Evelien M. Sandberg

Barbed Versus Standard Suture: A Randomized Trial for Laparoscopic Vaginal Cuff Closure

STUDY OBJECTIVE To compare closure times, cuff healing, and postoperative dyspareunia between barbed and traditional sutures during laparoscopic total hysterectomy. DESIGN A randomized clinical trial (Canadian Task Force classification I). SETTING A university hospital. PATIENTS Sixty-three women undergoing total laparoscopic hysterectomy. INTERVENTIONS Total laparoscopic hysterectomy was performed using standard techniques. The vaginal cuff closure method was randomized to barbed suture (Quill; Angiotech Pharmaceuticals, Inc., Vancouver, Canada) or standard suture (Vicryl; Ethicon Inc., Somerville, NJ). The time required for cuff closure was documented. Patients were examined postoperatively to assess cuff healing, and a standardized sexual function questionnaire was administered preoperatively and at 3 months postoperatively. MEASUREMENTS AND MAIN RESULTS The mean vaginal cuff closure time was 10.4 minutes versus 9.6 minutes in the barbed versus standard suture group (p = .51). Cuff healing appeared similar between the 2 groups. Rates of dyspareunia, partner dyspareunia, and sexual function were similar in both groups at 3 months postoperatively. Vaginal cuff closure times were significantly faster among attendings compared with residents/fellows (7.1 vs. 12.8 minutes, respectively; p < .0001). The study was designed to have a statistical power of 80% to detect a difference of 5 minutes in cuff closure time between the 2 groups (α level of 0.05). CONCLUSION Laparoscopic vaginal cuff closure times are similar when using barbed sutures and braided sutures.

Utility of Cystoscopy During Hysterectomy

OBJECTIVE: To estimate the incidence of cystoscopy use at time of hysterectomy and its use to detect urinary tract injury. METHODS: This was a retrospective cohort study in a tertiary care academic center of 1982 patients who underwent a hysterectomy for any indication (excluding obstetric) between January 2009 and December 2010. Medical records were reviewed for baseline and perioperative characteristics, cystoscopy use, and information about bladder or ureteral injury related to hysterectomy. RESULTS: Two hundred fifty-one women (12.66%, 95% confidence interval [CI] 11.23–14.21%) underwent a cystoscopy at the time of hysterectomy with no reported complications resulting from the cystoscopy procedure. Cystoscopy was most frequently used by low-volume surgeons and in cases involving prolapse or vaginal mode of access. Fourteen patients (0.71%, 95% CI 0.39–1.19%) experienced bladder injury and five patients (0.25%, 95% CI 0.08–0.58%) sustained ureteral injury. None of these complications were detected by cystoscopy; cystoscopy was either normal at the time of hysterectomy or was omitted. The presence of adhesions was significantly associated with bladder injury at the time of hysterectomy (P=.006). Low-volume surgeon and laparoscopic or robotic mode of access were both significantly associated with ureteral injury (P=.023 and P=.042, respectively). CONCLUSIONS: Our data support selective rather than universal cystoscopy at the time of hysterectomy. LEVEL OF EVIDENCE: II

Barbed compared with standard suture: Effects on cellular composition and proliferation of the healing wound in the ovine uterus

Objective. To compare cellular composition (fibroblasts vs. smooth muscle cells) and proliferation in uterine healing wounds after application of barbed compared with standard suture in a sheep model. Design. Randomized trial (Canadian Task Force classification I) using each animal as its own control. Setting. Certified animal research facility. Population or sample. 23 non‐pregnant ewes. Methods. A myometrial incision was created with the harmonic scalpel in each horn of the bicornuate uterus. The incisions were randomly allocated to be closed using either polyglactin 210 (Vicryl®) or barbed suture. Three months later, uterine tissues were collected, fixed and used for determination of cellular composition and proliferation using histochemistry (Masson trichrome staining) and immunohistochemistry (staining of smooth muscle cell actin and Ki67, a marker of proliferating cells) followed by image analysis. Main outcome measures. Evaluation and comparison of the cellular composition and proliferation of uterine wounds after application of barbed vs. standard suture. Results. The ratio between connective tissue elements and smooth muscle cells, expression of smooth muscle cell actin and labeling index were similar in wounds after application of barbed compared with standard suture, but were different (p < 0.0001–0.05) in wounds than in non‐wounded areas in uterus. Conclusion. Both barbed and standard sutures had similar effects on cellular composition and proliferation of uterine wounds in an animal model.

Case-Mix Variables and Predictors for Outcomes of Laparoscopic Hysterectomy: A Systematic Review

The assessment of surgical quality is complex, and an adequate case-mix correction is missing in currently applied quality indicators. The purpose of this study is to give an overview of all studies mentioning statistically significant associations between patient characteristics and surgical outcomes for laparoscopic hysterectomy (LH). Additionally, we identified a set of potential case-mix characteristics for LH. This systematic review was conducted according to the Meta-Analysis of Observational Studies in Epidemiology guidelines. We searched PubMed and EMBASE from January 1, 2000 to August 1, 2015. All articles describing statistically significant associations between patient characteristics and adverse outcomes of LH for benign indications were included. Primary outcomes were blood loss, operative time, conversion, and complications. The methodologic quality of the included studies was assessed using the Newcastle-Ottawa Quality Assessment Scale. The included articles were summed per predictor and surgical outcome. Three sets of case-mix characteristics were determined, stratified by different levels of evidence. Eighty-five of 1549 identified studies were considered eligible. Uterine weight and body mass index (BMI) were the most mentioned predictors (described, respectively, 83 and 45 times) in high quality studies. For longer operative time and higher blood loss, uterine weight ≥ 250 to 300 g and ≥500 g and BMI ≥ 30 kg/m(2) dominated as predictors. Previous operations, adhesions, and higher age were also considered as predictors for longer operative time. For complications and conversions, the patient characteristics varied widely, and uterine weight, BMI, previous operations, adhesions, and age predominated. Studies of high methodologic quality indicated uterine weight and BMI as relevant case-mix characteristics for all surgical outcomes. For future development of quality indicators of LH and to compare surgical outcomes adequately, a case-mix correction is suggested for at least uterine weight and BMI. A potential case-mix correction for adhesions and previous operations can be considered. For both surgeons and patients it is valuable to be aware of potential factors predicting adverse outcomes and to anticipate this. Finally, to benchmark clinical outcomes at an international level, it is of the utmost importance to introduce uniform outcome definitions.

Analysis of Risk Factors for Intraoperative Conversion of Laparoscopic Myomectomy.

OBJECTIVES To report the surgical outcomes of laparoscopic myomectomy (LM) and abdominal myomectomy (AM) at a high-volume tertiary care hospital, to evaluate the risk of conversion during LM, and to analyze the associated risk factors. DESIGN Retrospective cohort study (Canadian Task Force classification II). PATIENTS All patients who underwent LM and AM in a tertiary academic center in Boston, Massachusetts between 2009 and 2012. INTERVENTION Medical records were reviewed for baseline characteristics and perioperative outcomes. Robot-assisted laparoscopy was considered a subtype of LM. RESULTS A total of 966 patients underwent myomectomy during the study period, including 731 LM cases (75.67%) and 235 AM cases (24.33%). Compared with patients undergoing LM, those undergoing AM had more myomas removed and heavier specimens (mean number of myomas, 12.60 vs 3.54, p ≤ .001; mean weight, 592.75 g vs 263.4 g, p ≤ .001). Conversion was necessary in 8 LM cases (1.09%). All conversions were reactive in nature and were associated with greater blood loss (mean, 1381.25 vs 167.95 mL; p ≤ .001) and longer hospital stay (mean, 3.13 vs 0.55 days; p ≤ .001) compared with cases without conversion. Factors associated with conversion included both the number and the weight of myomas removed (mean number, 9.75 vs 3.48, p = .003; mean weight, 667.9 vs 259.25 g, p = .015), especially with myomas weighing >500 g (odds ratio = 8.551; p = .005). CONCLUSION The risk of conversion for LM was low (1.09%) in this cohort, and was associated both with the number and the weight of myomas removed. LM is a feasible approach for surgical management of myomas in the majority of cases; however, when myomas are expected to weigh >500 g, it may be prudent to consider referring those cases to specialized centers with highly experienced teams.

Venous thromboembolism prophylaxis for laparoscopic surgery: a survey of members of the Society of Gynecologic Oncology.

Objective This study aimed to evaluate the use of venous thromboembolism (VTE) prophylaxis for laparoscopic surgery among members of the Society of Gynecologic Oncology (SGO). Methods A 23-item questionnaire was sent to all working/eligible SGO member e-mail addresses (n = 1356). Data were collected and analyzed using descriptive statistics. χ2 was used to determine differences in responses between groups. Results Of the 287 (21.2%) responding SGO members, most (61.3%) estimated the risk of VTE for laparoscopic surgery between 1% and 2%. Most (51.2%) of respondents did not routinely use preoperative pharmacoprophylaxis, and most discontinued prophylaxis upon hospital discharge, regardless of benign (73.5%) or malignant (53.3%) pathology. Combination prophylaxis was preferred for procedures in the setting of intermediate- (50.2%) or high-complexity (78%), malignancy (70.7%), obesity (71.4%), multiple medical comorbidities (76%), or the elderly (64.5%). When compared with respondents of greater surgical volume, respondents who performed less than 5 laparoscopic cases per month were more likely to use sequential compression devices alone in the setting of malignancy (52.6%, P = 0.025). The omission of VTE prophylaxis was rare and varied depending on the patient scenario (0.7%–3.5%). When compared with younger respondents, those who were 61 to 70 years old more frequently omitted VTE prophylaxis in the setting of low-complexity procedures (22.2%, P = 0.003), obesity (11.1%, P = 0.021), multiple medical comorbidities (11.1%, P = 0.008), and the elderly (11.1%, P = 0.009). Conclusions Among SGO members, the preferred method of VTE prophylaxis during laparoscopic surgery for several high-risk patient scenarios was combination prophylaxis. The use versus nonuse and the preferred method of VTE prophylaxis were influenced by respondent age and surgical volume.

Increased single‐balloon Foley catheter volume for induction of labor and time to delivery: a systematic review and meta‐analysis

Induction of labor is a common intervention. The objective was to investigate whether larger Foley catheter volumes for labor induction decrease the total time from induction to delivery.

Foley catheter for induction of labour filled with 30 mL or 60 mL: A randomized controlled trial

OBJECTIVES One of the methods used to induce labour is the placement of a transcervical Foley catheter (FC). The aim of this randomized controlled study was to assess in term pregnant women with an unfavourable cervix, whether there is a difference in efficacy between the two most commonly used insufflation volumes of FC (30mL and 60mL). STUDY DESIGN Randomized controlled trial. RESULTS Women were randomized to induction of labour with a Foley catheter filled with 30mL or with 60mL. Primary outcome was delivery within eight hours after amniotomy. Secondary outcomes included the time interval between placement of the Foley and amniotomy, the mode of delivery, complications and neonatal outcomes. In total, 174 women (87 in each arm) were randomized. The number of deliveries within eight hours after amniotomy was not significantly different between the two groups (40.7% versus 48.83%, OR=0.71(CI; 0.39-1.3)). Sub-analysis showed that more multiparous women in the 60mL group delivered within eight hours (93.10% versus 65.22%, OR=7.2 (CI; 1.35-38.37)). For the nulliparous, the 30mL Foley catheter was associated with a higher caesarean section rate (31.75% versus 15.52% (OR 2.53; CI; 1.1-6.2)). The 60mL Foley catheter was also associated with a higher chance of spontaneous labour after placement (OR 2.35; CI; 1.1-5.1), a shorter time interval for cervical ripening (OR=4.5; CI: 1.2-16.7) and less blood loss. (p=0.002). The Foley catheter ruptured twelve times in the 60mL group whereas this did not happen once in the 30mL group. One case of umbilical cord prolapse was observed in the 60mL group. No differences in neonatal outcomes and patient satisfaction were seen. CONCLUSIONS For our primary outcome, no difference was observed between the Foley catheter balloon filled with 60mL and the one filled with 30mL. Yet, a Foley catheter filled with 60mL was associated in multiparous women with a higher rate of deliveries within eight hours after amniotomy and in nulliparous with a significantly lower caesarean section rate. These latest findings should be interpreted with cautious as underpowered.

Towards spill-free in-bag morcellation : a health failure mode and effects analysis

BackgroundTo assess potential risks of new surgical procedures and devices before their introduction into daily practice, a prospective risk inventory (PRI) is a required step. This study assesses the applicability of the Health Failure Mode and Effects Analysis (HFMEA) as part of a PRI of new technology in minimally invasive gynecologic surgery.MethodsA reference case was defined of a patient with presumed benign leiomyoma undergoing a laparoscopic hysterectomy or myomectomy including in-bag power morcellation; however, pathology defined a stage I uterine leiomyosarcoma. Using in-bag morcellation as a template, a HFMEA was performed. All steps of the in-bag morcellation technique were identified. Next, the possible hazards of these steps were explored and possible measures to control these hazards were discussed.ResultsFive main steps of the morcellation process were identified. For retrieval bags without openings to accommodate instruments inside the bag, 120 risks were identified. Of these risks, 67 should be eliminated. For containment bags with openings 131 risks were identified of which 68 should be eliminated. Of the 10 causes most at risk to cause spillage, two can be eliminated by using appropriate bag materials. Myomectomy appears to be more at risk for residual tissue spillage compared to total hysterectomy.ConclusionThe HFMEA has provided important new insights regarding potential weaknesses of the in-bag morcellation technique, particularly with respect to hazardous steps in the morcellation process as well as requirements that bags should meet. As such, this study has shown HFMEA to be a valuable method that identifies and quantifies potential hazards of new technology.

Laparoscopic hysterectomy for benign indications: clinical practice guideline

PurposeSince the introduction of minimally invasive gynecologic surgery, the percentage of advanced laparoscopic procedures has greatly increased worldwide. It seems therefore, timely to standardize laparoscopic gynecologic care according to the principles of evidence-based medicine. With this goal in mind—the Dutch Society of Gynecological Endoscopic Surgery initiated in The Netherlands the development of a national guideline for laparoscopic hysterectomy (LH). This present article provides a summary of the main recommendations of the guideline.MethodsThis guideline was developed following the Dutch guideline of medical specialists and in accordance with the AGREE II tool. Clinically important issues were firstly defined and translated into research questions. A literature search per topic was then conducted to identify relevant articles. The quality of the evidence of these articles was rated following the GRADE systematic. An expert panel consisting of 18 selected gynecologists was consulted to formulate best practice recommendations for each topic.ResultsTen topics were considered in this guideline, including amongst others, the different approaches for hysterectomy, advice regarding tissue extraction, pre-operative medical treatment and prevention of ureter injury. This work resulted in the development of a clinical practical guideline of LH with evidence- and expert-based recommendations. The guideline is currently being implemented in The Netherlands.ConclusionA guideline for LH was developed. It gives an overview of best clinical practice recommendations. It serves to standardize care, provides guidance for daily practice and aims to guarantee the quality of LH at an (inter)national level.