Incidence Of Intraoperative Adverse Events Research Articles

Clinical trial to test the safety of the EVA Nexus surgical platform

BackgroundThe EVA Nexus system offers several technical improvements over its predecessor. The newly designed Aveta cannula system for vitrectomy surgery avoids the need for removal of the valve from the infusion cannula. The chamfered leading edge of the cannula also reduces the insertion force needed. The new EquiPhaco needles in combination with SmartIOP provide excellent anterior chamber stability during phaco-emulsification surgery, enabling to work at lower infusion pressures, and the multiburst phaco mode allows easier removal of hard cataracts. The system offers a secondary active infusion line for independent control of pressure to the anterior and posterior chambers, monitoring of flow rate/reflux and warning of infusion bottle emptying. This study evaluated whether these technical improvements result in improved surgical safety.MethodsIn total, 250 eyes that underwent vitrectomy (53%) or phaco-vitrectomy (47%) using the EVA Nexus system were prospectively included. The occurrence of intraoperative adverse events was compared to that of historically operated eyes using the EVA system.ResultsThe average age of the patients was 63 years. A total of 33% of the patients were operated on for retinal detachment, 17% for macular pucker, 11% for treating floaters, 9% for removing silicone oil, 8% for macular hole repair and 22% for other diseases. In 75% of surgeries, 23 G instruments were used, and 27 G instruments were used in 25% of cases. Device issues that occurred included priming cycle issues (n = 4), eye pressure stability problems (n = 6) and vitrectome performance issues (n = 1), all of which in the first 100 patients who were included and were fixed with software updates. The frequency of surgical complications in the anterior segment was lower than that in the historically recorded surgical reports. Intraoperative events in the posterior segment included hemorrhage from retinal vessels, choroidal hematoma, iatrogenic retinal damage/tear, and subchoroidal infusion. Again, these events occurred rarely and less frequently than in the historical surgical reports.ConclusionsThe EVA Nexus provides a surgical platform that reduces the incidence of intraoperative adverse events and iatrogenic complications in both anterior and posterior segment surgery. This could increase surgical safety during cataract and vitrectomy surgery.Trial Registration number Clinicaltrials.gov: NCT05229094 Data 22/5/2021.

Modified peroral endoscopic myotomy technique with retrograde on-demand myotomy for achalasia: a retrospective cohort study (with video).

Although myotomy is crucial in peroral endoscopic myotomy (POEM) surgeries, its optimum length remains controversial. Herein, we propose a modified POEM with new method of tailoring myotomy length aim to evaluate the safety, efficacy, and clinical outcomes of this modified POEM compared with standard POEM in type I or II achalasia. Seventy-five patients with type I or II achalasia who underwent POEM at the First Hospital of Jilin University between January 2018 and December 2022 were retrospectively analyzed. According to the myotomy approach, these patients were divided into the retrograde on-demand myotomy (RDM, n = 34), with myotomy beginning on gastric side and length tailored by determining the degree of lower esophageal sphincter (LES) distention, and standard myotomy (SM, n = 41) groups. The baseline data, myotomy length, operation time, clinical success rate, adverse event rate, and reflux-related adverse events were compared and analyzed. The median myotomy length in the RDM group was significantly shorter than that in the SM group (6 vs. 8cm, respectively; p < 0.001). Moreover, the median myotomy time in the RDM group was significantly shorter than that in the SM group (10 vs. 16min, respectively; p < 0.001). POEM was successfully performed in all the patients. At the 2-year follow-up, high clinical success rates were observed in both the RDM and SM groups (92.0% vs. 93.3%, respectively; p = 1.000). The incidence of intraoperative adverse events and postoperative reflux-related adverse events was low and comparable in both groups. RDM POEM is a safe and effective method for patients with type I or II achalasia. Furthermore, it has a shorter myotomy length and operation time than standard POEM technique.

Evaluation of the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children: study protocol for a prospective, multicenter, randomized, open-label, parallel-group, pragmatic clinical trial

BackgroundInadequate postoperative pain management increases the risk of adverse events after the surgery and aggressive perioperative pain prevention has both short-term and long-term benefits. S(+)-ketamine is an N-methyl-D-aspartic acid (NMDA) receptor antagonist with a strong analgesic effect and can significantly relieve postoperative acute pain and reduce opioid consumption. However, for children, it still needs to be confirmed by large sample clinical studies.MethodsThis is a pragmatic, randomized controlled trial which will evaluate the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children in a pragmatic clinical setting. A total of 3000 children (≤17 years old) undergoing surgery will be included in this protocol. Subjects will be randomized 2:1 to either receive S(+)-ketamine hydrochloride injection or conventional therapy without S(+)-ketamine during the entire perioperative period. The primary endpoints are the area under the receiver operating characteristic (ROC) curve of Face Legs Activity Cry and Consolability (FLACC, 0–7 years old) scale score or Numerical Rating Scale (NRS, 8–17 years old) score within 48 h after surgery, and the consumption of opioids within 48 h after surgery. The secondary endpoints include the time of first use of rescue analgesics after surgery, rescue analgesia rate within 48 h after surgery, anesthesia recovery time, incidence of emergency delirium (for 0-7 years old), changes of anxiety and depression scale scores at 48 h after surgery (for 8-17 years old), incidence of intraoperative adverse events (AEs), and incidence of postoperative AEs and pharmacoeconomic indicators. AEs and serious AEs were recorded to evaluate safety.DiscussionThis trial will be the first pragmatic clinical trial to prospectively assess the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children, which is of great significance to the continuous optimization of clinical anesthesia and analgesia programs for children.Trial registrationThis trial was registered in the U.S. National Institutes of Health ClinicalTrials.gov database (http://clinicaltrials.gov; Registration number: NCT04834427). Registered on 8 April 2021.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms

Objective To evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs).

Intraoperative pH Is a Reliable Prognostic Factor for Patients With Periampullary Carcinoma Undergoing Pancreaticoduodenectomy.

A reliable prognostic factor for periampullary carcinoma is critical to improve surgical outcomes. Intraoperative acidosis reflects the incidence of intraoperative adverse events and impact the prognosis. In this study, 612 patients with periampullary carcinoma who underwent pancreaticoduodenectomy (PD) were divided into high- and low-pH groups according to the cut-off value of receiver operating characteristic curve (7.34). Through statistical analysis of the difference between the high- and low-pH group, it was found that the low-pH group had worse short-term prognosis than the high pH group, and intraoperative pH was an independent prognostic factor for patients with periampullary carcinoma undergoing PD. In addition, patients who underwent laparoscopic pancreaticoduodenectomy had a more alkaline pH after surgery. This is of great help for early judgment of short-term and even long-term prognosis of patients with pancreatic cancer after surgery, and can even guide clinicians to improve prognosis by early adjustment of pH value.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms

ObjectiveTo evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs). MethodsWe reviewed the clinical and imaging data of 600 consecutive patients (445 males; mean age, 75 ± 8 years) who underwent FB-EVAR between 2007 and 2019 in a single institution. IAE was defined as any intraoperative complication or technical problem requiring additional and unplanned procedures, and was classified as access-related, target artery (TA)-related, or graft-related. End points included rates of IAEs, 30-day or in-hospital mortality, major adverse events, patient survival, freedom from secondary intervention, and TA instability. ResultsA total of 122 IAEs were identified in 105 patients (18%). IAEs were TA-related in 55 patients (9%), access-related in 46 patients (8%), and graft-related in seven patients (1%). Female sex was more frequent among patients with IAEs (44% vs 22%; P < .001). Patients with IAEs had smaller renal artery diameter (−0.4 mm, 5.4 ± 0.8 mm vs 5.8 ± 0.9 mm; P < .001), and were treated more often for TAAAs (72% vs 54%; P < .03). Technical success was achieved in 96.5% of patients and was lower for patients with IAEs (82% vs 99%; P < .001). Major adverse events were significantly more frequent among patients who had IAEs (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.21-3.25), most due to acute kidney injury (27% vs 11%; P < .001) including new-onset dialysis (5% vs 1%; P = .01). On multivariate logistic regression model, female sex (OR, 2.5; 95% CI, 1.5-4.0), TA stenosis >50% (OR, 2.0; 95% CI, 1.3-3.3), and Crawford Extent II TAAA (OR, 1.9; 95% CI, 1.1-3.3) were predictive of IAEs, whereas preloaded design (OR, 0.6; 95% CI, 0.4-0.9) and TA diameter (+1 mm; OR, 0.6; 95% CI, 0.4-0.9) were protective of IAEs. IAEs negatively affected secondary intervention (hazard ratio [HR], 1.6; 95% CI, 1.1-2.3) and TA instability (HR, 2.5; 95% CI, 1.2-5.4); however, IAEs did not affect patient survival (HR, 1.0; 95% CI, 0.7-1.4). ConclusionsIAEs are common, occurring in nearly one of five patients treated with FB-EVAR for complex aortic aneurysms, and have a negative impact on clinical outcomes. IAEs were associated with female sex, TA diameter, and more extensive aortic disease.

The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial \u2014 EURO-RELAX TRIAL

BackgroundMuscle relaxants are routinely used during anesthesia to facilitate endotracheal intubation and to optimize surgical conditions. However, controversy remains about the required depth of neuromuscular block (NMB) needed for optimal surgical working conditions and how this relates to other outcomes. For instance, a deep neuromuscular block yields superior surgical working conditions compared to a standard NMB in laparoscopic surgery, however, a robust association to other (safety) outcomes has not yet been established.MethodsTrial design: an international multicenter randomized controlled double-blind strategy trial.Trial population: 922 patients planned for elective, laparoscopic or robotic, abdominal surgery.Intervention: Patients will be randomized to a deep NMB (post-tetanic count 1–2 twitches) or standard care (single-dose muscle relaxant administration at induction and repeated only if warranted by surgical team).Main trial endpoints: Primary endpoint is the difference in incidence of intraoperative adverse events during laparoscopic surgery graded according to ClassIntra® classification (i.e., ClassIntra® grade ≥ 2) between both groups. Secondary endpoints include the surgical working conditions, 30-day postoperative complications, and patients’ quality of recovery.DiscussionThis trial was designed to analyze the effect of deep neuromuscular block compared to standard neuromuscular block on intra- and postoperative adverse events in patients undergoing laparoscopic surgery.Trial registrationClinicalTrials.gov NCT04124757(EURO-RELAX); registration URL: https://clinicaltrials.gov/ct2/show/NCT04124757, registered on October 11th, 2019.

Laparoscopic nerve\u2011sparing radical hysterectomy for the treatment of cervical cancer: a meta-analysis of randomized controlled trials

BackgroundThe effects and safety of laparoscopic nerve‑sparing radical hysterectomy (LNSRH) and laparoscopic radical hysterectomy (LRH) in cervical cancer treatment remain unclear. This article aims to evaluate the role of LNSRH versus LRH in the treatment of cervical cancer. This is because the updated meta-analysis with synthesized data may provide more reliable evidence on the role of LNSRH and LRH.MethodsWe searched Pubmed et al. databases for randomized controlled trials (RCTs) involving laparoscopic nerve‑sparing radical hysterectomy (LNSRH) and laparoscopic radical hysterectomy (LRH) for cervical cancer treatment from the inception of databases to June 15, 2021. The RevMan 5.3 software was used for data analyses. This meta-analysis protocol had been registered online (available at: https://inplasy.com/inplasy-2021-9-0047/).ResultsThirteen RCTs involving a total of 1002 cervical cancer patients were included. Synthesized results indicated that the duration of surgery of the LNSRH group was significantly longer than that of the LRH group [SMD 1.11, 95% CI (0.15 ~ 2.07), P = 0.02]. The time to intestinal function recovery [SMD −1.27, 95% CI (−1.84 ~ −0.69), P < 0.001] and the time to postoperative urinary catheter removal of the LNSRH group [SMD −1.24, 95% CI (−1.62 ~ −0.86), P < 0.001] were significantly less than that of the LRH group. There were no significant differences in the estimated blood loss [SMD 0.10, 95% CI (−0.14 ~ 0.34), P = 0.41], the length of parauterine tissue resection [SMD −0.10, 95% CI (−0.25 ~ 0.05), P = 0.19], length of vaginal excision [SMD 0.04, 95% CI (−0.26 ~ 0.34), P = 0.78], and incidence of intraoperative adverse events [RR 0.97, 95% CI (0.44 ~ 2.13), P = 0.94] between the LNSRH group and the LRH group.ConclusionsLNSRH significantly results in earlier bladder and bowel function after surgery. Limited by sample size, LNSRH should be considered with caution in the future.

A multicentre study of the trend of adverse events during outpatient anaesthesia in Switzerland during 2000-2016.

Over the last three decades, the use of outpatient surgery has been steadily increasing. Simultaneously, there has been an inciting movement to measure and improve healthcare quality and safety. Nevertheless, anaesthesia-related morbidity remains significant. We aimed to evaluate the incidence of intraoperative adverse events (IAEs) occurring during outpatient surgery. We used data from the Anaesthesia Databank Switzerland (ADS), a voluntary register. We assessed the overall and specific incidence of IAEs, according to a predefined list of technical, cardiovascular, organisational, respiratory, and general incidents in Switzerland between 2000 and 2016. Primary and secondary outcomes were modelled using multi-level logistic regression analysis, and the time trend on the probabilities of events was assessed. Between 2000 and 2016, 289,948 outpatient anaesthesia procedures were performed. During this period, the estimated probability of overall intraoperative adverse events decreased from 10.8% to 6.3%, and from 2.3% to 1.4% for technical incidents, from 3.0% to 2.2% for cardiovascular, from 1.6% to 1.3% for organisational, from 0.9% to 0.7% for general, and from 1.1% to 0.7% for respiratory incidents. The occurrence of intraoperative adverse events in ambulatory anaesthesia has continuously decreased between 2000 and 2016. This trend is essentially attributable to a reduction in the incidence of technical, cardiovascular and organisational events. &nbsp.

Topical anaesthesia plus intracameral lidocaine versus topical anaesthesia alone for phacoemulsification cataract surgery in adults.

Topical anaesthesia plus intracameral lidocaine versus topical anaesthesia alone for phacoemulsification cataract surgery in adults.

Adverse events associated with gender affirming vaginoplasty surgery

There is an abundance of reports on the surgical techniques for vaginoplasty surgery. However, careful review reveals a paucity of evidence-based data in addition to few reports on outcomes related to all of the varying techniques. This study aimed to describe the perioperative adverse events related to vaginoplasty surgery for transgender women and to determine a threshold case number needed to reduce adverse events. This was a retrospective study of all women who underwent vaginoplasty surgery for gender affirmation at a tertiary care center. All cases were performed by a single board-certified female pelvic medicine and reconstructive surgery specialist. Women were included if 6-month outcomes were available. Once patients were identified, perioperative data were collected. Comparisons of adverse events and perioperative outcomes were made between varying threshold case numbers to determine the case number needed to significantly reduce adverse events. An a priori review of the literature was done to determine the incidence of commonly reported adverse events, and these incidences were used as a frame of reference to determine a threshold case number needed to replicate these reported incidence rates. Once this threshold was determined, outcomes were compared between cases performed before and after this threshold. Between December 2015 and March 2019, 76 vaginoplasty surgeries were performed. Six-month outcomes data were available for all patients. Mean age and body mass index of all patients were 41 (±17) years and 27.3 (±5.1) kg/m2, respectively. Median (range) time on hormone therapy preceding surgery was 36 (12-360) months, and 7.9% (6) of patients had undergone previous orchiectomy. Of the patients, 83.4% (71) underwent full-depth vaginoplasty, whereas the remaining patients underwent a zero-depth procedure. Median (range) surgical time was 210 (138-362) minutes. Median (range) follow-up for all patients was 12.5 (6-50) months. The incidence of any intraoperative adverse event was 2.6% (95% confidence interval, 1.8-4.1) for all patients, whereas the incidence of any immediate (<30 days) and delayed (>30 days and <6 months) postoperative event was 19% (95% confidence interval, 16.4-22.2) and 25% (95% confidence interval, 22.4-28.4), respectively. Performance of 50 cases was identified to be a threshold that reduced adverse events in both clinically and statistically significant ways. Cases performed after the first 50 cases had lower surgical times (187 (138-224) vs 240 (162-362) minutes, P<.0001), a lower incidence of delayed postoperative adverse events (15.4% vs 36%, P=.007), including a lower incidence of urinary stream abnormalities, introital stenosis, and the need for revision surgery. The incidence of intraoperative and immediate adverse events was not different between the groups. The incidence of serious adverse events related to vaginoplasty surgery is low, whereas minor events are common. After a threshold of 50 vaginoplasty surgeries, these events were reduced, including the need for revision surgery.

09: Adverse events associated with gender affirming vaginoplasty surgery

To describe perioperative adverse events related to vaginoplasty surgery for transgender women and to determine a threshold case number needed to reduce adverse events. This was a retrospective study of all women who underwent vaginoplasty at a tertiary care center. Women were included if 6-month outcomes were available. Once patients were identified, perioperative data were collected. Comparisons of adverse events and perioperative outcomes were made between varying threshold case numbers to determine the case number needed to significantly reduce adverse events. Once this threshold was determined, outcomes were compared between cases performed before and after this threshold. Between December 2015 and March 2019, 76 vaginoplasty cases were performed. Mean age and BMI were 41 (±17) and 27.3 (±5.1). Of the patients, 83.4% (71) underwent full depth vaginoplasty while remaining patients underwent a zero-depth procedure. Median surgical time was 210 (138-362) minutes. Median follow-up was 12.5 (6-50) months. The incidence of any intraoperative adverse event was 2.6% (95% CI 1.8, 4.1) while the incidence of any immediate (<30 days) and delayed (>30 days) postoperative event was 19% (95% CI 16.4, 22.2) and 25% (95% CI 22.4, 28.4). A threshold of 50 cases was determined to be necessary to reduce adverse events in a clinically and statistically significant way. Cases performed after the first 50 cases had lower surgical times: 240 (162-362) vs 187 (138-224) minutes, p < 0.0001 and a lower incidence of delayed postoperative events: 15.4% vs 36%, p = 0.007, with a lower incidence of urinary stream abnormalities, introital stenosis and need for revision surgery. The incidence of intraoperative and immediate adverse events was not different between groups. The incidence of serious adverse events related to vaginoplasty surgery is low while minor events are common. A threshold of 50 vaginoplasty cases is necessary to reduce delayed events including the need for revision surgery.

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.

Surgical results of third or more cardiac valve operation.

BackgroundWe evaluated operative outcomes after third or more cardiac operations for valvular heart disease, and analyzed whether pericardial coverage with artificial membrane is helpful for subsequent reoperation.MethodsFrom 2000 to 2012, 149 patients (male: female=70: 79; mean age at operation, 57.0±11.3 years) underwent their third to fifth operations for valvular heart disease. Early results were compared between patients who underwent their third operation (n=114) and those who underwent fourth or fifth operation (n=35). Outcomes were also compared between 71 patients who had their pericardium open during the previous operation and 27 patients who had artificial membrane coverage.ResultsIntraoperative adverse events occurred in 22 patients (14.8%). Right atrium (n=6) and innominate vein (n=5) were most frequently injured. In-hospital mortality rate was 9.4%. Total cardiopulmonary bypass time (225±77 minutes vs. 287±134 minutes, p=0.012) and the time required to prepare aortic cross clamp (209±57 minutes vs. 259±68 minutes, p<0.001) increased as reoperations were repeated. However, intraoperative event rate (13.2% vs. 20.0%), in-hospital mortality (9.6% vs. 8.6%) and postoperative complications were not statistically different according to the number of previous operations. Pericardial closure using artificial membrane at previous operation was not beneficial in reducing intraoperative events (25.9% vs. 18.3%) and shortening operation time preparing aortic cross clamp (248±64 minutes vs. 225±59 minutes) as compared to no-closure.ConclusionClinical outcomes of the third or more operations for valvular heart disease were acceptable in terms of intraoperative adverse events and in-hospital mortality rates. There were no differences in the incidence of intraoperative adverse events, early mortality and postoperative complications between third cardiac operation and fourth or more.

Intraoperative Adverse Events and Related Postoperative Complications in Spine Surgery: Implications for Enhancing Patient Safety Founded on Evidence-Based Protocols

Prospective observational study. To assess the incidence and clinical consequence of intraoperative adverse events from a wide variety of spinal surgical procedures. In this study, adverse events were defined as any unexpected or undesirable event(s) occurring as a result of spinal surgery. A complication was defined as a disease or disorder, which, as a consequence of a surgical procedure, will negatively affect the outcome of the patient. We hypothesized that most adverse events would not result in complications that would be normally flagged through traditional practice audit approaches. By defining the incidence and types of adverse events seen in a spine surgical practice, we hope to develop preventative approaches to enhance patient safety. All postoperative clinical sequelae (i.e., complications) were prospectively identified, classified as to type, and graded (0 [none] to IV [death]) in 700 consecutive patients who underwent spine surgery (excluding > 300-day surgery microdiscectomies) at a university center from January 2002 to June 2003. To confirm data accuracy and assess the clinical sequelae of any adverse events, the medical records of these 700 patients were reviewed. The overall incidence of intraoperative adverse events was 14% (98/700). A total of 23 adverse events led to postoperative clinical sequelae for an overall intraoperative complication incidence of 3.2% (23/700). Specific adverse events included dural tears (n = 58), spinal instrumentation-related events (n = 12), blood loss exceeding 5000 mL (n = 10), anesthesia/medical (n = 4), suspected or actual vertebral artery injury (n = 3), approach-related events (n = 3), esophageal/pharyngeal injury (n = 2), and miscellaneous (n = 6). Adverse events can frequently occur (14%) during spinal surgery, however, the majority (76.5%) are not associated with complications. Improved patient safety can only be maximized by independent practice audit and the development of prospective methods to record adverse event data so that enhanced, evidence-based, clinical protocols can be developed.