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Effect of intra-operative glove changing during cesarean section on post-operative complications: a randomized controlled trial.

ABSTRACT: PURPOSE:To compare the rates of wound-related complications among women undergoing a cesarean section when the surgical team used intra-operative glove changing versus usual care. METHODS:All women undergoing a cesarean section at a single, county hospital were randomized to usual care or intra-operative glove changing prior to abdominal closure. Participants were randomized at the time of decision for cesarean section; surgeons were not blinded to the randomization arm. The primary outcome was any wound-related complication, including wound hematoma, seroma, skin separation of at least 1 cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery. To detect a reduction in the primary outcome from 17% in the control group to 9% in the intervention group with 80% power, a total of 554 women (277 per group) were required. Secondary outcomes included other infectious complications including endometritis and other superficial or deep soft tissue infections. RESULTS:From August 2015 to November 2016, 277 women were randomized to usual care and 276 women were randomized to intra-operative glove changing. The two groups were well balanced in terms of demographic data, comorbid conditions and surgical characteristics. Intra-operative glove changing led to a significant decrease in composite wound complications from 13.6% in the control group to 6.4% in the intervention group (p?=?0.008). CONCLUSION:Intra-operative glove changing prior to abdominal closure during cesarean section significantly reduced the incidence of post-operative wound complications.

SUBMITTER: Scrafford JD

PROVIDER: S-EPMC5948161 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Effect of intra-operative glove changing during cesarean section on post-operative complications: a randomized controlled trial.

Scrafford Jonathan D JD Reddy Buvana B Rivard Colleen C Vogel Rachel Isaksson RI

Archives of gynecology and obstetrics 20180319 6

<h4>Purpose</h4>To compare the rates of wound-related complications among women undergoing a cesarean section when the surgical team used intra-operative glove changing versus usual care.<h4>Methods</h4>All women undergoing a cesarean section at a single, county hospital were randomized to usual care or intra-operative glove changing prior to abdominal closure. Participants were randomized at the time of decision for cesarean section; surgeons were not blinded to the randomization arm. The prima ...[more]

PMID: 29556706

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Project description:BackgroundNorepinephrine infusion decreases hypotension after spinal anesthesia during cesarean section. This study aimed to compare the efficacy of norepinephrine infusion and ephedrine bolus against post-spinal hypotension in parturients.MethodsIn this double-blinded, randomized controlled clinical trial, parturients scheduled for elective cesarean section were randomly allocated to receive norepinephrine infusion (0.05 μg·kg-1·min-1) just before spinal anesthesia continuing for 30 min or ephedrine bolus (0.15 mg/kg) just before spinal anesthesia. A rescue bolus (5 μg norepinephrine for the norepinephrine group, and 5 mg ephedrine for the ephedrine group) was administered whenever hypotension occurred. Our primary outcome was the incidence of hypotension within 30 min of spinal anesthesia administration. Secondary outcomes included maternal and neonatal outcomes 30 min after spinal block, and neonatal cerebral oxygenation 10 min after birth.ResultsIn total, 190 patients were enrolled; of these patients, 177 were included in the final analysis. Fewer patients suffered hypotension in the norepinephrine group than in the ephedrine group (29.5% vs. 44.9%, odds ratio [OR]: 0.51, 95% confidence interval [CI]: 0.28-0.95, P = 0.034). Moreover, the tachycardia frequency was lower in the norepinephrine group than in the ephedrine group (OR: 0.22, 95% CI: 0.11-0.44, P < 0.001), and patients suffered less nausea and vomiting (OR: 0.28, 95% CI: 0.11-0.70, P = 0.004). There was no difference in Apgar scores and umbilical arterial blood gas analysis between the two groups. However, neonatal cerebral regional saturations were significantly higher after birth in the norepinephrine group than in the ephedrine group (mean difference: 2.0%, 95% CI: 0.55%-3.45%, P = 0.008).ConclusionIn patients undergoing elective cesarean section with spinal anesthesia, norepinephrine infusion compared to ephedrine bolus resulted in less hypotension and tachycardia, and exhibited potential neonatal benefits.Trial registrationClinicalTrials.gov, NCT02542748; https://clinicaltrials.gov/ct2/show/record/NCT02542748.

Project description:Study objectiveTo assess whether different intensities of intra-abdominal pressure and deep neuromuscular blockade influence the risk of intra-operative surgical complications during laparoscopic donor nephrectomy.DesignA pooled analysis of ten previously performed prospective randomized controlled trials.SettingLaparoscopic donor nephrectomy performed in four academic hospitals in the Netherlands: Radboudumc, Leiden UMC, Erasmus MC Rotterdam, and Amsterdam UMC.PatientsFive hundred fifty-six patients undergoing a transperitoneal, fully laparoscopic donor nephrectomy enrolled in ten prospective, randomized controlled trials conducted in the Netherlands from 2001 to 2017.InterventionsModerate (tetanic count of four > 1) versus deep (post-tetanic count 1-5) neuromuscular blockade and standard (≥10 mmHg) versus low (<10 mmHg) intra-abdominal pressure.MeasurementsThe primary endpoint is the number of intra-operative surgical complications defined as any deviation from the ideal intra-operative course occurring between skin incision and closure with five severity grades, according to ClassIntra. Multiple logistic regression analyses were used to identify predictors of intra- and postoperative complications.Main resultsIn 53/556 (9.5%) patients, an intra-operative complication with ClassIntra grade ≥ 2 occurred. Multiple logistic regression analyses showed standard intra-abdominal pressure (OR 0.318, 95% CI 0.118-0.862; p = 0.024) as a predictor of less intra-operative complications and moderate neuromuscular blockade (OR 3.518, 95% CI 1.244-9.948; p = 0.018) as a predictor of more intra-operative complications. Postoperative complications occurred in 31/556 (6.8%), without significant predictors in multiple logistic regression analyses.ConclusionsOur data indicate that the use of deep neuromuscular blockade could increase safety during laparoscopic donor nephrectomy. Future randomized clinical trials should be performed to confirm this and to pursue whether it also applies to other types of laparoscopic surgery.Trial registrationClinicaltrials.gov LEOPARD-2 (NCT02146417), LEOPARD-3 trial (NCT02602964), and RELAX-1 study (NCT02838134), Klop et al. ( NTR 3096 ), Dols et al. 2014 ( NTR1433 ).

Project description:BackgroundLoss of resistance (LOR) technique is a widely used method to identify the epidural space. However, cases of inadequate epidural anesthesia in cesarean section were frequently reported. Also, the success rate of epidural anesthesia with LOR technique varied depending on the proficiency of the practitioner. The purpose of this study was to assess the efficacy and safety of electrical stimulation to identify epidural spaces in cesarean section for novices or clinicians with recent gap in experience.MethodsPregnant women scheduled for elective cesarean section were randomly allocated to two groups. Groups were classified based on the methods used for identifying the epidural space: the LOR group (group L) and the LOR with epidural electrical stimulation group (group E). Clinicians with less than 10 epidural cesarean section experiences in the recent year performed epidural anesthesia for cesarean section. In the group E, a RegionalStim® conductive catheter was inserted through the Tuohy needle, and the guidewire passing through the catheter was connected to a peripheral nerve stimulator. The intensity of the stimulation was gradually increased from 0.25 mA to 1.5 mA until paresthesia was elicited and radiated. We assessed the success of epidural anesthesia (complete success, partial success or failure). Other clinical parameters including maternal satisfaction, time required for epidural anesthesia, neonatal Apgar scores, pain scores and adverse events were compared between the two groups.ResultsExcept for 6 patients who withdrew consent, 54 patients were enrolled in this study (28 for the group L and 26 for the group E). The demographic data showed no difference between the two groups. There was no adverse event resulted from electrical stimulation. The group E showed higher rate of complete success, sensitivity in finding epidural space and maternal satisfaction compared to the group L (21/26 vs. 15/28, p = 0.034, 0.96 vs. 0.68, p = 0.012 and 4.04 vs. 3.39, p = 0.02, respectively). The other clinical parameters showed no differences between the two groups.ConclusionIn addition to the conventional LOR technique, identifying epidural spaces using electrical stimulation led to better outcomes without additional risks for novices as well as clinicians with recent gap in experience.Trial registrationThis study was retrospectively registered in the ClinicalTrials.gov Registry (NCT03443466) on February 23, 2018.

Project description:BackgroundVenous thromboembolism (VTE) is the most common preventable cause of 30-day post-operative mortality, with many events occurring after hospital discharge. High-level evidence supports post-discharge VTE chemoprophylaxis following abdominal/pelvic cancer resection; however, some studies support a more tailored approach. Our objectives were to (1) identify risk factors associated with post-discharge VTE in a large cohort of patients undergoing colorectal cancer resection and (2) develop a post-discharge VTE risk calculator.MethodsPatients who underwent colorectal cancer resection from 2012 to 2016 were identified from ACS NSQIP colectomy and proctectomy procedure-targeted modules. Multivariable logistic regression was used to identify factors associated with post-discharge VTE. Incorporating pre-operative, intra-operative, and post-operative variables, a post-discharge VTE risk calculator was constructed and validated.ResultsOf 51,139 patients, 387 (0.76%) developed post-discharge VTE. Pre-operative factors associated with post-discharge VTE included BMI (e.g., morbidly obese OR 2.27, 95% CI 1.65-3.12 vs. normal BMI), and thrombocytosis (OR 1.41, 95% CI 1.03-1.92). Intra-operative factors included operative time (4-6 h OR 1.56, 95% CI 1.12-2.17; > 6 h, OR 1.85, 95% CI 1.21-2.84, vs. < 2 h), and type of operation (e.g., open partial colectomy OR 1.67, 95% CI 1.30-2.16 vs. laparoscopic partial colectomy). Post-operative factors included anastomotic leak (OR 2.05, 95% CI 1.31-3.21) and post-operative ileus (OR 1.39, 95% CI 1.07-1.79). Using the risk calculator, the predicted probability of post-discharge VTE ranged from 0.04 to 10.29%. On a 10-fold cross validation, the calculator's mean C-Statistic was 0.65.ConclusionsPatient-specific factors are associated with varying rates of post-discharge VTE. We present the first post-discharge VTE risk calculator designed for use at the time of discharge following colorectal cancer resection.

Dataset Information

Effect of intra-operative glove changing during cesarean section on post-operative complications: a randomized controlled trial.

Publications

Effect of intra-operative glove changing during cesarean section on post-operative complications: a randomized controlled trial.

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