Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3).

STUDY QUESTION: Does linzagolix administered orally once daily for up to 3 months at a dose of 75 mg alone or 200 mg in combination with add-back therapy (ABT) (1.0 mg estradiol; 0.5 mg norethindrone acetate, also known as norethisterone acetate [NETA]) demonstrate better efficacy than placebo in the management of endometriosis-related dysmenorrhea and non-menstrual pelvic pain? SUMMARY ANSWER: Combining 200 mg linzagolix with ABT was found to significantly reduce dysmenorrhea and non-menstrual pelvic pain at 3 months of therapy, while a daily dose of 75 mg linzagolix yielded a significant decrease only in dysmenorrhea at 3 months. WHAT IS KNOWN ALREADY?: A previously published Phase 2, dose-finding study reported that at a dose of 200 mg daily, linzagolix promotes full suppression of estradiol secretion to serum levels below 20 pg/ml and noted that the addition of ABT may be needed to manage hypoestrogenic side effects. At lower doses (75 mg and 100 mg/day), linzagolix maintains estradiol values within the target range of 20-60 pg/ml, which could be ideal to alleviate symptoms linked to endometriosis. STUDY DESIGN, SIZE, DURATION: EDELWEISS 3 was a multicenter, prospective, randomized, placebo-controlled, double-blind, double-dummy Phase 3 study to evaluate the safety and efficacy of linzagolix for the treatment of moderate-to-severe endometriosis-associated pain. Treatment was administered orally once daily for up to 6 months. PARTICIPANTS/MATERIALS, SETTING, METHODS: In the EDELWEISS 3 trial, 486 subjects with moderate-to-severe endometriosis-associated pain were randomized at a 1:1:1 ratio to one of the three study groups: placebo, 75 mg linzagolix alone or 200 mg linzagolix in association with ABT. Pain was measured daily on a verbal rating scale and recorded in an electronic diary. MAIN RESULTS AND THE ROLE OF CHANCE: At 3 months, the daily 200 mg linzagolix dose with ABT met the primary efficacy objective, showing clinically meaningful and statistically significant reductions in dysmenorrhea and non-menstrual pelvic pain, with stable or decreased use of analgesics. The proportion of responders for dysmenorrhea in the 200 mg linzagolix with ABT group was 72.9% compared with 23.5% in the placebo group (P < 0.001), while the rates of responders for non-menstrual pelvic pain were 47.3% and 30.9% (P = 0.007), respectively. The 75 mg linzagolix daily dose demonstrated a clinically meaningful and statistically significant reduction in dysmenorrhea versus placebo at 3 months. The proportion of responders for dysmenorrhea in the 75 mg linzagolix group was 44.0% compared with 23.5% in the placebo group (P < 0.001). Although the 75 mg dose showed a trend toward reduction in non-menstrual pelvic pain at 3 months relative to the placebo, it was not statistically significant (P = 0.279). Significant improvements in dyschezia and overall pelvic pain were observed in both linzagolix groups when compared to placebo. Small improvements in dyspareunia scores were observed in both linzagolix groups but they were not significant. In both groups, hypoestrogenic effects were mild, with low rates of hot flushes and bone density loss of <1%. A daily dose of 200 mg linzagolix with ABT or 75 mg linzagolix alone was found to significantly reduce dysmenorrhea and non-menstrual pelvic pain also at 6 months of therapy. LIMITATIONS, REASONS FOR CAUTION: Efficacy was compared between linzagolix groups and placebo; however, it would be useful to have results from comparative studies with estro-progestogens or progestogens. It will be important to ascertain whether gonadotropin-releasing hormone antagonists have significant benefits over traditional first-line medications. WIDER IMPLICATIONS OF THE FINDINGS: Linzagolix administered orally once daily at a dose of 200 mg in combination with add-back therapy (ABT) demonstrated better efficacy and safety than placebo in the management of moderate-to-severe endometriosis-associated pain. The quality of life was improved and the risks of bone loss and vasomotor symptoms were minimized due to the ABT. The 75 mg dose alone could be suitable for chronic treatment of endometriosis-associated pain without the need for concomitant hormonal ABT, but further research is needed to confirm this. If confirmed, it would offer a viable option for women who do not want to wish to have ABT or for whom it is contraindicated. STUDY FUNDING/COMPETING INTEREST(S): Funding for the EDELWEISS 3 study was provided by ObsEva (Geneva, Switzerland). Analysis of data and manuscript writing were partially supported by ObsEva (Geneva, Switzerland), Theramex (London, UK) and Kissei (Japan) and grant 5/4/150/5 was awarded to M.-M.D. by FNRS. J.D. was a member of the scientific advisory board of ObsEva until August 2022, a member of the scientific advisory board of PregLem, and received personal fees from Gedeon Richter, ObsEva and Theramex. J.D. received consulting fees, speakers' fees, and travel support from Gedeon Richter, Obseva and Theramex, which was paid to their institution. C.B. has received fees from Theramex, Gedeon Richter, and Myovant, and travel support from Gedeon Richter-all funds went to the University of Oxford. He was a member of the data monitoring board supervising the current study, and served at an advisory board for endometriosis studies of Myovant. H.T. has received grants from Abbvie and was past president of ASRM. F.C.H. has received fees from Gedeon Richter and Theramex. O.D. received fees for lectures from Gedeon Richter and ObsEva and research grants for clinical studies from Preglem and ObsEva independent from the current study. A.H. has received grants from NIHR, UKRI, CSO, Wellbeing of Women, and Roche Diagnostics; he has received fees from Theramex. A.H.'s institution has received honoraria for consultancy from Roche Diagnostics, Gesynta, and Joii. M.P. has nothing to declare. F.P. has received fees from Theramex. S.P.R. has been a member of the scientific advisory board of Gedeon Richter and received fees from Gedeon Richter. A.P. and M.B. are employees of Theramex. E.B. was an employee of ObsEva, sponsor chair of the data monitoring board supervising the current study, and has been working as a consultant for Theramex since December 2022; she owns stock options in ObsEva. M.-M.D. has received fees and travel support from Gedeon Richter and Theramex. TRIAL REGISTRATION NUMBER: NCT03992846. TRIAL REGISTRATION DATE: 20 June 2019. DATE OF FIRST PATIENT'S ENROLLMENT: 13 June 2019.

Cesarean scar disorder: Management and repair.

Cesarean scar disorder (CSD) is an entity recently defined as uterine niche with at least one primary or 2 secondary symptoms. CSDs can be visualized by hysterosalpingography, transvaginal sonography, saline infusion sonohysterography, hysteroscopy, and magnetic resonance imaging, but diagnosis should be performed by exams able to measure the residual myometrial thickness (RMT). Although there is a limited number of studies evaluating fertility and reproductive outcomes after different types of surgery, the following consideration should be kept in mind. Asymptomatic women should not be operated with the hope of improving obstetrical outcomes. It is reasonable to consider hormone therapy for CSDs as a symptomatic treatment in women who no longer wish to conceive and have no contraindications. In case of failure of or contraindications to medical treatment, surgery should be offered according to the severity of symptoms, including infertility, the desire or otherwise to preserve the uterus, the size of the CSD, and RMT measurement. Hysteroscopy is considered to be more of a resection than a repair, so women who desire pregnancy should be excluded from this technique in case of RMT <3 mm. In this instance, repair is essential and can only be achieved by a laparoscopic or vaginal approach. The benefit of laparoscopic approach seems to persist after subsequent CS. Women with CSDs need to be given complete information, including available literature, before any treatment decision is made.

Can uterine niche be prevented?

Uterine niche is a potential significant consequence of Caesarean section and is diagnosed by ultrasound. The timing of Caesarean section (during pre, early or advanced labour), location of the incision (distance from the internal os), techniques for opening and closing the uterine cavity, and bladder flap have been frequently mentioned in the literature, however, these factors continue to be a source of disagreement with respect to whether they increase the risk of uterine niche or protect against this complication. In this review, we outline and discuss the possible risk factors that may be responsible for this entity. The main factor upon which obstetricians can act is the rate of first Caesarean section, which can and should be reduced. Moreover, a rather high incision at a distance from the internal os, and a sparing use of bladder detachment should be always kept in mind as well.

Treatment of symptomatic uterine adenomyosis with linzagolix, an oral gonadotrophin-releasing hormone antagonist: a pilot study.

RESEARCH QUESTION: Does a once-daily regimen of linzagolix, a new oral gonadotrophin-releasing hormone (GnRH) antagonist, given at a fully suppressive dose (200 mg) for 12 weeks, followed by a partially suppressive dose (100 mg) for a further 12 weeks, reduce adenomyotic uterine size and associated symptoms? DESIGN: Eight women (aged 37-45 years) with adenomyosis confirmed by magnetic resonance imaging (MRI) were enrolled in a single-centre, open-label pilot study. The primary efficacy end-point was the change in uterine volume on MRI at 24 weeks. Secondary efficacy end-points included serum oestradiol, overall pelvic pain, dysmenorrhoea, non-menstrual pelvic pain, dyspareunia, dyschezia and quality of life (QoL). Bone mineral density (BMD) was assessed at baseline and 24 weeks. RESULTS: At baseline, uterine volume (mean ± SD) was 333 ± 250 cm3. After 24 weeks, it was 204 ± 126 cm3, a reduction of 32% from baseline (P = 0.0057). After 12 weeks, it was 159 ± 95 cm3, a reduction of 55% (P < 0.0001). Median serum oestradiol was suppressed below 20 pg/ml during the 12 weeks on 200 mg linzagolix, and maintained below 60 pg/ml on 100 mg linzagolix. Improvements in overall pelvic pain, dysmenorrhoea, non-menstrual pelvic pain, dyspareunia, dyschezia and QoL were observed. Mean percentage change in BMD loss at 24 weeks was -2.4%, -1.3% and -4.1% for the spine, femoral neck and total hip, respectively. The most common adverse events were hot flushes. CONCLUSIONS: A once-daily regimen of 200 mg linzagolix for 12 weeks and then 100 mg for another 12 weeks decreased adenomyotic uterine volume and improved associated symptoms.

Uterine Adenomyosis Treated by Linzagolix, an Oral Gonadotropin-Releasing Hormone Receptor Antagonist: A Pilot Study with a New 'Hit Hard First and then Maintain' Regimen of Administration.

(1) Background: The aim of the present pilot study was to study the effect of a new oral gonadotropin-releasing hormone antagonist on adenomyosis. (2) Methods: Eight premenopausal women, aged between 37 and 45 years, presenting with heavy menstrual bleeding, pelvic pain, and dysmenorrhea due to diffuse and disseminated uterine adenomyosis, confirmed by magnetic resonance imaging (MRI), received 200 mg linzagolix once daily for a period of 12 weeks, after which they were switched to 100 mg linzagolix once daily for another 12 weeks. The primary efficacy endpoint was the change in volume of the adenomyotic uterus from baseline to 24 weeks, evaluated by MRI. Secondary efficacy endpoints included the change in uterine volume from baseline to 12 and 36 weeks by MRI, and also weeks 12, 24, and 36 assessed by transvaginal ultrasound (TVUS). Other endpoints were overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain, dyspareunia, amenorrhea, quality of life measures, bone mineral density (BMD), junctional zone thickness, and serum estradiol values. (3) Results: Median serum estradiol was suppressed below 20 pg/mL during the 12 weeks on linzagolix 200 mg, and maintained below 60 pg/mL during the second 12 weeks on linzagolix 100 mg. At baseline, the mean ± SD uterine volume was 333 ± 250 cm3. After 24 weeks of treatment, it was 204 ± 126 cm3, a reduction of 32% (p = 0.0057). After 12 weeks, the mean uterine volume was 159 ± 95 cm3, a reduction of 55% from baseline (p = 0.0001). A similar pattern was observed when uterine volume was assessed by TVUS. Improvements in overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain, dyspareunia, and dyschezia, as well as quality of life measured using the EHP-30 were also observed. Mean percentage BMD loss at 24 weeks was, respectively, -2.4%, -1.3%, and -4.1% for the spine, femoral neck, and total hip. The most common adverse events were hot flushes, which occurred in 6/8 women during the first 12 weeks, and 1/8 women between 12 and 24 weeks. (4) Conclusions: Linzagolix at a dose of 200 mg/day reduced uterine volume, and improved clinically relevant symptoms. Treatment with 100 mg thereafter retains the therapeutic benefits of the starting dose while minimizing side effects. This 'hit hard first and then maintain' approach may be the optimal way to treat women with symptomatic adenomyosis.

Conservative Management of Rectovaginal Deep Endometriosis: Shaving Should Be Considered as the Primary Surgical Approach in a High Majority of Cases.

Deep endometriosis infiltrating the rectum remains a challenging situation to manage, and it is even more important when ureters and pelvic nerves are also infiltrated. Removal of deep rectovaginal endometriosis is mandatory in case of symptoms strongly impairing quality of life, alteration of digestive, urinary, sexual and reproductive functions, or in case of growing. Extensive preoperative imaging is required to choose the right technique between laparoscopic shaving, disc excision, or rectal resection. When performed by skilled surgeons and well-trained teams, a very high majority of cases of deep endometriosis nodule (>95%) is feasible by the shaving technique, and this is associated with lower complication rates regarding rectal resection. In most cases, removing a part of the rectum is questionable according to the risk of complications, and the rectum should be preserved as far as possible. Shaving and rectal resection are comparable in terms of recurrence rates. As shaving is manageable whatever the size of the lesions, surgeons should consider rectal shaving as first-line surgery to remove rectal deep endometriosis. Rectal stenosis of more than 80% of the lumen, multiple bowel deep endometriosis nodules, and stenotic sigmoid colon lesions should be considered as indication for rectal resection, but this represents a minority of cases.

Deep endometriosis: The place of laparoscopic shaving.

Deep endometriosis (DE) is considered to be one of the most challenging conditions to manage, especially when it invades surrounding organs like the rectum. Surgical excision of deep rectovaginal endometriosis is required when lesions are symptomatic, impairing bowel, urinary, sexual, and reproductive functions, or if they evolve. Preoperative radiological examination should be extensive to determine the appropriate surgery: laparoscopic shaving, disc excision, or rectal resection. We demonstrated that in the hands of experienced surgeons, rectal shaving is possible for DE in more than 95% of cases, with low complication rates compared to rectal resection. Shaving and bowel resection are associated with comparable recurrence rates. As shaving is indicated whatever the size of deep lesions, surgeons should first consider rectal shaving to remove DE. Bowel resection should only be performed in case of major rectal stenosis (>80%), multiple and/or posterior rectal lesions and stenotic sigmoid colon lesions.

Gonadotropin-releasing hormone antagonist (linzagolix): a new therapy for uterine adenomyosis.

OBJECTIVE: To compare the efficacy of a selective progesterone receptor modulator, ulipristal acetate, and a gonadotropin-releasing hormone antagonist, linzagolix, in a case of severe uterine adenomyosis. DESIGN: Case report. SETTING: Private clinic and infertility research unit. PATIENT: One patient born in 1981 who presented because of heavy menstrual bleeding, pelvic pain, and dysmenorrhea due to diffuse and disseminated uterine adenomyosis confirmed by magnetic resonance imaging (MRI). INTERVENTION: The patient received a first treatment of 5 mg UPA daily for one course of 3 months. This therapy was discontinued because MRI revealed a worsened aspect. One year later, a once-daily dose of 200 mg linzagolix administered orally was initiated for 3 months, followed by another 3-month course of 100 mg once daily. MAIN OUTCOME MEASURES: Clinical symptoms and MRI aspect. RESULTS: During treatment with UPA, the symptoms (pelvic pain, dysmenorrhea, bulk symptoms) worsened and MRI revealed aggravation of the adenomyotic lesions. During the 12-week course of once-daily 200 mg linzagolix, the patient remained in amenorrhea and noted a very significant improvement in symptoms. On MRI, the uterine volume had fallen from 875 cm3 to 290 cm3, and the adenomyotic lesions had significantly regressed. During the 100-mg linzagolix course (weeks 13-24), the patient reported continued alleviation of her symptoms. CONCLUSION: To our knowledge, this is the first reported use of linzagolix, a new oral gonadotropin-releasing hormone antagonist that significantly reduced lesion size and improved quality of life in a patient with severe adenomyosis, who was previously nonresponsive to treatment with a selective progesterone receptor modulator, ulipristal acetate.

Cesarean scar defects: management of an iatrogenic pathology whose prevalence has dramatically increased.

Around 20% of pregnant women undergo cesarean section (CS), and in most regions of the world CS rates continue to grow. There is still no clear definition of what is considered a normal physiologic aspect of a CS scar and what is abnormal. Cesarean scar defects (CSDs) should be suspected in women presenting with spotting, dysmenorrhea, pelvic pain, or infertility and a history of CS. CSDs can be visualized with the use of hysterosalpingography, transvaginal sonography, saline infusion sonohysterography, hysteroscopy, and magnetic resonance imaging. It is reasonable to consider hormone therapy for CSDs as a symptomatic treatment in women who no longer wish to conceive and have no contraindications. In case of failure of or contraindications to medical treatment, surgery should be contemplated according to the severity of symptoms, including infertility, the desire or otherwise to preserve the uterus, the size of the CSD, and residual myometrium thickness (RMT) measurement. Hysteroscopy is considered to be more of a resection than a repair, so women who desire pregnancy should be excluded from this technique if the RMT is <3 mm, in which case repair is essential and can be achieved by only laparoscopic or vaginal approach. Women with CSDs need to be given complete information, including available literature, before any treatment decision is made. Because prevention is better than cure, risk factors should be identified early to ensure appropriate management.

Effect on surgical decisions: Ulipristal acetate as key player in Belgian phase IV registration trial.

OBJECTIVE: To observe alterations in surgical planning that were due to the use of ulipristal acetate (UPA) 5 mg daily for symptomatic uterine fibroids. METHODS: A prospective cohort trial involving women with symptomatic fibroids was undertaken in 23 clinical practice sites within Belgium between October 1, 2014, and March 31, 2016, to compare initial surgical planning to performed surgical procedures following the use of UPA 5 mg daily for 3 months. Secondary outcomes were surgical complications, reduction in fibroids, bleeding control, and adverse effects. RESULTS: Two hundred and twenty-two women were recruited for the trial. The requirement for surgery decreased with the use of UPA, with 54% of women undergoing surgery after treatment. The reduction in surgery performed was lower for women willing to conceive (40%) compared to women who were not (49%). The volume of the fibroids decreased significantly, with the largest measured fibroid decreasing by 50%. Bleeding and pain were significantly decreased with the use of UPA. No major complications were recorded, and no liver function abnormalities were reported during the treatment and in follow-up. CONCLUSION: By administering UPA, the required rate of surgery was significantly decreased. Also, the resulting reduction in size of the fibroids could have the potential benefit of reducing surgery-related complications, and long-term use may be warranted to avoid surgery completely.

Invasion of human deep nodular endometriotic lesions is associated with collective cell migration and nerve development.

OBJECTIVE: To study the mechanisms of invasion and innervation of deep endometriosis in women. DESIGN: Morphologic and immunohistochemical analysis of human endometriotic lesions. SETTING: Academic research unit. PATIENT(S): Seventeen biopsy samples of deep endometriotic lesions were collected from patients undergoing surgery for deep endometriosis. INTERVENTION(S): The endometriotic samples were divided into two parts: the front (the most invasive area of lesions, approaching rectal infiltration) and center (the area close to the posterior part of the cervix). MAIN OUTCOME(S): To elucidate: gland morphology, proliferation, and expression of adhesion molecules (ß-catenin, E-cadherin, and N-cadherin) to determine the possible role of collective cell migration (CCM) in the invasion process; and nerve growth factor (NGF) and nerve fiber density (NFD) values to shed further light on the mechanism of innervation. RESULTS: Glands from the front showed significantly reduced thickness, but significantly higher proliferation. ß-Catenin expression was similar between the lesion center and front. E-cadherin levels were significantly lower and N-cadherin levels significantly higher in glands located at the front of the lesions. Expression of matrix metalloproteinase-9 was significantly higher in glands and stromal cells located at the invasion front. NFD and NGF expression were also significantly higher at the lesion front. CONCLUSION: Although some data in the literature point to features of epithelial to mesenchymal transition in human deep nodular endometriosis, our study suggests that gland invasion in these lesions is dominated by CCM. Innervation of deep nodular endometriotic lesions may be a consequence of nerve recruitment from surrounding organs.

Ulipristal acetate for the management of large uterine fibroids associated with heavy bleeding: a review.

Ulipristal acetate (UPA), a selective progesterone receptor modulator (SPRM), offers new therapeutic options for the clinical management of large uterine fibroids associated with heavy menstrual bleeding or with other moderate or severe symptoms (bulk symptoms, pelvic pain, decreased quality of life). SPRM are synthetic compounds that exert an agonist or antagonist effect on target tissues by their binding to progesterone receptors. UPA reduces fibroid size, controls bleeding in a high percentage of women and significantly improves quality of life. The present review aims to provide insights into UPA indications and its mechanism of action.

Introduction: Uterine adenomyosis, another enigmatic disease of our time.

Like endometriosis, uterine adenomyosis is another enigmatic disease and remains a source of controversy. Uterine adenomyosis is characterized by the presence of endometrial glands in the myometrium. Two main theories may explain its pathogenesis: adenomyosis may arise from invagination of the myometrial basalis into the myometrium; or an alternative theory maintains that it may result from metaplasia of displaced embryonic pluripotent müllerian remants or differentiation of adult stem cells. Uterine adenomyosis is responsible for pelvic pain, abnormal bleeding, and infertility. Its diagnosis may be improved by high quality imaging. This issue's Views and Reviews, authors stress the urgent need to establish some systematic classification. Medical and surgical strategies are discussed. It should be emphasized that treatment should be designed according to a patient's symptoms and an individual's needs. Surgical treatment remains a matter of debate. Indeed, the risk of uterine rupture during pregnancy after adenomyomectomy is a reality. Therefore, continued research into new molecules based on the pathogenic mechanisms is vital.

Emerging treatment options for uterine fibroids.

INTRODUCTION: Uterine fibroids (also known as leiomyomas or myomas) are the most common form of benign uterine tumors. Current management strategies involve mainly surgical interventions, but the choice of treatment is guided by patient age and desire to preserve fertility or avoid 'radical' surgery such as hysterectomy. Areas covered: There is growing evidence of the crucial role of progesterone pathways in the pathophysiology of uterine fibroids, leading to increasing use of selective progesterone receptor modulators (SPRMs) such as ulipristal acetate. We searched all published studies on medical management of fibroids with SPRMs. Expert opinion: The need for alternatives to surgical intervention is very real, especially for women seeking to preserve their fertility. These options now exist, with SPRMs proven to treat fibroid symptoms effectively. Gynecologists now have new tools in their armamentarium, opening up novel strategies for the management of uterine fibroids.

Pathogenesis of uterine adenomyosis: invagination or metaplasia?

Adenomyosis is a commonly diagnosed estrogen-dependent gynecological disorder that causes pelvic pain, abnormal uterine bleeding, and infertility. Despite its prevalence and severity of symptoms, its pathogenesis and etiology have not yet been elucidated. The aim of this manuscript is to review the different hypotheses on the origin of adenomyotic lesions and the mechanisms involved in the evolution and progression of the disease. Two main theories have been proposed to explain the origin of adenomyosis. The most common suggests involvement of tissue injury and the repair mechanism and claims that adenomyosis results from invagination of the endometrial basalis into the myometrium. An alternative theory maintains that adenomyotic lesions result from metaplasia of displaced embryonic pluripotent Müllerian remnants or differentiation of adult stem cells. Previous investigations performed in human adenomyotic lesions and corroborated by studies in mice supported the involvement of the epithelial-mesenchymal transition process in the early stages of progression and spread of adenomyosis. However, studies conducted in a recently developed baboon model indicate that collective cell migration may be implicated in the later events of invasion. This suggests that the invasiveness of this complex uterine disorder is not driven by a single mechanism of migration but by a time-dependent combination of two processes.

Hypnosis as adjunct therapy to conscious sedation for venous access device implantation in breast cancer: A pilot study.

BACKGROUND: Recent reviews support that hypnosis has great potential for reducing pain and anxiety during mini-invasive surgery. Here, we assessed the feasibility of hypnotic induction session as adjunct therapy in conscious sedation for venous access device implantation. Primary outcomes were safety and patient satisfaction. METHODS: Thirty consecutive women with breast cancer were proposed adjunct of hypnosis before implantation under conscious sedation (midazolam: 0.5 mg ± bolus of Ketamin: 5 mg on demand) indicated for chemotherapy. Self-hypnosis was programmed and guided by one of two trained anesthesiologists. Implantation was performed by one of two experimented surgeons. It consisted of blind subclavian implantation of Braun ST 305 devices using a percutaneous technique adapted from Selinger's procedure. Clinical data were prospectively collected and retrospectively analyzed. A comprehensive custom-made questionnaire recorded patient satisfaction. RESULTS: In all, 30/30 patients consented to the procedure. The median age was 54 years (range: 35-77 years). The primary procedure was successful in 29/30. One case was converted into internal jugular vein access after a first attempt. Median length time of the implantation procedure in the operative room was 20 min (range: 10-60 min). Median length time in the recovery room preceding home discharge was 65 min (range: 15-185 min). None of the patients suffered complications. The satisfaction rate was ≥90%, 27/30 patients would get hypnosis in case of reimplantation if necessary and 27/30 would recommend this procedure to others. CONCLUSION: Hypnosis under conscious sedation appears feasible and safe for port implantation under conscious sedation in cancer patients. Further studies would determine the exact value of hypnosis effectiveness.