Rate Of Intraoperative Adverse Events Research Articles

Time to medical fitness for discharge following surgical evacuation of chronic subdural haematoma with general or regional anaesthesia: a prospective randomised trial.

General or regional anaesthesia can be used for chronic subdural haematoma evacuation, but no study has compared these types of anaesthesia in terms of peri-operative outcomes. This single-centre, prospective, randomised study included adult patients (age ≥ 18 years) undergoing surgical chronic subdural haematoma evacuation. Patients were randomly allocated to general (target-controlled total intravenous anaesthesia with propofol and remifentanil) or regional anaesthesia (bilateral scalp block with remifentanil sedation if required). The primary outcome measure was duration of hospital stay, based on the day patients were judged by an investigator blinded from the allocation group to be medically fit for discharge. Secondary outcomes included: rate of regional anaesthesia failure; rate of intra-operative and postoperative adverse events at 24 hours; and pain scores at 24 hours. Data from 60 patients were analysed (30 general anaesthesia and 30 regional anaesthesia). Median (IQR [range]) time until patients were judged medically fit for discharge was 3 (3-3 [2-10]) days and 3 (2-5 [2-15]) days for general and regional anaesthesia, respectively (p = 0.700). Regional anaesthesia failed in two patients. There were more intra-operative adverse events in patients who received general anaesthesia (25 vs. 11, respectively; p = 0.001). The occurrence of postoperative adverse events was similar for general and regional anaesthesia (16 vs. 13 patients, respectively; p = 0.605). In patients requiring chronic subdural haematoma evacuation, general and regional anaesthesia are comparable in terms of duration of time until medically fit for discharge and occurrence of postoperative complications. The rate of intra-operative adverse events (mainly arterial hypotension) is greater with general anaesthesia.

Intraoperative protective ventilation in patients undergoing major neurosurgical interventions: a randomized clinical trial

BackgroundPost-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery.MethodsThis single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality.ResultsA total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups.ConclusionsLPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements.Trial registrationregistered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.

Retrograde Open Mesenteric Stenting for Acute and Chronic Mesenteric Ischaemia: Results from an Intestinal Stroke Centre

To report the intra-operative adverse events (IOAEs) and the initial and one year outcomes of retrograde open mesenteric stenting (ROMS) using balloon expandable covered stents for acute and chronic mesenteric ischaemia. Clinical data and outcomes of all consecutive patients treated with ROMS for acute and chronic mesenteric ischaemia at an intestinal stroke centre between November 2012 and September 2019 were reviewed. ROMS was performed using balloon expandable covered stents. Endpoints included IOAEs, in hospital mortality, post-operative complications, and re-interventions. One year overall survival, freedom from re-intervention, primary patency and assisted primary patency rates were analysed using the Kaplan-Meier time to event method. During the study period, 379 patients were referred to the centre for acute or chronic mesenteric ischaemia. Thirty-seven patients who underwent the ROMS procedure were included. All the patients had severe atherosclerotic mesenteric lesions. The ROMS technical success rate was 89% in this cohort. The rate of IOAEs was 19% and included four cases of retrograde recanalisation failure. All ROMS failures occurred in patients presenting with flush superior mesenteric artery occlusion and they were treated by mesenteric bypass. Ten patients (27%) underwent bowel resection, four of which resulted in a short bowel syndrome (11%). The in hospital mortality rate was 27%. Post-operative complications and re-intervention rates were 67% (n= 25) and 32% (n= 12), respectively. The median follow up was 20.2 months (interquartile range 29). The estimated one year overall survival for the cohort was 70.1% (95% confidence interval [CI] 52.5% - 82.2%). The estimated freedom from re-intervention at one year was 61.1% (95% CI 42.3 - 75.4). The one year primary patency and assisted primary patency rates were 84.54% (95% CI 63.34 - 94) and 92.4% (95% CI 72.8 - 98), respectively. ROMS procedures offer acceptable one year outcomes for mesenteric ischaemia but are associated with frequent stent related complications. Precise pre-operative planning, high quality imaging, and meticulous stent placement techniques may limit the occurrence of such events.

Perioperative adverse events in women over age 65 undergoing robot-assisted sacrocolpopexy.

Pelvic floor disorders are common among and disproportionately affect older women. There are limited data regarding perioperative adverse events in older women undergoing robot-assisted sacrocolpopexy (RASC) specifically. The aim of this study was to compare the rate of perioperative adverse events in younger (age <65years) versus older (age>65years) women who underwent RASC. We conducted a retrospective cohort study of women who underwent RASC between 2013 and 2018. Postoperative adverse events were categorized according to the Clavien-Dindo classification. Our primary outcome was the rate of intraoperative adverse events and postoperative adverse events with Clavien-Dindo grade II or greater. Outcomes were compared using univariate and multivariate analysis. Of the 327 patients included in the study, 227 were <65years of age and 100 were≥65years of age. Women ≥65years of age had higher rates of hypertension, higher American Society of Anesthesiologist (ASA) class, and higher Charlson Comorbidity Index (CCI) scores compared with women <65years of age; these were not associated with increased likelihood of adverse events. The overall rate of any perioperative adverse event was 18.3%. There was no statistically significant difference in the overall rate of perioperative adverse events between younger and older women (18.5% vs 18.0%, p = 0.91). There is no difference in rate of adverse events between women ≥65years of age undergoing RASC and their younger counterparts.

The impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for the large uterus

There are currently sparse data on the relationship between surgeon- and patient-related factors and perioperative morbidity in the setting of elective hysterectomy for the larger uterus. We sought to evaluate the impact of surgeon case volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for uteri >250 g. This is a retrospective cohort study of all women who underwent total vaginal, total laparoscopic, laparoscopic-assisted vaginal, or robotic-assisted total laparoscopic hysterectomy from January 2014 through July 2016. Hysterectomy was performed for: fibroids, pelvic pain, abnormal uterine bleeding, or prolapse. Patients were identified by Current Procedural Terminology codes and the systemwide electronic medical record was queried for demographic and perioperative data. Perioperative adverse events were defined a priori and classified using the Clavien-Dindo scale. Surgeon case volume was defined as the mean number of minimally invasive hysterectomy cases performed per month by each surgeon during the study period. In all, 763 patients met inclusion criteria: 416 (54.5%) total laparoscopic hysterectomy, 196 (25.7%) robotic-assisted total laparoscopic hysterectomy, 90 (11.8%) total vaginal hysterectomy, and 61 (8%) laparoscopic-assisted vaginal hysterectomy. Mean (±SD) age was 47.3 ± 6.1 years, and body mass index was 31.1 ± 7.4 kg/m2. In all, 66 surgeons performed minimally invasive hysterectomy for uteri >250 g during the study period, and the median rate of minimally invasive hysterectomy cases for large uteri per month was 3.4 (0.4-3.7) cases/month. The median (IQR) uterine weight was 409 (308-606.5) g. The rate of postoperative adverse events Dindo grade >2 was 17.8% (95% confidence interval, 15.2-20.7). The overall rate of intraoperative adverse events was 4.2% (95% confidence interval, 2.9-5.9). The rate of conversion to laparotomy was 5.5% (95% confidence interval, 4.0-7.4). There was no significant difference in adverse event rates between the routes of minimally invasive hysterectomy cases (25.6% vs 17.5% vs 18.0% vs 14.8% for total laparoscopic hysterectomy, robotic-assisted laparoscopic hysterectomy, total vaginal hysterectomy, and laparoscopic-assisted vaginal hysterectomy, respectively, P= .2). In a logistic regression model controlling for age, body mass index, uterine weight, operating time, and history of laparotomy, higher monthly minimally invasive hysterectomy volume was significantly associated with the likelihood that a patient would experience a postoperative adverse event (adjusted odds ratio, 1.1 for each additional minimally invasive hysterectomy case for large uteri per month; 95% confidence interval, 1.0-1.3). When controlling for the same variables, a higher incidence of intraoperative complications was significantly associated with monthly minimally invasive hysterectomy case volume (adjusted odds ratio, 1.5 for each additional minimally invasive hysterectomy case for large uteri per month; 95% confidence interval, 1.20-2.08). Increasing age was associated with a lower incidence of complications (adjusted odds ratio, 0.9 for each additional year; 95% confidence interval, 0.8-0.9). Higher monthly minimally invasive hysterectomy volume was associated with a lower rate of conversion from a minimally invasive approach to laparotomy (adjusted odds ratio, 0.4 for each additional minimally invasive hysterectomy case for large uteri per month; 95% confidence interval, 0.2-0.5). The overall rate of serious adverse events associated with minimally invasive hysterectomy for uteri >250 g was low. Higher monthly minimally invasive hysterectomy case volume was associated with a higher rate of intraoperative and postoperative adverse events but was associated with a lower rate of conversion to laparotomy.

Are surgeons reluctant to accurately report intraoperative adverse events? A prospective study of 1,989 patients

BackgroundThe true incidence of intraoperative adverse events (iAEs) remains unknown. MethodsAll patients undergoing abdominal surgery at an academic institution between January and July 2016 were included in a prospective fashion. At the end of surgery, using a secure REDCap database, the surgeon was given the Institute of Medicine definition of intraoperative adverse events and asked whether an intraoperative adverse event had occurred. Blinded reviewers systematically examined all operative reports for intraoperative adverse events and their severity. The response rate and the intraoperative adverse event rate reported by surgeons were calculated. The latter was compared with the rate of intraoperative adverse events detected by operative report review. The severity of intraoperative adverse events was assessed based on a previously validated intraoperative adverse event classification system. ResultsA total of 1,989 operations were included. The surgeons’ response rate was 71.9%, reporting intraoperative adverse events in 107 operations (7.5%). Of those intraoperative adverse events, 26 (24.3%) were not described in the operative report. Operative report review revealed intraoperative adverse events in 417 operations (21.0%). Most injuries were of lower severity (85.8% were either class I or II). The surgeons’ response rate was similar in operations with and without intraoperative adverse events (69.8% versus 72.5%, P=.28), but they underreported low severity intraoperative adverse events—only 13.2% of class I compared with 35.3%, 36.8%, and 55.6% of injury classes II, III, and IV respectively (P<.001). ConclusionSurgeons are willing to report intraoperative adverse events, but systematically and significantly underreport them, especially if they are of lower severity. This is potentially related to the absence of a clear intraoperative adverse event definition or their personal interpretation of their clinical significance.

12: The impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for large uteri

To evaluate the impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy (MIH) for uteri >250 grams. This is a retrospective cohort study of all women who underwent vaginal (VH), laparoscopic (TLH), laparoscopic-assisted vaginal (LAVH), or robotic-assisted laparoscopic hysterectomy (RH) between January 2014 and July 2016 at a tertiary care referral center. Hysterectomy was performed for the following indications: fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Women were excluded if there was a preoperative diagnosis of malignancy. Patients were identified by Current Procedural Terminology codes and the system-wide electronic medical record was queried for demographic and perioperative data. Perioperative adverse events were defined a priori and classified using the Clavien-Dindo scale. Surgeon volume was defined as the mean number of MIH cases performed per month by each surgeon during the study period. Seven hundred sixty-three patients met inclusion criteria: 416 (54.5%) TLH, 196 (25.7%) RH, 90 (11.8%) TVH, and 61 (8%) LAVH. Mean (±SD) age was 47 ± 6 years, and body mass index (BMI) was 31.1 ± 7.4 kg/m2. Sixty-six surgeons performed MIH for uteri >250 grams during the study period. The mean monthly case volume was 16.4 ± 7.2 cases, and the median MIH volume was 23 cases (range: 1–147 cases). The mean uterine weight was 522.8 ± 322.7 grams. The rate of postoperative adverse events >Dindo grade 2 was 17.8% (95% CI = 15.2-20.7); 2.2% (95% CI = 1.4-3.6) were grade 3 and 0.5% (95% CI = 0.7-1.4) grade 4; there were no grade 5 adverse events. The overall rate of intraoperative adverse events was 4.2% (95% CI = 2.9-5.9). The rate of conversion to laparotomy was 5.5% (95% CI = 4.0-7.4). There was no difference in adverse event rates between the routes of MIH cases (25.6% vs. 17.5% vs. 18.0% vs. 14.8%, p = 0.2). Women who experienced any adverse event compared to those who did not were more likely to be of Hispanic, Asian or “other” ethnicity, had higher intraoperative blood loss (EBL) and longer operating case time. In a logistic regression model controlling for age, BMI, uterine weight, operating time, history of laparotomy and parity, higher monthly MIH volume remained significantly associated with adverse events (adjOR = 1.14, 95% CI = 1.0-1.3, p = 0.01), as did higher EBL (adjOR = 1.4, 95% CI = 1.1-1.8, p = 0.006). When controlling for the same variables, higher monthly MIH case volume remained significantly associated with intraoperative complications (adjOR = 1.30, 95% CI = 1.0-1.6, p = 0.02) as well as higher EBL (adjOR = 3.1, 95% CI = 2.0-4.9, p < 0.001). Conversion from a minimally invasive approach to laparotomy was not associated with monthly MIH case volume; however, conversion was associated with higher EBL (adjOR = 2.9, 95% CI = 1.8-4.9) and heavier uteri (adjOR = 9.7, 95% CI = 3.9-23). The overall rate of serious adverse events associated with MIH for uteri >250 grams was low. Higher EBL and longer operative times were associated with higher perioperative adverse event rates. Higher monthly MIH case volume was associated with a higher rate of intra- and postoperative adverse events but was not associated with conversion to laparotomy.

Safety and Feasibility Analysis of Laparoscopic Lymphadenectomy in Pelvic Gynecologic Malignancies: A Prospective Study.

The aims of this study were to evaluate prospectively the safety and feasibility of laparoscopic lymphadenectomy in gynecologic oncology and to analyze risk factors associated with surgical adverse events. This study included 444 consecutive laparoscopic lymphadenectomy procedures conducted in 358 consecutive gynecologic oncology patients, between 2007 and 2014. Surgical adverse events were classified into intraoperative, early postoperative (≤6 weeks after surgery), and late postoperative (>6 weeks after surgery). Logistic regression analysis was used to assess the independent effects of different variables on the probability of complications. Differences were considered to be statistically significant for P values less than 0.05. Two hundred forty-four pelvic lymphadenectomy and 200 aortic lymphadenectomy procedures were carried out during the studied period. All pelvic lymphadenectomy procedures were conducted with a transperitoneal approach, whereas 94.5% of aortic lymphadenectomy procedures were conducted with an extraperitoneal approach. A total of 52.2% of tumors were found to originate in the cervix, 38% in the endometrium, 6.4% in the ovary, 2.8% were sarcoma, and 0.6% were in a different region. The laparotomy conversion rate was 2.8%. The rate of intraoperative adverse events was 1.9%, the most frequent ones being vascular injuries followed by ureteral, bowel, or neurologic injuries. The rate of early-postoperative adverse events was 3.3%, the most frequent one being incisional hernia followed by hemoperitoneum, pelvic abscess, intestinal injury, and paralytic ileus. One patient with endometrial cancer died after surgery due to sepsis of unknown origin. The rate of late-postoperative adverse events was 3.6% and consisted mainly of symptomatic lymphocele or lymphedema. A logistic regression analysis showed that factors associated with increased risk of lymphadenectomy surgical complications were surgical bleeding and operative time (odds ratio, 2.6; 95% confidence interval, 1.1-6; P = 0.02 and odds ratio, 2.6; 95% confidence interval, 1-6.7; P = 0.04). Laparoscopic lymphadenectomy is a safe and feasible procedure in gynecologic oncology but not free of complications. We postulate that gynecologic oncologists should be properly trained in the management of such complications and be aware of the importance of adequate hemostasis and operating time during surgery.

Intraoperative adverse events during laparoscopic colorectal resection—better laparoscopic treatment but unchanged incidence. Lessons learnt from a Swiss multi-institutional analysis of 3,928 patients

Intraoperative adverse events significantly influence morbidity and mortality of laparoscopic colorectal resections. Over an 11-year period, the changes of occurrence of such intraoperative adverse events were assessed in this study. Analysis of 3,928 patients undergoing elective laparoscopic colorectal resection based on the prospective database of the Swiss Association of Laparoscopic and Thoracoscopic Surgery was performed. Overall, 377 intraoperative adverse events occurred in 329 patients (overall incidence of 8.4%). Of 377 events, 163 (43%) were surgical complications and 214 (57%) were nonsurgical adverse events. Surgical complications were iatrogenic injury to solid organs (n = 63; incidence of 1.6%), bleeding (n = 62; 1.6%), lesion by puncture (n = 25; 0.6%), and intraoperative anastomotic leakage (n = 13; 0.3%). Of note, 11% of intraoperative organ/puncture lesions requiring re-intervention were missed intraoperatively. Nonsurgical adverse events were problems with equipment (n = 127; 3.2%), anesthetic problems (n = 30; 0.8%), and various (n = 57; 1.5%). Over time, the rate of intraoperative adverse events decreased, but not significantly. Bleeding complications significantly decreased (p = 0.015), and equipment problems increased (p = 0.036). However, the rate of adverse events requiring conversion significantly decreased with time (p < 0.001). Patients with an intraoperative adverse event had a significantly higher rate of postoperative local and general morbidity (41.2 and 32.9% vs. 18.0 and 17.2%, p < 0.001 and p < 0.001, respectively). Intraoperative surgical complications and adverse events in laparoscopic colorectal resections did not change significantly over time and are associated with an increased postoperative morbidity.

Bovine versus Porcine Acellular Dermal Matrix for Complex Abdominal Wall Reconstruction

Abdominal wall reconstruction with bioprosthetic mesh is associated with lower rates of mesh infection, fistula formation, and mesh explantation than reconstruction with synthetic mesh. The authors directly compared commonly used bioprosthetic meshes in terms of clinical outcomes and complications. A database of consecutive patients who underwent abdominal wall reconstruction with porcine or bovine acellular dermal matrix and midline musculofascial closure at their institution between January of 2008 and March of 2011 was reviewed. Surgical outcomes were compared. One hundred twenty patients were identified who underwent a nonbridged, inlay abdominal wall reconstruction with porcine [69 patients (57.5 percent)] or bovine acellular dermal matrix (51 patients (42.5 percent)]. The mean follow-up time was 21.0 ± 9.9 months. The overall complication rate was 36.6 percent; the porcine matrix group had a significantly higher complication rate (44.9 percent) than the bovine matrix group (25.5 percent; p = 0.04) and statistically equivalent surgical complications (29.2 percent versus 21.6 percent; p = 0.34). There were no significant differences in rates of recurrent hernia (2.9 percent versus 3.9 percent; p = 0.99) or bulge (7.2 percent versus 0 percent; p = 0.07). However, the rate of intraoperative adverse events in the porcine matrix group [seven events (10.1 percent)] was significantly higher than that in the bovine matrix group (0 percent; p = 0.02). In patients who undergo complex abdominal wall reconstruction, both bovine and porcine acellular dermal matrix are associated with similar rates of postoperative surgical complications and appear to result in similar outcomes. Porcine acellular dermal matrix may be prone to intraoperative device failure. Therapeutic, III.

Mesh erosions after transobturator suburethral tape: a case series

The transobturator tape (TOT) is a widely used minimally invasive procedure for the treatment of stress urinary incontinence (SUI). Despite the reported low rate of intraoperative adverse events after TOT, many cases of delayed vaginal erosion were published and are cause of great concern. We reviewed our experience with the TOT procedure using Uratape® (Mentor-Porges, Le Plessis Robinson, France), a non-woven, non-elastic polypropylene tape. In our series of 102 patients treated with TOT for SUI, we noted three cases of delayed vaginal wall erosion (2.9%). All patients were treated with excision of the eroded portion of the tape. Other reports have shown, in some cases, a considerably higher rate of erosion after TOT using the same mesh. Further investigation is needed to evaluate prospectively the relationship between the type of mesh used for surgery and erosions, and the possible aetiological role of other concomitant factors.