Complication Rate of Laparoscopic Hysterectomies in Denmark, 2011-2016.

BACKGROUND AND OBJECTIVES: After the U. S. Food and Drug Administration's recommendation against the use of power morcellation for tissue extraction in minimally invasive hysterectomy, the number of procedures completed laparoscopically declined in favor of open surgery laparotomy. We conducted a retrospective cohort study comparing perioperative and long-term outcomes, including complications associated with laparoscopic hysterectomy before and after the FDA recommendation. METHODS: We included procedures performed in Danish government hospitals (GHs) and a hospital specializing in minimally invasive gynecological surgery (MIGS). Different types of hysterectomy over the period from January 2011 through May 2016 were examined. RESULTS: Hysterectomies were analyzed from GHs (n = 21,495) and from a hospital specializing in MIGS (n = 749). In the GHs, we found a decrease in open hysterectomy from 40% in 2011 to 20% in 2016. In the MIGS hospital, 4 of 749 (0.05%) open hysterectomies were performed during the 6 years; however, there was a change in operative technique. After the FDA recommendation, there was a shift from laparoscopic subtotal hysterectomy (LSH) to total laparoscopic hysterectomy (TLH) from 32% in 2011 to 82% by May 2016. Containment bags were used in LSH and large-uterus TLH after the 2014 advisory. Significantly more complications occurred in the GHs than in the MIGS hospital: 3224/21,495 (15%) vs 53/749 (7.0%), respectively. CONCLUSION: The rate of minimally invasive hysterectomies continues to increase. However, after 2014, many of the morcellation techniques have been replaced by a minilaparotomy to extract the uterus at the end of surgery, compared to the use of the contained morcellation in 100% of cases in the MIGS hospital. There was a major difference in complication rates between the hospitals that is partly explainable by the challenge in training residents and the low operative volume of surgeons in GHs.

Deep neuromuscular blockade and low insufflation pressure during laparoscopic hysterectomy.

INTRODUCTION: Establishment of sufficient muscle relaxation is essential in laparoscopic surgery. During laparoscopy, surgeons can experience abdominal contractions in their patients. Deep neuromuscular block (NMB) has the potential to prevent such episodes. In this study, we explored if deep NMB reduces the incidence of sudden abdominal contractions as compared with standard NMB. METHODS: This was a pre-planned secondary analysis of a randomized, controlled study. A total of 110 patients scheduled for laparoscopic hysterectomy were randomized to either deep NMB and 8 mmHg pneumoperitoneum (deep NMB group) or single-bolus NMB and 12 mmHg pneumoperitoneum (standard NMB group). NMB was established with rocuronium and reversed with sugammadex. Two gynaecologists registered episodes of sudden abdominal contractions, alarms from the insufflator due to increased intraabdominal pressure and incidences with tightness of the abdominal wall. RESULTS: No sudden abdominal contractions were detected in the deep NMB group as compared with 12 episodes in the standard NMB group (p < 0.001). The insufflator alarmed in no versus ten procedures (p = 0.001) in the deep and standard NMB group, respectively. The gynaecologists registered increasing abdominal tensions in no versus eight procedures (p = 0.006) in the deep and standard NMB group, respectively. CONCLUSION: Deep NMB in combination with 8 mmHg pneumoperitoneum prevented sudden abdominal contractions during laparoscopic hysterectomy. FUNDING: This work was funded in part by a research grant from the Investigator Initiated Studies Program of Merck Sharp & Dohme Corp, USA. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp. TRIAL REGISTRATION: The study was assigned with EudraCT number 2012-003787-51 and registered with clinicaltrials.gov (NCT01722097).

Unexpected Uterine Leiomyosarcoma During Laparoscopic Hysterectomy Treated 6 Months With Ulipristal Acetate and Contained Power Morcellation.

DESIGN: A 45-year-old woman with a symptomatic uterine myoma suffering from heavy menstrual bleeding, incontinence, and pain pressure received ulipristal acetate (UPA [Esmya; Gideon Richter, Budapest, Hungary]) for 6 months. SETTING: A Minimal Invasive Gynecology surgery Unit in Chopenhagen Denmark. INTERVENTION: Her symptoms were reduced; however, after 3 months on UPA, she was then admitted because of increased pain. A high level of C-reactive protein was found, and necrosis of the myoma was assumed to be the reason. In December 2015, she opted for a laparoscopic hysterectomy because of the increasing symptoms and lack of conviction that the medical therapy would be sufficient. MEASUREMENTS AND MAIN RESULTS: Ultrasound showed a 106 × 73 mm myoma with no abnormal blood flow or lacuna of fluid inside the myoma; there was no suspicion of malignancies. The video and the report have been approved by the local institutional review board. The weight of the contained morcellated uterus was 575 g, and pathology showed a malignant leiomyoma sarcoma. A postoperative positron emission tomographic scan showed 4 metastatic processes in the lungs. CONCLUSIONS: The Food and Drug Administration has approved the PneumoLiner (Advanced Surgical Concepts, Dublin, Ireland); however, they also stress the point that the device "has not been proven to reduce the risk of spreading cancer." In this case, the UPA treatment actually led to a delay in the diagnosis, potentially with a larger or even metastatic tumor as a consequence.

Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial.

BACKGROUND: Postoperative shoulder pain remains a significant problem after laparoscopy. Pneumoperitoneum with insufflation of carbon dioxide (CO2) is thought to be the most important cause. Reduction of pneumoperitoneum pressure may, however, compromise surgical visualisation. Recent studies indicate that the use of deep neuromuscular blockade (NMB) improves surgical conditions during a low-pressure pneumoperitoneum (8 mmHg). OBJECTIVE: The aim of this study was to investigate whether low-pressure pneumoperitoneum (8 mmHg) and deep NMB (posttetanic count 0 to 1) compared with standard-pressure pneumoperitoneum (12 mmHg) and moderate NMB (single bolus of rocuronium 0.3 mg kg with spontaneous recovery) would reduce the incidence of shoulder pain and improve recovery after laparoscopic hysterectomy. DESIGN: A randomised, controlled, double-blinded study. SETTING: Private hospital in Denmark. PARTICIPANTS: Ninety-nine patients. INTERVENTIONS: Randomisation to either deep NMB and 8 mmHg pneumoperitoneum (Group 8-Deep) or moderate NMB and 12 mmHg pneumoperitoneum (Group 12-Mod). Pain was assessed on a visual analogue scale (VAS) for 14 postoperative days. MAIN OUTCOME MEASURES: The primary endpoint was the incidence of shoulder pain during 14 postoperative days. Secondary endpoints included area under curve VAS scores for shoulder, abdominal, incisional and overall pain during 4 and 14 postoperative days; opioid consumption; incidence of nausea and vomiting; antiemetic consumption; time to recovery of activities of daily living; length of hospital stay; and duration of surgery. RESULTS: Shoulder pain occurred in 14 of 49 patients (28.6%) in Group 8-Deep compared with 30 of 50 (60%) patients in Group 12-Mod. Absolute risk reduction was 0.31 (95% confidence interval 0.12 to 0.48; P = 0.002). There were no differences in any secondary endpoints including area under the curve for VAS scores. CONCLUSION: Deep NMB and low-pressure pneumoperitoneum (8 mmHg) reduced the incidence of shoulder pain after laparoscopic hysterectomy in comparison to moderate NMB and standard-pressure pneumoperitoneum (12 mmHg). TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01722097.

Placenta accreta: adherent placenta due to Asherman syndrome.

It is important to be aware of the risk of abnormally invasive placenta in patients with a history of Asherman syndrome and uterine scarring. A prenatal diagnosis by ultrasonography is useful when planning of mode of delivery.

Deep neuromuscular blockade leads to a larger intraabdominal volume during laparoscopy.

Shoulder pain is a commonly reported symptom following laparoscopic procedures such as myomectomy or hysterectomy, and recent studies have shown that lowering the insufflation pressure during surgery may reduce the risk of post-operative pain. In this pilot study, a method is presented for measuring the intra-abdominal space available to the surgeon during laproscopy, in order to examine whether the relaxation produced by deep neuromuscular blockade can increase the working surgical space sufficiently to permit a reduction in the CO2 insufflation pressure. Using the laproscopic grasper, the distance from the promontory to the skin is measured at two different insufflation pressures: 8 mm Hg and 12 mm Hg. After the initial measurements, a neuromuscular blocking agent (rocuronium) is administered to the patient and the intra-abdominal volume is measured again. Pilot data collected from 15 patients shows that the intra-abdominal space at 8 mm Hg with blockade is comparable to the intra-abdominal space measured at 12 mm Hg without blockade. The impact of neuromuscular blockade was not correlated with patient height, weight, BMI, and age. Thus, using neuromuscular blockade to maintain a steady volume while reducing insufflation pressure may produce improved patient outcomes.

AAGL Practice Report: Practice Guidelines for the Management of Hysteroscopic Distending Media: (Replaces Hysteroscopic Fluid Monitoring Guidelines. J Am Assoc Gynecol Laparosc. 2000;7:167-168.).

The objective of this guideline is to provide clinicians with evidence-based information about commonly used and available hysteroscopic distending media to guide them in their performance of both diagnostic and operative hysteroscopy. While necessary for the performance of hysteroscopy and hysteroscopically-directed procedures, distending media, if absorbed systemically in sufficient amounts, can have associated adverse events, including life-threatening complications. Consequently, understanding the physical properties and the potential risks associated with the use of the various distending media is critical for the safe performance of hysteroscopic procedures. This report was developed under the direction of the Practice Committee of the AAGL as a service to their members and other practicing clinicians.

Single port laparoscopic surgery: concept and controversies of a new technique.

LESS, or laparo-endoscopic single site surgery, is a promising new method in minimally invasive surgery. An increasing number of surgical procedures are being performed using this technique; however, its large-scale adoption awaits results of prospective randomized controlled studies confirming potential benefits. Theoretically, cosmetic outcomes, postoperative pain and complication rates could be improved with use of single site surgery. This study describes introduction of the method in a private hospital in Denmark in which 40 women were treated for benign gynecologic conditions. Although the operations described are the first of their kind reported in Denmark, favorable operating times and very low complication rates are seen. It is the authors' opinion that in addition to being feasible for hysterectomy, single port laparoscopy may become the preferred method for many simple gynecological procedures.

Small bowel obstruction associated with use of a gelatin-thrombin matrix sealant (FloSeal) after laparoscopic gynecologic surgery.

We report 2 cases of laparoscopic gynecologic procedures, complicated by small bowel obstruction possibly related to use of a hemostatic agent. The cause was most likely from excess material not incorporated in the hemostatic clot at the site of application. Gentle irrigation and removal of excess material from the site of application is recommended by the manufacturer of FloSeal and may reduce the risk of postoperative adhesion formation and small bowel obstruction.

Risk factors for uterine rupture after laparoscopic myomectomy.

Case reports for uterine rupture subsequent to laparoscopic myomectomy were reviewed to determine whether common causal factors could be identified. Published cases were identified via electronic searches of PubMed, Google Scholar, and hand searches of references, and unpublished cases were obtained via E-mail queries to the AAGL membership and AAGL Listserve participants. Nineteen cases of uterine rupture after laparoscopic myomectomy were identified. The removed myomas ranged in size from 1 through 11 cm (mean, 4.5 cm). Only 3 cases involved multilayered closure of uterine defects. Electrosurgery was used for hemostasis in all but 2 cases. No plausible contributing factor could be found in one case [corrected]. It seems reasonable for surgeons to adhere to techniques developed for abdominal myomectomy including limited use of electrosurgery and multilayered closure of the myometrium. Nevertheless, individual wound healing characteristics may predispose to uterine rupture.

Treatment of endometrial polyps: a systematic review.

BACKGROUND: Transcervical resection of endometrial polyps is usually performed in order to exclude atypic and/or malignant endometrial changes, to relieve abnormal uterine bleeding or to improve infertility. OBJECTIVE: To systematically explore the rationale of transcervical polyp resection. SEARCH STRATEGY: Electronic searches of MEDLINE, EMBASE and The Cochrane Library. SELECTION CRITERIA: Studies reporting the prevalence of premalignant and/or malignant tissue changes within endometrial polyps, as well as outcomes of endometrial polyp removal in terms of symptom relief and improved fertility were included. MAIN RESULTS: 46 studies met the criteria for inclusion (malignancy: 20 studies including 9,266 women, symptom relief: 15 studies including 1,034 women, infertility: 11 studies including 935 women). Most studies were uncontrolled retrospective case series. Only two randomized controlled trials were identified. The prevalence of premalignant and malignant tissue changes within endometrial polyps varied in the included studies, 0.2-23.8% and 0-12.9%, respectively. Postmenopausal symptomatic women appeared to have the highest risk of premalignant and malignant tissue changes. The effect of polypectomy on periodic blood loss appeared to be questionable, but all studies measuring the effect of polypectomy by general terms such as improved/not improved reported a favorable outcome (75-100% success rate). Polypectomy appears to have a favorable outcome in infertile women. CONCLUSIONS: The evidence which substantiates the removal of endometrial polyps is limited, and future research evaluating the outcome of this common procedure is required. Based on the available evidence, however, we provide recommendations for treatment of women with endometrial polyps.

Clinical effectiveness of transcervical polyp resection in women with endometrial polyps: randomized controlled trial.

STUDY OBJECTIVE: To estimate the clinical effectiveness of transcervical resection of endometrial polyps. DESIGN: Randomized controlled trial (Canadian Task Force classification I). SETTING: University teaching hospital. PATIENTS: One hundred fifty premenopausal women with endometrial polyps. INTERVENTIONS: Either transcervical resection of the polyp or observation for 6 months. MEASUREMENTS AND MAIN RESULTS: There was no difference in periodic blood loss measured using the Pictorial Blood Assessment Chart between the study groups at 6-month follow-up. A significant difference between the groups was observed in favor of the intervention group for 2 secondary outcome measures: mean difference of periodic blood loss measured using a visual analog scale (score, 0.7; 95% confidence interval, 0.11-1.30; p = .02) and occurrence of gynecologic symptoms at follow-up (7 of 75 patients [9.3%] vs 28 of 75 [37.3%]; p <.001). Data were analyzed according to the principle of intention to treat. CONCLUSION: Transcervical resection of endometrial polyps seems to have minimal effect on periodic blood loss; however, the procedure seems to relieve symptoms such as intermenstrual bleeding in most premenopausal women.

WITHDRAWN: Uterine malformation: diagnosis and results after hysteroscopic metroplasty.

This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.

Abdominal access in gynaecological laparoscopy: a comparison between direct optical and blind closed access by Verres needle.

OBJECTIVE: Complications associated with initial abdominal entry are a prime concern for laparoscopic surgeons. In order to minimize first access-related complications in laparoscopy, several techniques and technologies have been introduced in the past years. This investigation compares two laparoscopic access techniques. STUDY DESIGN: 194 women underwent laparoscopic surgery for simple ovarian cysts: 93 were assigned to direct optical access (DOA) abdominal entry (group I), and 101 women to classical closed method by Verres needle, pneumoperitoneum and trocar entry (group II). The following parameters were compared: time required for entry into abdomen, occurrence of vascular and/or bowel injury, blood loss. The results were analyzed using SAS software. p-value<0.05 was considered as significant. RESULTS: No statistically significant differences were observed in the occurrence of blood loss and minor vascular injury between the two techniques, as well as minor bowel injuries; time for of abdominal entry, instead, were significantly reduced in the DOA group. CONCLUSIONS: The results of the preliminary comparison between the DOA and the Verres methods, commonly used by gynecologists, suggests that the visual entry system confers a statistical advantage over closed entry technique with Verres needle, in terms of time saving and due to the minor vascular and bowel injuries, thus enabling a safe and expeditious, visually-guided, entry for surgeons.

Uterine artery embolization versus laparoscopic occlusion of uterine arteries for leiomyomas: long-term results of a randomized comparative trial.

PURPOSE: To compare long-term symptom recurrence and 6-month magnetic resonance (MR) imaging results after two different treatments for uterine leiomyomas. MATERIALS AND METHODS: Sixty-six women with uterine leiomyomas were randomized to undergo uterine artery embolization (UAE) or laparoscopic bilateral occlusion of uterine arteries. Contrast-enhanced MR imaging was performed before treatment and after 6 months. RESULTS: Fifty-eight patients received treatment. Median follow-up time was 48 months (range, 8-73 months). Clinical failure and symptom recurrence occurred in 14 patients after laparoscopy (48%) and in five after UAE (17%; P = .02, log-rank test). Hysterectomy was performed in two patients after UAE (7%) and in eight after laparoscopy (28%; P = .041). Six-month MR imaging results were available for 26 patients treated with UAE and 22 treated with laparoscopy. The mean uterine volume was reduced by 51% (range, 16%-86%) after UAE treatment, compared with 33% (range, 6%-77%) after laparoscopy (P = .001). Complete leiomyoma infarction was seen in all 26 patients in the UAE group and in only five patients in the laparoscopy group (P < .001). Eleven patients experienced symptom recurrence later than 6 months. Uterine volume reduction at 6 months was 24% in this group, compared with 48% in the 37 patients with no recurrence (P = .004). Incomplete infarction of leiomyomas was seen in eight of the 11 cases of recurrence (73%) versus nine of 37 cases without recurrence (24%; P = .009). CONCLUSIONS: Recurrence rate was significantly lower after UAE than after laparoscopic treatment. Larger volume reduction and more complete devascularization of leiomyomas were found after UAE treatment and among patients with no recurrence.