immediate postoperative days are of interest in which the QoR-40 was valid.

Parasitic myoma after laparoscopic morcellation: a systematic review of the literature

Laparoscopic morcellation is frequently used for tissue removal after laparoscopic hysterectomy or myomectomy and may result in parasitic myomas, due to seeding of remained tissue fragments in the abdominal cavity. However, little is known about the incidence and risk factors of this phenomenon.

Nerve injury: an exceptional cause of pain after TVT

Persistent pain after a tension-free vaginal tape procedure is rare. Perforation or erosion of the tape into the bladder, urethra, or vagina; hematoma formation; and tape rejection are the most common causes. Less frequent causes are injury to the pelvic bone or to iliopectineal ligaments. In this case report, we present the passage of the tape through a nerve structure as the source of persistent and severe retropubic pain. Diagnostic procedures, such as cystoscopy, ultrasound, and MRI scanning, showed no abnormal findings. Treatment was initially conservative, but only locally injected analgesics and corticosteroids relieved the pain temporarily. Finally, surgical exploration revealed the inadvertent course of the tape through branches of the ilioinguinal/iliohypogastric nerve, which only became clear after pathological examination of the excised tape.