Isthmic retroperitoneal cerclage via vNOTES as a potential alternative to an abdominal cerclage: First technique description.

OBJECTIVE: To describe a new technique for performing an isthmic retroperitoneal cerclage via vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). DESIGN: Stepwise explanation of the surgical technique using original video footage. This study was exempted from requiring hospital IRB. SETTING: Department of Obstetrics and Gynaecology, Imelda Hospital, Belgium. INTERVENTION: A circumferential vaginal incision is made around the cervix after infiltration of the tissue with local anaesthetic and adrenaline. The bladder is deflected from the cervix up to the level of the isthmus but the peritoneum is not opened. The rectum is deflected from the cervix up to the level of the isthmus but the peritoneum is not opened. A Gelpoint vPath (9.5 cm) (Applied Medical, Rancho Santa Margarita) is used as a vNOTES port. The inner ring of the Alexis is inserted into the retroperitoneal dissection space around the cervix, covering the bladder anteriorly and the rectum posteriorly. An insufflation stabilization bag (ISB) is connected to the Gelseal cap to minimize pressure fluctuations within the confines of the retroperitoneal operative space. The paracervical space is opened just inferior to the uterine artery. A paracervical tunnel is made from the anterior to the posterior retroperitoneal space just lateral to the cervix and just inferior to the uterine artery. This procedure is performed bilaterally. A vessel loop is inserted from anterior to posterior through the paracervical tunnel on each side of the cervix. The Gelseal cap is removed and an Ethibond-2 suture is tied to the vessel loop. The Gelseal cap is placed again. By pulling on the vessel loop, it is replaced by the Ethibond suture. The Ethibond suture is now tied endoscopically to complete the cerclage; alternatively the suture could be tied vaginally without endoscopic instruments to the surgeon's preference. The vNOTES port is removed and the vaginal mucosa is sutured to the cervix again using a resorbable suture. DISCUSSION: Abdominal cerclage is the preferred approach to treat patients with refractory cervical insufficiency [1]. Over the last 20 years this technique increasingly gets performed laparoscopically with similar success rates [2]. The new transvaginal approach demonstrated in this video article may help reduce the invasivess even more by avoiding abdominal incisions and opening the peritoneum, while still benefiting from the vNOTES endoscopic visualization and minimally invasive instruments [3]. The cerclage is placed permanently at the level of the isthmus, similar to an abdominal cerclage. It is placed more cranially than a McDonald or Shirodkar cerclage and leaves no non-resorbable sutures in the vagina [4]. It can be an alternative to a conventional transvaginal cervicoisthmic cerclage [5,6] in patients with a narrow vagina and without uterine descensus. Following the guidelines of the IDEAL collaboration we present this technique to be peer reviewed in its early developmental phase before starting further studies [7]. CONCLUSION: This is a first feasibility and technique description report on performing a retroperitoneal isthmic cervical via vNOTES. This technique should be considered new, not to be performed on pregnant patients or outside of clinical trials, and only in carefully counselled patients.

Standardised step by step approach to adnexectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery.

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) combines the advantages of vaginal surgery with those of laparoscopic surgery. Feasibility of vNOTES for other indications such as hysterectomy, ovarian cystectomy and myomectomy has been established. In this article, we describe a standardised step by step process to perform adnexal surgery by vNOTES.

Consensus on safe implementation of vaginal natural orifice transluminal endoscopic surgery (vNOTES).

STUDY OBJECTIVE: The first ever report of vaginal natural orifice transluminal endoscopic surgery (vNOTES) for benign gynaecological was reported in 2012. There has been an exponential uptake of the number of surgeons performing such procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynaecological practice due its recency. The objective of this study is to report an international consensus-based statement to help guide a basis for adopting vNOTES into clinical practice. STUDY DESIGN: The consensus-based statement was developed amongst 39 international experts using the Delphi methodology over three successive rounds. Consensus was pre-defined as an agreement of 80% or more by the experts. Consensus sought over eight key concepts pertaining to vNOTES including patient selection, perioperative management, surgical technique, instruments, anatomy, training, registries and trials and definition of the surgical technique. Recommendations from an expert anaesthetist and urogynaecologist were also sought to give a broader perspective with respect to the implementation of vNOTES. RESULTS: Fifty nine international surgeons were invited to participate and 39 (66%) agreed to participate based on being involved in a minimum of 20 vNOTES procedures. They were from 13 countries across 5 continents (Europe, North America, South America, Australia and Asia). Participation was 100% on all three rounds. Overall, consensus was reached in 50 of the 56 questions (89%) with the remaining 6 questions where consensus was not reached pertaining to the domain of patient selection. CONCLUSION: An international expert based vNOTES statement is presented here to help guide adoption of vNOTES based on the experience of early adopters. Consensus was achieved on most components of this consensus statement. Given the recency of this technique, until high-level evidence becomes available, this statement provides an appropriate guidance to the safe implementation of vNOTES into gynaecological practice.

Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial).

OBJECTIVE: To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy. DESIGN: Parallel group, 1:1 single-centre single-blinded randomised trial, designed as non-inferiority study with a margin of 15%. SETTING: Belgian teaching hospital. POPULATION: Non-pregnant non-virgin women with an intact uterus and without obliteration of the pouch of Douglas scheduled to undergo removal of an adnexal mass assessed to be benign on ultrasound by IOTA criteria. METHODS: Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions. MAIN OUTCOME MEASURES: The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and analgesics used, quality of life and adverse events. RESULTS: We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary end point was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 13%, which is below the predefined non-inferiority margin of 15%. The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a trend for more adverse events in the vNOTES group. CONCLUSIONS: vNOTES is non-inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times and less postoperative pain but there was a trend for more adverse events.

Easy way to perform salpingectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) (with video).

The transvaginal natural orifice transluminal endoscopic surgery (vNOTES) is a new minimally invasive and emerging technique. Feasibility and safety profiles of peritoneal access via transvaginal routes have been demonstrated especially for the adnexal surgery. In order to be reproducible and replicable with a standardized procedure, we propose the step-by-step video description of the vNOTES salpingectomy. The advantages of the vNOTES (low postoperative pain, faster postoperative recovery, scarless surgery) could lead to a promising alternative to conventional laparoscopic salpingectomy/adnexectomy.

Benign Gynaecological procedures by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES): Complication data from a series of 1000 patients.

STUDY OBJECTIVE: To evaluate the safety and feasibility of vaginal natural orifice transluminal endoscopic surgery (vNOTES) for benign gynaecological indications. STUDY DESIGN: Prospective observational study (Canadian Task Force classification II-3) in a non-university teaching hospital. One thousand consecutive patients (2013-2018) who were eligible for vNOTES approach to benign gynaecological surgery were included. RESULTS: Patient data and perioperative outcomes were included for analysis after the vNOTES surgical approach was standardized and made the default route of surgery. Of the 1000 vNOTES cases performed during this study period, hysterectomy (73%) was the most common followed by adnexal surgery (18%) and salpingectomy (4%). The mean age of the patient cohort was 46 yrs of age (22-83) and mean BMI, 26 kg/m2(16.5-52). There was a conversion rate of 0.4% (4 cases), 3 to conventional laparoscopy and 1 to laparotomy. The mean operating time was 42 minutes (14-250 minutes). The total complication rate was 3.9% (39) of which 1% (10) was intraoperative complications and 2.9% (29) were post-operative complications. When the hysterectomy cohort was sub analyzed, the total complication rate was 5.2% in this group (intraoperative 1.4% and post-operative 3.8%) with only a 0.4% complication rate in the non-hysterectomy sub-group. Of the complications in the hysterectomy group there were 9 cystotomies (1.2%). The mean specimen weight for all hysterectomies was 172 g (20-3361 g) with an average operating time of 46 minutes (20-250). CONCLUSION: The perioperative outcomes of this large vNOTES case series for benign gynaecological indications is comparable to other vNOTES procedures reported in the literature apart from the risk of cystotomy which is a hysterectomy specific risk. The outcomes are that of a single high-volume surgeon incorporating cases within his respective learning curve of the surgical technique and as such should be interpreted accordingly. Since 2015 the International NOTES Society has initiated a prospective complication database where all vNOTES surgeons are invited to register their cases.

Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial.

OBJECTIVE: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure. DESIGN: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%. SETTING: Belgian teaching hospital. POPULATION: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications. METHODS: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors. MAIN OUTCOME MEASURES: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes. RESULTS: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004. CONCLUSIONS: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting. TWEETABLE ABSTRACT: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.

Uterine smooth muscle tumors of uncertain malignant potential: analysis of diagnoses and therapies illustrated by two case reports.

Uterine smooth muscle tumors of uncertain malignant potential, or STUMP, form a rare group of tumors that fall neither into the benign nor malignant categories. Two cases are reported, describing diagnosis, known prognostic factors, and therapy. In contrast to leiomyomas and leiomyosarcomas, many uncertainties still exist concerning prognosis and postoperative management of STUMP, because of their rarity. Diagnosis is usually not made preoperatively, but by postoperative anatomo-pathological examination. There are histological and immunohistochemical factors that could be associated with a worse prognosis, but scientific evidence is insufficient. Most cases show a low risk of recurrence, although individual risk is unpredictable. Recurrences mostly occur after a long disease-free interval. A conservative approach with strict long-term clinical follow-up is therefore indicated. Further research must be conducted to identify surgical procedures that have a higher risk for recurrence. After a laparoscopy, where the specimen was morcellated, the possibility of peritoneal spread and the difficulty in examining section margins, need to be taken into account. Further treatment therefore needs to be individualized.

Squamous cell carcinoma in situ lining the uterine cavity.

Cervical intra-epithelial neoplasia is a very common and well-known pathology. However superficial spreading of this lesion is very rare. The authors present a case of a 72-year-old woman with an abdominal mass, who had previously undergone a cervical conisation for a high-grade cervical intra-epithelial neoplasia. Anatomo-pathological examination of the mass showed a large distended fluid-filled uterus with the entire endometrium replaced by a high-grade squamous cell lesion. There were only micro-invasive foci found. The authors performed a literature search in PubMed with the following MeSH-terms: "squamous cell carcinoma" and "endometrium". Other articles were selected out of the references of previously found articles. Only 31 similar cases were found. The presentation of the cases is varies extremely and a long-term prognosis is not yet known.

Laparoscopic endopelvic sacral implantation of a Brindley controller for recovery of bladder function in a paralyzed patient.

BACKGROUND: A number of techniques are being investigated to accomplish bladder control recovery in paralyzed patients using the neurostimulation, but currently, all techniques are based on the dorsal implantation of the electrodes using a laminectomy. METHODS: On 27 April 2006 we performed a laparoscopic implantation of a Finetech-Brindley bladder controller on the endopelvic sacral roots in a Th8 completely paralyzed woman who had previously undergone the removal of a Brindley controller due to an arachnoiditis after extrathecal implantation with intradural sacral deafferentation. RESULTS: We required about 3.5 h for the entire surgical procedure; no complications occurred and the patients went home on 5th postoperative day. The patient is now able to void empty her bladder and her rectum using the controller without further need for self-catheterisation. CONCLUSIONS: The presented new technique of laparoscopic implantation of electrodes on the endopelvic portion of the sacral nerve roots is an option to be considered in all paralyzed patients with further wish for electrical induced miction/defecation after previous deafferentation.

Laparoscopic neurolysis of the sacral plexus and the sciatic nerve for extensive endometriosis of the pelvic wall.

BACKGROUND: The aim of this study is to report on the feasibility of laparoscopic neurolysis of the plexus sacralis and the sciatic nerve in deep endometriotic infiltration of the lateral pelvic wall. METHODS: A transperitoneal approach to the pelvic nerves combined with the LANN technique for intraoperative assessment of the function of the exposed nerves permit exposure and sparing of all somatic nerves during resection of the endometriotic lesion. RESULTS: We report on our short experience with 21 patients who underwent this technique for the treatment of endometriotic infiltration of the sacral plexus at different levels. CONCLUSION: In young patients with chronic unilateral sciatica or unilateral pudendal neuralgia - Alcock's canal syndrome - where no neurological/orthopedic etiologies have been found, endometriotic infiltration of the lateral pelvic wall has to be implicated as a potential etiology and an indication for laparoscopy must be discussed. Laparoscopic neurolysis of the pelvic somatic nerves is a feasible procedure for trained laparoscopic surgeons who have a good knowledge of the retroperitoneal pelvic (neuro)anatomy.

Chronic recurrent multifocal osteomyelitis.

The case of a 17-year-old boy with Chronic Recurrent Multifocal Osteomyelitis (CRMO) is presented. Clinical manifestations included a three month history of marked antalgic scoliosis, thoracic and mid-sternal pain, mild fever, elevated erythrocyte sedimentation rate, and skin lesions such as acne and psoriasis. Radiologically, osteolytic lesions were seen in the sternum and the thoracic spine. Histopathological examination of the sternal lesion revealed chronic osteomyelitis. Bone cultures of the resected specimen were negative for known pathogens. The combination of the clinical, radiological, histopathological and microbiological features was the clue to the diagnosis of CRMO.