Protective operative techniques in radical hysterectomy in early cervical carcinoma and their influence on disease-free and overall survival: a systematic review and meta-analysis of risk groups.

PURPOSE: Radical hysterectomy with pelvic lymphadenectomy presents the standard treatment for early cervical cancer. Recently, studies have shown a superior oncological outcome for open versus minimal invasive surgery, however, the reasons remain to be speculated. This meta-analysis evaluates the outcomes of robotic and laparoscopic hysterectomy compared to open hysterectomy. Risk groups including the use of uterine manipulators or colpotomy were created. METHODS: Ovid-Medline and Embase databases were systematically searched in June 2020. No limitation in date of publication or country was made. Subgroup analyses were performed regarding the surgical approach and the endpoints OS and DFS. RESULTS: 30 studies fulfilled the inclusion criteria. Five prospective, randomized-control trials were included. Patients were analyzed concerning the surgical approach [open surgery (AH), laparoscopic surgery (LH), robotic surgery (RH)]. Additionally, three subgroups were created from the LH group: the LH high-risk group (manipulator), intermediate-risk group (no manipulator, intracorporal colpotomy) and LH low-risk group (no manipulator, vaginal colpotomy). Regarding OS, the meta-analysis showed inferiority of LH in total over AH (0.97 [0.96; 0.98]). The OS was significantly higher in LH low risk (0.96 [0.94; 0.98) compared to LH intermediate risk (0.93 [0.91; 0.94]). OS rates were comparable in AH and LH Low-risk group. DFS was higher in the AH group compared to the LH group in general (0.92 [95%-CI 0.88; 0.95] vs. 0.87 [0.82; 0.91]), whereas the application of protective measures (no uterine manipulator in combination with vaginal colpotomy) was associated with increased DFS in laparoscopy (0.91 [0.91; 0.95]). CONCLUSION: DFS and OS in laparoscopy appear to be depending on surgical technique. Protective operating techniques in laparoscopy result in improved minimal invasive survival.

Laparoscopic Colpo-Pneumo Occluder as a Vaginal Mold for Vaginal Reconstruction.

BACKGROUND: Currently, there is no commercially available soft vaginal mold designed for reconstructive surgeries for congenital vaginal anomalies. Stricter operating room regulations discourage the use of makeshift molds from foams and gloves. A colpo-pneumo-occluder balloon is designed to maintain pneumoperitoneum after colpotomy in laparoscopic hysterectomies and is approved for use in vaginal surgeries. CASE: A 17-year-old girl with a congenital transverse vaginal septum experienced recurrent obstruction and hematocolpos. We successfully used a colpo-pneumo-occluder balloon as a vaginal mold during postoperative care. Its size and design make this device ideal for use in vaginal reconstructive surgeries in adolescents. SUMMARY AND CONCLUSION: The laparoscopic colpo-pneumo-occluder, a sterile vaginal device, is appropriate to use as an adjustable, soft vaginal mold for correction of congenital and acquired vaginal anomalies.

Removal of an Abdominal Cerclage by Colpotomy: A Novel and Minimally Invasive Technique.

Abdominal cerclage is an effective treatment for cervical incompetence in patients with a previously failed vaginal cerclage or with anatomic restrictions to a vaginal cerclage. Management of second trimester complications that warrant a delivery impose a complex clinical situation in patients with an abdominal cerclage. We report 3 cases of successful removal of an abdominal cerclage by posterior and anterior colpotomy in the second trimester of pregnancy. This new and minimally invasive surgical technique avoids the need for extensive dilation, laparoscopy, or laparotomy to remove the cerclage and allow a vaginal delivery.

The resurrection of sacrospinous fixation: unilateral apical sling hysteropexy.

INTRODUCTION AND HYPOTHESIS: The apical compartment is a keystone in POP treatment. Sacrospinous fixation, suggested half a century ago, today is still one of the most popular and efficient methods of colpo-hysteropexy. However, it has specific side effects: chronic pain syndrome, dyspareunia and а high rate of cystocele de novo. We aimed to evaluate the efficacy and safety of unilateral sacrospinous hysteropexy with a synthetic apical sling combined with anterior subfascial colporrhaphy. METHODS: Following the suggested technique, 174 women with anterior-apical prolapse underwent surgery. The follow-up period took 12 months. Pre- and postoperative examination included: urogynecological examination (POP-Q), uroflowmetry, ultrasound of the bladder and filling in of validated questionnaires (PFDI-20, PISQ-12). RESULTS: The mean surgery time was 26 ± 7.84 min. No cases of damage of the bladder or rectum or of intraoperative clinically significant bleeding were noted. At the 12-month follow-up, the recurrence rate in the apical compartment was 0.7% (1/147) and in the anterior compartment 7.4% (11/147). The efficacy of the surgery reached 96.5%. During 12 months of follow-up, no cases of mesh exposure or chronic pelvic pain syndrome were detected. The incidence of dyspareunia de novo was observed in just one patient. CONCLUSIONS: A unilateral sacrospinous fixation with a synthetic mesh (apical sling) combined with anterior subfascial colporrhaphy enhances the anatomical efficacy of surgery. It also helps to avoid specific side effects of traditional sacrospinous fixation.

Laparoscopic Radical Hysterectomy with Enclosed Colpotomy and without the Use of Uterine Manipulator for Early-Stage Cervical Cancer.

It was reported recently that minimally invasive radical hysterectomy was associated with worse prognosis than the open abdominal counterpart for the management of early-stage cervical cancer. Uterine manipulator and intracorporeal open colpotomy may be the 2 main suspects responsible for the inferiority. We hypothesize that minimally invasive radical hysterectomy with enclosed colpotomy and without the use of a uterine manipulator will improve survival. Thus, laparoscopic radical hysterectomy with abdominal uterine manipulation and enclosed colpotomy was performed in women with early-stage cervical cancer. The round ligament, the ovary ligament, and the fallopian tube were sutured together for the abdominal manipulation of the uterus. Meanwhile, the upper vagina was ligated before colpotomy to avoid tumor spillage. There were no intraoperative and postoperative complications. The abdominal uterine manipulation and enclosed colpotomy technique, which are both safe and feasible in this study, provide a relatively tumor-free approach for minimally invasive radical hysterectomy. Further investigation of oncologic outcomes in larger prospective studies are needed to confirm our hypothesis.

Ultrasonic versus monopolar energy-based surgical devices in terms of surgical smoke and lateral thermal damage (ULMOST): a randomized controlled trial.

BACKGROUND: The purpose of this study was to compare the degree of surgical smoke or vapor and lateral thermal damage caused by two different energy-based surgical devices (ESDs) used in colpotomy during total laparoscopic hysterectomy. METHODS: Patients undergoing laparoscopic hysterectomy were randomly assigned to an ultrasonic ESD group (n = 20) or monopolar ESD group (n = 20). Colpotomy was performed using the assigned ESD. The degree of surgical smoke or vapor obstructing the laparoscopic view was assessed by two independent reviewers using a 5-point Likert scale, in which a higher score indicates worse visibility. The degree of the lateral thermal damage was measured as the width from the point of instrument application to the margins of the unchanged nearby tissue using a light microscope. RESULTS: The baseline characteristics did not statistically differ between the two groups. The degree of surgical smoke or vapor obstructing vision was 1.2 ± 0.8 points in the ultrasonic group and 3.9 ± 0.7 points in the monopolar groups (p < 0.001). The lateral thermal damage was significantly increased in the monopolar group compared to in the ultrasound group (1500 µm [1200-2500 µm] vs. 950 µm [650-1725 µm], p = 0.037). CONCLUSION: Ultrasonic ESD had better laparoscopic visibility and caused less lateral thermal damage during colpotomy compared to monopolar device.

The McCarus-Volker ForniSee®: A Novel Trans-illuminating Colpotomy Device and Uterine Manipulator for Use in Conventional and Robotic-Assisted Laparoscopic Hysterectomy.

PURPOSE: The purpose of this paper is to introduce a novel trans-illuminating culdotomy and uterine manipulator device. MATERIALS AND METHODS: The study was a prospective, non-randomized, non-blinded observational clinical study involving 50 female patients undergoing total laparoscopic hysterectomy (TLH) or laparoscopic supracervical hysterectomy (LSH) for benign indications. The surgeries were performed from March through May 2012 at two institutions. The primary study objectives were to demonstrate the safety and adequate clinical performance of the uterine manipulator device and to illustrate its potential widespread future use in minimally invasive gynecologic procedures. RESULTS: Average patient age was 45.1 years and, of the 50 patients, 33 had undergone previous intra-abdominal surgery. There were no reports of adverse events, difficulty with placement of the instrument, multiple attempts at placement, or difficulty with uterine manipulation. There was only one device-related uterine perforation, and pneumoperitoneum was maintained in all cases during culdotomy. Vaginal tissue left on subjects was less than 5mm. Overall, there were no ureteral injuries, there were two reported incidental cystotomies, and average blood loss was 99.0cc. Postoperative courses were normal for all patients, with only two reported postoperative complications: a possible vaginal cuff abscess and a 2cm vaginal mucosal cuff separation. CONCLUSIONS: The McCarus-Volker ForniSee® (LSI Solutions, Inc., Victor, New York) is a novel trans-illuminating culdotomy device and uterine manipulator that is safe, efficient, functional, and easy to use. Trans-illumination additionally delineates and enhances identification of critical anatomic planes, such as the vesicovaginal junction and cervicovaginal junction.

Comparing two Uterine Manipulators During Total Laparoscopic Hysterectomy: A Randomized Controlled Trial.

STUDY OBJECTIVE: To compare 2 different types of uterine manipulators (i.e., tight fitting vs loose fitting) used for total laparoscopic hysterectomy (TLH). DESIGN: A randomized controlled trial. The primary end points were time for colpotomy, time from skin incision to detachment of the uterus, and histologic assessment of thermal damage to the vagina (Canadian Task Force classification I). SETTING: A university teaching hospital. PATIENTS: All consecutive women scheduled for TLH from May 2014 to December 2015. Patients were excluded if pregnancy or malignancy was suspected or uterine size exceeded 20 weeks' gestation. INTERVENTIONS: Patients were randomized to undergo TLH with 1 of the following uterine manipulators: (1) Colpo-Probe Vaginal Fornix Delineator (Cooper Surgical, Inc, Trumbull, CT) or (2) Hohl manipulator (KARL STORZ AG, Tuttlingen, Germany). MEASUREMENTS AND MAIN RESULTS: A total of 91 patients, 49 in the Hohl manipulator group and 42 in the Colpo-Probe group, were included in the final analysis. There was no difference in patient characteristics, uterine weight, or estimated blood loss. The median time for insertion of the manipulator (2 minutes [interquartile range (IQR), 2-5 minutes] vs 6 minutes [IQR, 5-7], p < .001), the median time from skin incision to detachment of the uterus (55 minutes [IQR, 41-70] vs 65 minutes [IQR, 58-79], p = .004), and the median time for colpotomy (7 minutes [IQR, 5-10] vs 12 [IQR, 8-17], p < .001) were shorter with the Hohl manipulator. Thermal damage to the vagina varied greatly and ranged from 32 µm to 5232 µm but was not significantly different between groups (median maximum thermal damage = 1043 µm [IQR, 682-1934] vs 1522 µm [IQR, 884-2144], p = .211). CONCLUSION: Use of the Hohl manipulator results in a shorter operative time from skin incision to detachment of the uterus during TLH. Although the colpotomy time is shorter using the Hohl manipulator, this did not translate to less thermal damage to the vaginal cuff. Further studies comparing uterine manipulators are warranted to find the optimal instrument for ease of surgery and decreased thermal spread.

Transvaginal PVDF-mesh for cystocele repair: A cohort study.

INTRODUCTION: Optimized biocompatibility of new materials is a major requirement for transvaginal meshes for pelvic organ prolapse (POP) repair. Polyvinylidene fluoride (PVDF) presented good characteristics in prior animal experiments and clinical use in humans. METHODS: Between 01/2012 and 04/2016 37 women underwent transvaginal repair of symptomatic prolapse of the anterior vaginal wall (cystocele) with PVDF-mesh in a single institution. A chart review for recurrence, continence, peri- and early postoperative complications was performed. Referring practitioners were interviewed by telephone and mail. Additionally patient reported outcome and satisfaction were measured by Patient Global Improvement Inventory (PGI-I) scale. RESULTS: 34 women were eligible for a mean follow up of 19 months. The functional outcome improved significantly. One symptomatic vault prolapse (2.9%) and two reoperations for incontinence (5.9%) occurred. Two mesh exposures (5.9%) occurred and were treated conservatively. No other severe complications were registered. 87.5% of treated women felt very much better or much better and would undergo the surgery again. A cohort study including development steps in accordance with the IDEAL system is presented. CONCLUSIONS: For the first time we report on effectivity and safety of transvaginal application of PVDF-mesh in real-life practice. A prospective long-term evaluation in a registry is justified.

Rectovaginal fistula caused by retained colpotomy cup after surgery.

Colpotomizer instruments are commonly used in laparoscopic hysterectomy to easily manipulate the uterus. This is the case of a forgotten colpotomy cup retained in the vagina for five years, which led to a rectovaginal fistula. A 54-year-old woman without knowledge of presence of the foreign body visited with chronic abdominal pain and foul odorous discharge. Rectovaginal fistula caused by the retained forgotten colpotomy cup was found upon examination.

Hand-assisted laparoscopic ovariectomy and colpotomy in standing mares.

OBJECTIVE: To determine the feasibility of hand-assisted laparoscopic ovariectomy via colpotomy for bilateral ovariectomy in standing mares. STUDY DESIGN: Case series. ANIMALS: Mares (n = 21) aged 2-21 years, weighing 312-582 kg. METHODS: After a pilot study in 6 mares, the technique was used in 15 mares. Ovaries were identified and manipulated using 2 laparoscopic portals in the left paralumbar fossa. Transection and hemostasis of the ovarian pedicle was achieved using a LigaSure Atlas™ or chain écraseur. Ovaries were removed through a colpotomy by an assistant. RESULTS: In 19 mares, both ovaries were successfully identified from the left portals whereas in 2 mares, laparoscopic portals in the right flank were needed to access the right ovary because the working length of the equipment was insufficient to reach the right side from the left portals. CONCLUSIONS: Bilateral laparoscopic ovariectomy by means of 2 same-sided portals in combination with hand assistance via colpotomy is a technically feasible, safe, and effective technique in small- to average-sized mares.

Optimization strategies for colpotomizer technology during total laparoscopic hysterectomy.

As technology has evolved, so has the ability to perform a hysterectomy in a minimallly invasive fashion. Currently, total laparoscopic hysterectomy has been further advanced with the advent of uterine manipulation devices that incorporate the use of a cupped colpotomizer. Unfortunately, many gynecologic surgeons lack the understanding of how to fully utilize such a surgical guide to facilitate development of the vesico-uterine reflection, skeletonize uterine vasculature, gain entry into the vagina, and subsequently close the vaginal cuff. Safe completion of these steps has the potential to minimize complications such as ureteral and bladder injury in addition to vaginal cuff dehiscence. The following technical review will address methods for the safe and effective use of various cupped colpotomizer devices during total laparoscopic hysterectomy.

A modified technique to simplify TLH with new developed uterine manipulator; Anurach uterine manipulator (AUM).

OBJECTIVE: Total Laparoscopic hysterectomy (TLH) has became more commonly procedures for gynaecological surgery, but high incidence of complications and the technical challenges are still problematic among less-experienced surgeons. To accomplish these difficulties, we developed the new uterine manipulator; Anurach uterine manipulator (AUM) to simplify TLH with the modified technique. Our objective was to evaluate the feasibility of the new uterine manipulator; AUM, with the modified total laparoscopic hysterectomy in an initial cohort of patients. MATERIAL AND METHOD: From October 2007 though September 2008, one hundred cases of hysterectomy were done by modified technique of TLH using A UM. After installation of AUM, a modified technique of TLH was started by posterior colpotomy, then extended to anterior colpotomy. The operation was performed using bipolar and harmonic scapel for coagulation and cutting the vascular pedicles and ligaments. The entire procedure was done laparoscopically and the uterus was removed vaginally. The vaginal cuff was closed by continuous suture, double layers with PDS material. RESULTS: Most common indication was symptomatic leiomyoma, the uterine size was 64-620 grams. Mean operation time was 98 +/- 27.1 minutes. Estimated blood loss was 188 +/- 87.5 ml. There were no bowel or ureteric injuries, except 2 cases of bladder injury which had been repaired laparoscopically. CONCLUSION: The modified technique using AUM could be the option to simplify TLH, in reducing the complications and having more favorable operative outcomes.

[Vaginal pelvic repair. Always with mesh or not?]. / Vaginaler Beckenbodenrepair. Immer mit Netz?

Several surgical methods are possible when aiming at reconstruction of pelvic organ prolapse in women, and the experienced surgeon implements the knowledge gained from open, laparoscopic, and vaginal techniques. These feature different rates of success and relapse as well as different complication risks. Because of the accumulating morbidity of aging patients, there is a search for a safe minimally invasive technique. With the advent of synthetic meshes, surgeons have used them frequently and often uncritically for reconstruction of the female pelvic floor. In these cases the vaginal approach is preferred as opposed to alternative techniques, as it is less invasive and allows for better convalescence. Furthermore, this approach leads to low complication and relapse rates even when synthetic meshes are omitted.

Trocar-guided total tension-free vaginal mesh repair of post-hysterectomy vaginal vault prolapse.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to report 1 year anatomical and functional outcomes of trocar-guided total tension-free vaginal mesh (Prolift) repair for post-hysterectomy vaginal vault prolapse with one continuous piece of polypropylene mesh. METHODS: We conducted a prospective observational cohort study of 46 patients. A minimum sample size of 35 patients was needed to detect a recurrence rate of less than 20% at 12 months. Instruments of measurement used were pelvic organ prolapse quantification and validated questionnaires. RESULTS: Overall anatomical success was 91% (95% confidence interval 83-99), with significant improvement in experienced bother and quality of life. Mesh exposure occurred in seven patients (15%). No adverse effects on sexual function could be detected. CONCLUSIONS: Trocar-guided total tension-free vaginal mesh (Prolift) repair with one continuous piece of mesh for post-hysterectomy vaginal vault prolapse is well tolerated and anatomically and functionally highly effective. Results of controlled trials will determine its position in the operative armamentarium.

Multimedia manuscript. NOTES retroperitoneal transvaginal distal pancreatectomy.

BACKGROUND: The retroperitoneal approach preserves the peritoneal cavity and its envelope. The benefits of laparoscopic retroperitoneal approach to the kidney and the adrenal gland are well known. The pancreas may represent another potential target. Whereas NOTES transperitoneal distal pancreatectomy has been reported, the retroperitoneal approach, which may combine the advantages of peritoneal preservation with those of no scar surgery, has never been explored. We report the feasibility of NOTES transvaginal retroperitoneal pancreatectomy in a porcine model. METHODS: With the pig supine, under general anesthesia, a 10-mm posterior colpotomy was performed with a needle-knife operated through a flexible 12-mm, double-channel endoscope (Karl Storz). A retroperitoneal tunnel was created with blunt dissection up to the left kidney with progressive visualization of the left iliac vessels, ureter, and abdominal aorta. To reach the posterior aspect of the pancreas, a space was opened medial to the upper renal pole dividing the Gerota's fascia. The tail of pancreas was mobilized with blunt and sharp dissection, using monopolar cautery. Once the distal pancreas was dissected free, it was secured using a polypropylene endoscopic loop and then resected with an endoscopic snare (Olympus). RESULTS: The procedure was successfully accomplished by a totally NOTES approach in five pigs, with a mean operative time of 118 (range, 105-185) minutes with no intraoperative complications and no injury to any retroperitoneal structure. CONCLUSIONS: The pancreas is accessible by a transvaginal retroperitoneal NOTES approach. Human cadavers studies are necessary to confirm the validity of this model and to explore the need for specific technological developments, such as flexible stapling devices, to improve the safety of pancreatic resection.

Novel technologies for natural orifice surgery: an overview.

Natural Orifice Surgery (NOS) is now being elaborated with the aim to make abdominal surgery simpler and safer. The existing natural openings of the body are used for introduction of surgical instruments and thus to perform surgical procedures while avoiding to penetrate the abdominal wall. Actually, the transvaginal and transgastric approaches are the common routes used for NOS applications in humans. The transvaginal approach does not necessitate any sophisticated devices for opening and closure of the posterior colpotomy, thus being easy for the surgeon and safe for the patient. In contrast, the problem of transluminal access and closure represents significant obstacles in the transgastric approach and is still unsolved. In order to achieve this goal, various surgical prototype devices have been developed. This article aims to give an overview on the current status of techniques and technologies that are being developed and applied in conjunction with NOS procedures.

Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial.

OBJECTIVE: To compare anterior colporrhaphy with and without a tailored mesh. METHODS: Postmenopausal women with anterior vaginal prolapse to the hymen or beyond were randomly assigned to undergo traditional anterior colporrhaphy alone or reinforced with mesh. The low-weight monofilament polypropylene mesh was self-tailored, having four arms and being placed over the plicated fascia. Before and 2 and 12 months after surgery, participants were evaluated by physical examination, postvoidal residual urine measurement and standard questions covering prolapse-related symptoms. The primary outcome was recurrence of anterior vaginal prolapse at 12 months. Secondary outcomes included operative complications, symptom resolution, and postvoidal urine residual volume. RESULTS: Of the 202 women randomly assigned, 201 were operated on (97 without, 104 with mesh). Thirty-seven women (38.5%) in the no-mesh and seven (6.7%) in the mesh group experienced a recurrence of anterior wall prolapse (P<.001) at 12 months; as a result, the number needed to treat for benefit was four. The mean (standard deviation) postvoidal residual urine volume was lower in patients with mesh than in those undergoing the traditional operation: 25 (26) mL and 41 (57) mL (P=.01). Twenty-three women (23%) with mesh and 9 (10%) with no mesh reported stress urinary incontinence (P=.02). In 18 (17.3%), exposure of the mesh was noted, mainly asymptomatic. CONCLUSION: Anterior colporrhaphy, reinforced with, tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation, but was associated more often with stress urinary incontinence.

Retroperitoneal hemorrhage after a vaginal mesh prolapse procedure.

BACKGROUND: The present study describes a complication of a transvaginal pelvic floor repair system for the treatment of anterior vaginal prolapse. CASE: A postmenopausal woman with anterior vaginal wall prolapse was treated with a transvaginal nonabsorbable polypropylene mesh system. The procedure was complicated by a large perioperative retroperitoneal hematoma. CONCLUSION: The insertion of synthetic meshes in gynecologic surgery is gaining popularity, but all pelvic surgeons should be aware of the potential complications associated with these new techniques.