Transrectal high-intensity focused ultrasound (HIFU) for management of rectosigmoid deep infiltrating endometriosis: results of Phase-I clinical trial.

OBJECTIVES: Deep infiltrating endometriosis (DIE) of the rectosigmoid is associated with painful symptoms. When medical treatment is ineffective, surgical resection remains the standard treatment, despite significant risk of adverse events. High-intensity focused ultrasound (HIFU) is a minimally invasive ablative procedure. Focal One® is a transrectal HIFU (TR-HIFU) device used in prostate cancer treatment. The primary objective of this study was to confirm the feasibility of treatment with TR-HIFU in patients presenting with posterior DIE with rectosigmoid involvement. We also assessed its safety and clinical efficacy in this context. METHODS: This was a non-controlled, prospective, Phase-I clinical trial in a French University Hospital which is a multidisciplinary center for management of endometriosis. Included were patients older than 25 years, without plans to conceive within 6 months, who presented with a single lesion of posterior DIE, with rectosigmoid invasion, after failure of hormonal therapy. All lesions were assessed preoperatively using transvaginal sonography and magnetic resonance imaging. Patients completed questionnaires on gynecological and intestinal symptoms (similar to a visual analog scale (VAS)), and on quality of life (Medical Outcomes Study 36-item short-form survey (SF-36) and, for the second half of patients recruited, symptom scoring system for constipation (KESS), female sexual function index (FSFI) and endometriosis health profile short-version score (EHP-5)), before, and at 1, 3 and 6 months after, TR-HIFU treatment with a Focal One real-time ultrasound-guided HIFU device. RESULTS: Twenty-three consecutive patients were included in the study between September 2015 and October 2019. All 23 lesions were visualized, giving a detection rate of 100%. Twenty lesions were treated ('feasibility rate', 87.0%): in 13 the whole lesion was treated and in seven the lesion was treated partially. The mean duration of the TR-HIFU procedure was 55.6 min. We observed a significant improvement in VAS score at 6 months, with differences relative to preoperative scores as follows, for: dysmenorrhea (-3.6, P = 0.004), dyspareunia (-2.4, P = 0.006), diarrhea (-3.0, P = 0.006), constipation (-3.0, P = 0.002), dyschezia (-3.2, P = 0.003), false urge to defecate (-3.3, P = 0.007), posterior pelvic pain (-3.8, P = 0.002) and asthenia (-3.8, P = 0.002). There was also a significant improvement in the SF-36 score, with an increase at 6 months relative to the preoperative score in both the physical component summary (+ 9.3%, P = 0.002) and mental component summary (+ 10.9%, P = 0.017). No major complications occurred during or after any procedure. CONCLUSIONS: TR-HIFU therapy for posterior DIE is feasible. If its efficacy and safety are confirmed, it could be a minimally invasive alternative to surgery for the treatment of rectosigmoid endometriosis. © 2019 Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Evaluation of an e-learning program for the diagnosis of rectosigmoid endometriosis with rectal water contrast transvaginal ultrasonography (rectosonography).

This study aimed to evaluate the value of an e-learning program for the diagnosis of rectosigmoid endometriosis lesions using rectal water contrast transvaginal ultrasonography (rectosonography/RSG). Theoretical RSG training using videos with a commentary was offered online to healthcare professionals involved in ultrasound screening for endometriosis. A test (without correction) with 24 RSG video loops was used to assess the participants' baseline level before the training and their improvement afterwards. If the success rate post-training was below 80 %, the participant could start over with another series of 24 videos. Between February and June 2020, thirty participants took the training course (of which 80 % were obstetrics-gynaecology residents). The e-learning program resulted in a significant performance increase in the diagnosis of rectosigmoid endometriosis lesions, with a higher test success rate after the training compared to before (74.4 % and 63.6 % respectively; +10.8 %; 95 % CI [6,6; 15]; p < 0.001). Significant improvement was also observed regarding the overall skills involved in the ultrasound diagnosis of deep infiltrating endometriosis (+9.2 %; p < 0.001), the accurate diagnosis of the height of bowel lesions (+14.7 %; p < 0.001) and uterosacral ligament lesions (+8%; p < 0.005). In conclusion, our e-learning program led to a significant improvement of the diagnostic performance of digestive endometriosis using transvaginal ultrasound with intrarectal water contrast (rectosonography). Adding feedback to the post-test video loops could further increase the efficacy of the e-learning training.

Diagnostic Performances of Tridimensional Rectosonography and Magnetic Resonance Imaging in Rectosigmoid Endometriosis: A Prospective Cohort Study on 101 Patients.

Tridimensional rectosonography (3-D RSG) is a transvaginal ultrasonography procedure combining intrarectal contrast with tridimensional technology. The objectives of this study were to assess the diagnostic performances of 3-D RSG in deep infiltrating rectosigmoid endometriosis using surgery and pathology as the gold standard, and to compare its results with those of magnetic resonance imaging (MRI). Patients referred for endometriosis with symptoms suggesting deep infiltrating intestinal endometriosis (DIE) were included if they agreed to undergo a 3-D RSG and MRI and if there was a surgical indication related to endometriosis. The study was a non-randomized monocentric prospective cohort study (Canadian task force classification Level II-2). From May 2012 to May 2017, 101 patients were included. Sixty patients (59.4%) had bowel involvement of the rectum (n = 21, 20.8%) or of the sigmoid (n = 39, 38.6%) confirmed in surgery and/or in pathologic testing. In the diagnosis of rectosigmoid DIE, 3-D RSG sensitivity, specificity, positive predictive value, negative predictive value, accuracy and κ index were 93%, 95%, 97%, 91%, 94% and 0.88, respectively. For MRI they were 87%, 90%, 93%, 82%, 88% and 0.76, respectively. The accuracy was not significantly different between 3-D RSG and MRI (p = 0.181). In conclusion, 3-D RSG is an effective technique to diagnose rectosigmoid endometriosis and seems to have similar diagnostic performances to MRI for this indication.