The randomised uterine septum transsection trial (TRUST): design and protocol.

BACKGROUND: A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus. METHODS/DESIGN: A multi-centre randomised controlled trial comparing hysteroscopic septum resection and expectant management in women with recurrent miscarriage or subfertility and diagnosed with a septate uterus. The primary outcome is live birth, defined as the birth of a living foetus beyond 24 weeks of gestational age. Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage and complications following hysteroscopic septum resection. The analysis will be performed according to the intention to treat principle. Kaplan-Meier curves will be constructed, estimating the cumulative probability of conception leading to live birth rate over time. Based on retrospective studies, we anticipate an improvement of the live birth rate from 35% without surgery to 70% with surgery. To demonstrate this difference, 68 women need to be randomised. DISCUSSION: Hysteroscopic septum resection is worldwide considered as a standard procedure in women with a septate uterus. Solid evidence for this recommendation is lacking and data from randomised trials is urgently needed. TRIAL REGISTRATION: Dutch trial registry ( NTR1676 , 18th of February 2009).

Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial.

OBJECTIVE: To compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. DESIGN: Multicentre randomised controlled trial. SETTING: Eleven hospitals collaborating in a consortium for women's health research in the Netherlands. POPULATION: Women reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of ≥3 mm, measured during sonohysterography. METHODS: Women were randomly allocated to hysteroscopic niche resection or expectant management for 6 months. MAIN OUTCOME MEASURES: The primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation. RESULTS: We randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2-7 days) in the intervention group and 7 days (IQR 3-10 days) in the control group (P = 0.04); on a scale of 0-10, discomfort as a result of spotting had a median score of 2 (IQR 0-7) in the intervention group, compared with 7 (IQR 0-8) in the control group (P = 0.02). CONCLUSIONS: In women with a niche with a residual myometrium of ≥3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting-related discomfort. TWEETABLE ABSTRACT: A hysteroscopic niche resection is an effective treatment to reduce niche-related spotting.

The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.

BACKGROUND: A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. METHODS/DESIGN: We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. DISCUSSION: This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. TRIAL REGISTRATION: Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

Process evaluation of a multidisciplinary care program for patients undergoing gynaecological surgery.

PURPOSE: This study describes the process evaluation of an innovative multidisciplinary care program for patients undergoing benign gynaecologic surgery. This care program aims at improving recovery and preventing delayed return to work and consists of two steps: (1) an interactive e-health intervention for all participants, and (2) integrated clinical and occupational care management for those participants whose sick leave exceeds 10 weeks. METHODS: Eligible for this study were employed women aged between 18-65 years scheduled for a laparoscopic adnexal surgery and/or hysterectomy. Data were collected from patients, their supervisors and their gynaecologists, by means of electronic questionnaires during a 6 month follow-up period and an automatically generated, detailed weblog of the patient web portal ( www.ikherstel.nl ). Investigated process measures included: reach, dose delivered, dose received, and fidelity. In addition, attitudes towards the intervention were explored among all stakeholders. RESULTS: 215 patients enrolled in the study and accounted to a reach of 60.2 % (215/357). All intervention group patients used their account at least once and total time spent on the patient web portal was almost 2 h for each patient (median 118 min, IQR 64-173 min). Most patients visited the website several times (median 11 times, IQR 6-16). Perceived effectiveness among patients was high (74 %). In addition, gynaecologists (76 %) and employers (61 %) were satisfied with the web portal as well. Implementation of the second step of the intervention was suboptimal. Motivating patients to consent to additional guidance and developing an accurate return-to-work-prognosis were two important obstacles. CONCLUSIONS: The results of this study indicate good feasibility for implementation on a broad scale of the e-health intervention for patients undergoing benign gynaecological surgery. To enhance the implementation of the second step of the perioperative care program, adaptations in the integrated care protocol are needed.

Electrosurgical bipolar vessel sealing versus conventional clamping and suturing for vaginal hysterectomy: a randomised controlled trial.

OBJECTIVE: To compare the effects of electrical bipolar vessel sealing and conventional suturing on postoperative pain, recovery, costs and micturition symptoms in women undergoing vaginal hysterectomy. DESIGN: Randomised controlled trial. SETTING: Eight teaching hospitals in the Netherlands. POPULATION: One hundred women scheduled to undergo vaginal hysterectomy for benign conditions excluding pelvic organ prolapse. METHODS: Women were randomised to vessel sealing or conventional surgery. The quality of life related to pelvic floor function was assessed using validated questionnaires before surgery and 6 months after surgery. Pain scores and recovery were assessed using a diary, including daily visual analogue scale scores, starting from the day before surgery until 6 weeks after surgery. MAIN OUTCOME MEASURES: Visual analogue scale pain scores, surgery time, blood loss, complications, quality of life related to pelvic floor function and costs. RESULTS: The evening after surgery, women in the vessel-sealing group reported significantly less pain (5.7 versus 4.5 on a scale of 0-10, P = 0.03), but after that pain scores were similar. Operation duration was shorter for vessel sealing (60 versus 71 minutes, P = 0.05). Blood loss and hospital stay did not differ. We observed no major difference in costs between the two interventions (2903 versus 3102 €, P = 0.26). Changes in micturition and defecation symptoms were not affected by the surgical technique used. CONCLUSION: Using vessel sealing during vaginal hysterectomy resulted in less pain on the first postoperative day, shorter operating time, similar morbidity and similar pelvic floor function. No major differences in costs were found between the two interventions.

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

OBJECTIVE: To compare the effects of LigaSure versus the conventional bipolar technique on operating time and blood loss during laparoscopic hysterectomy. DESIGN: A randomised controlled trial. SETTING: Three teaching hospitals. POPULATION: Women undergoing a laparoscopic hysterectomy for benign indications. METHODS: 140 women undergoing a laparoscopic hysterectomy were randomised for LigaSure or conventional bipolar instruments. MAIN OUTCOME MEASURES: Primary outcome was operating time from initial skin incision till detachment of the uterus. Secondary outcome measures were total operating time (from initial skin incision till final skin closure), time to dissect the adnexal ligaments, intra-operative blood loss and subjective evaluation by the surgeon of the instrument used. RESULTS: No differences in operating time (from initial skin incision till uterine detachment and initial skin incision till final skin closure) using LigaSure versus conventional bipolar instruments: 97.6 versus 91.8 minutes (P = 0.39, 95% CI - 7.6 to 19.2), and 148.1 versus 142.1 minutes (P = 0.46, 95% CI - 10.1 to 22.3), respectively. The mean blood loss using LigaSure versus conventional bipolar was 234.1 versus 273.1 ml (P = 0.46, 95% CI -39.1 to 52.7). Various subjective efficacy and instrument handling parameters were significantly different between the two instruments and between the different participating centres. CONCLUSIONS There were no significant differences in operating time and blood loss between the use of LigaSure and the use of conventional bipolar instruments during laparoscopic hysterectomy, even after correction for potential confounders. User satisfaction parameters were assessed as significantly different by surgeons of the participating centres.

Reproducibility of saline contrast sonohysterography for the detection of intracavitary abnormalities in women with abnormal uterine bleeding.

OBJECTIVES: Saline contrast sonohysterography (SCSH) is a diagnostic test for the examination of intracavitary abnormalities. The objective of this study was to calculate interobserver and intraobserver agreement for the interpretation of video recordings of SCSH procedures according to different levels of experience. METHODS: SCSH examinations were carried out by an operator experienced at performing SCSH and were recorded on video. To assess interobserver and intraobserver agreement, video material was scored by observers allocated to different groups according to their level of experience. Observers who had performed 25 or more SCSH procedures were defined as experienced (Group A), those who had carried out 1-24 as less experienced (Group B), and those with no experience of performing SCSH as inexperienced (Group C). All observers were blinded to the case histories of the patients. RESULTS: There was a significant difference in kappa values for interobserver agreement between the most experienced group and the less experienced observers. Group A, with the highest level of experience, had a mean kappa value of 0.62 (95% CI, 0.56-0.67), compared with 0.38 (95% CI, 0.33-0.43) in Group B and 0.47 (95% CI, 0.43-0.52) in Group C. The interobserver agreement in Group A was significantly higher than that in Groups B and C (P < 0.001 and P = 0.023, respectively), and Group C performed better than Group B (P = 0.024). Intraobserver agreement (n = 7) was good, with a mean kappa value of 0.66 (Group A, 0.63; Group C, 0.71). CONCLUSIONS: Interobserver agreement in interpretation of video recordings of SCSH by inexperienced sonographers is poor, whereas the intraobserver agreement is good. We consider the poor interobserver agreement to be due to non-uniform diagnostic criteria. Uniform diagnostic criteria for SCSH should be incorporated into the training of residents and other physicians performing these examinations.

Ultrasound observations of a malignant cervical teratoma of the fetus in a case of polyhydramnios: case history and review.

A case report is given concerning an extremely rare case of malignant teratoma of the neck with mature and immature metastatic lesions in the lungs in an immature fetus. The ultrasound observations are reported. The differential diagnosis of masses in the fetal neck, as can be observed by ultrasound, is discussed, with a review of the literature on this subject.