Dataset Information

Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study.

ABSTRACT: We investigated whether a fibrinogen-thrombin collagen sponge patch reduces postoperative complications of parotid gland surgery. This single-blinded, randomized controlled study included 165 patients who underwent parotid surgery for benign tumors (2018-2019) at a tertiary center. Primary outcomes were postoperative drain amount, days until drain removal, and discharge. Patients were scheduled for follow-up at 1 and 4 weeks, and 3 months after surgery. Complications including surgical site infection, pain, seroma, sialocele, salivary fistula, facial nerve palsy, Frey's syndrome with subjective symptoms, and facial asymmetry were analyzed. After identifying confounding variables, multivariate approaches were used. Histologic analysis was performed in a mouse model of salivary gland surgery. In total, 162 patients (77, fibrinogen-thrombin collagen patch group; 85, controls) were included, with no significant between-group differences other than resected tissue. Among postoperative total drain amount and days until drain removal and discharge, the only postoperative total drain was significantly lower in the patch group than in the control group in the adjusted model. Additionally, although validation through robust trials with longer follow-up is needed, we found the potential benefit of the fibrinogen patch on Frey's syndrome and facial asymmetry. In conclusion, fibrinogen-thrombin-impregnated collagen patches in parotidectomy can reduce postoperative drainage and improve outcomes.

SUBMITTER: Song K

PROVIDER: S-EPMC8836986 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study.

Song Kunho K Oh Chan C Won Ho-Ryun HR Koo Bon Seok BS Kim Da Mi DM Yeo Min-Kyung MK Choi Yujin Y Chang Jae Won JW

Journal of clinical medicine 20220129 3

We investigated whether a fibrinogen-thrombin collagen sponge patch reduces postoperative complications of parotid gland surgery. This single-blinded, randomized controlled study included 165 patients who underwent parotid surgery for benign tumors (2018-2019) at a tertiary center. Primary outcomes were postoperative drain amount, days until drain removal, and discharge. Patients were scheduled for follow-up at 1 and 4 weeks, and 3 months after surgery. Complications including surgical site infe ...[more]

PMID: 35160200

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Project description:BackgroundParotidectomy is a common treatment option for parotid neoplasms and the complications associated with this procedure can cause significant morbidity. Reconstruction following parotidectomy is utilized to address contour deformity and facial nerve paralysis. This study aims to demonstrate national trends in parotidectomy patients and identify factors associated with adverse postoperative outcomes. This study includes the largest patient database to date in determining epidemiologic trends, reconstructive trends, and prevalence of adverse events following parotidectomy.MethodsA retrospective review was performed for parotidectomies included in the ACS-NSQIP database between January 2012 and December 2017. CPT codes were used to identify the primary and secondary procedures performed. Univariate and multivariate analysis was utilized to determine associations between pre- and perioperative variables with patient outcomes. Preoperative demographics, surgical indications, and common medical comorbidities were collected. CPT codes were used to identify patients who underwent parotidectomy with or without reconstruction. These pre- and perioperative characteristics were compared with 30-day surgical complications, medical complications, reoperation, and readmission using uni- and multivariate analyses to determine predictors of adverse events.ResultsThere were 11,057 patients who underwent parotidectomy. Postoperative complications within 30 days were uncommon (1.7% medical, 3.8% surgical), with the majority of these being surgical site infection (2.7%). Free flap reconstruction, COPD, bleeding disorders, smoking, and presence of malignant tumor were the strongest independent predictors of surgical site infection. Readmission and reoperation were uncommon at an incidence of 2.1% each. The strongest factors predictive of readmission were malignant tumor and corticosteroid usage. The strongest factors predictive of reoperation were free flap reconstruction, malignant tumor, bleeding disorder, and disseminated cancer. Surgical volume/contour reconstruction was relatively uncommon (18%). Facial nerve sacrifice was uncommon (3.7%) and, of these cases, only 25.5% underwent facial nerve reinnervation and 24.0% underwent facial reanimation.ConclusionsThere are overall low rates of complications, readmissions, and reoperations following parotidectomy. However, certain factors are predictive of adverse postoperative events and this data may serve to guide management and counseling of patients undergoing parotidectomy. Concurrent reconstructive procedures are not commonly reported which may be due to underutilization or underreporting.

Project description:ObjectiveTo identify, appraise, and synthesise the best available evidence on the efficacy of perioperative interventions to reduce postoperative pulmonary complications (PPCs) in adult patients undergoing non-cardiac surgery.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesMedline, Embase, CINHAL, and CENTRAL from January 1990 to December 2017.Eligibility criteriaRandomised controlled trials investigating short term, protocolised medical interventions conducted before, during, or after non-cardiac surgery were included. Trials with clinical diagnostic criteria for PPC outcomes were included. Studies of surgical technique or physiological or biochemical outcomes were excluded.Data extraction and synthesisReviewers independently identified studies, extracted data, and assessed the quality of evidence. Meta-analyses were conducted to calculate risk ratios with 95% confidence intervals. Quality of evidence was summarised in accordance with GRADE methods. The primary outcome was the incidence of PPCs. Secondary outcomes were respiratory infection, atelectasis, length of hospital stay, and mortality. Trial sequential analysis was used to investigate the reliability and conclusiveness of available evidence. Adverse effects of interventions were not measured or compared.Results117 trials enrolled 21 940 participants, investigating 11 categories of intervention. 95 randomised controlled trials enrolling 18 062 participants were included in meta-analysis; 22 trials were excluded from meta-analysis because the interventions were not sufficiently similar to be pooled. No high quality evidence was found for interventions to reduce the primary outcome (incidence of PPCs). Seven interventions had low or moderate quality evidence with confidence intervals indicating a probable reduction in PPCs: enhanced recovery pathways (risk ratio 0.35, 95% confidence interval 0.21 to 0.58), prophylactic mucolytics (0.40, 0.23 to 0.67), postoperative continuous positive airway pressure ventilation (0.49, 0.24 to 0.99), lung protective intraoperative ventilation (0.52, 0.30 to 0.88), prophylactic respiratory physiotherapy (0.55, 0.32 to 0.93), epidural analgesia (0.77, 0.65 to 0.92), and goal directed haemodynamic therapy (0.87, 0.77 to 0.98). Moderate quality evidence showed no benefit for incentive spirometry in preventing PPCs. Trial sequential analysis adjustment confidently supported a relative risk reduction of 25% in PPCs for prophylactic respiratory physiotherapy, epidural analgesia, enhanced recovery pathways, and goal directed haemodynamic therapies. Insufficient data were available to support or refute equivalent relative risk reductions for other interventions.ConclusionsPredominantly low quality evidence favours multiple perioperative PPC reduction strategies. Clinicians may choose to reassess their perioperative care pathways, but the results indicate that new trials with a low risk of bias are needed to obtain conclusive evidence of efficacy for many of these interventions.Study registrationProspero CRD42016035662.

Project description:BackgroundThe potential of haemostatic patches to reduce the rate of postoperative pancreatic fistula remains unclear. The aim of this trial was to evaluate the impact of a polyethylene glycol-coated haemostatic patch on the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy.MethodsIn this randomized, single-centre, clinical trial, patients undergoing pancreatoduodenectomy were randomized 1 : 1 to receive pancreatojejunostomy reinforced with two polyethylene glycol-coated haemostatic patches (patch group) or without any reinforcement (control group). The primary outcome was clinically relevant postoperative pancreatic fistula, defined as grade B/C according to International Study Group of Pancreatic Surgery criteria, within 90 days. Key secondary outcomes were length of hospital stay, total rate of postoperative pancreatic fistula, and overall complication rate.ResultsFrom 15 May 2018 to 22 June 2020, 72 patients were randomized, and 64 were included in the analyses (31 in the patch group and 33 in the control group). The risk of clinically relevant postoperative pancreatic fistula was reduced by 90 per cent (OR 0.10, 95 per cent c.i. 0.01 to 0.89, P = 0.039). Moreover, the use of the polyethylene glycol-coated patch retained its protective effect on clinically relevant postoperative pancreatic fistula in a multivariable regression model, significantly reducing the risk of clinically relevant postoperative pancreatic fistula by 93 per cent (OR 0.07, 95 per cent c.i. 0.01 to 0.67, P = 0.021), regardless of patient age, sex, or fistula risk score. The incidence of secondary outcomes did not significantly differ between the groups. One patient died within 90 days in the patch group versus three patients in the control group.ConclusionsA polyethylene glycol-coated haemostatic patch reduced the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy.Registration numberNCT03419676 (http://www.clinicaltrials.gov).

Dataset Information

Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study.

Publications

Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study.

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