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Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events.

ABSTRACT: BACKGROUND:Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy (PPV) under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients with an interruption in this therapy before surgery. METHODS:Ninety-six patients will be randomly assigned to either the control group, in whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group in whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed up for 12?weeks, and the primary outcome, and haemorrhagic complications until 15?days after surgery, will be evaluated. DISCUSSION:This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy. TRIAL REGISTRATION:Clinical Trials Register EudraCT, 2018-000753-45. Registered on 11 November 2018.

SUBMITTER: Andonegui J

PROVIDER: S-EPMC6894279 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events.

Andonegui Jose J Capdevila Ferran F Zubicoa Alicia A Ibáñez Berta B

Trials 20191204 1

<h4>Background</h4>Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation o ...[more]

PMID: 31801597

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Project description:BackgroundA direct comparison of severe acute respiratory syndrome coronavirus 2 positive patients with a severe acute respiratory syndrome coronavirus 2 negative control group undergoing an operative intervention during the current pandemic is lacking, and a reliable estimate of the assumed difference in morbidity and mortality between both patient categories remains unknown.MethodsWe included all consecutive patients with a confirmed pre- or postoperative severe acute respiratory syndrome coronavirus 2 positive status (operated in 27 hospitals) and negative control patients (operated in 4 hospitals) undergoing emergency or elective operations. A propensity score-matched comparison of clinical outcomes was performed between severe acute respiratory syndrome coronavirus 2 positive and negative tested patients (control group). Primary outcome was overall 30-day mortality rate between both groups. Main secondary outcomes were overall, pulmonary, and thromboembolic complications.ResultsIn total, 161 severe acute respiratory syndrome coronavirus 2 positive and 342 control severe acute respiratory syndrome coronavirus 2 negative patients were included in this study. The 30-day overall postoperative mortality rate was greater in the severe acute respiratory syndrome coronavirus 2 positive cohort compared with the negative control group (16% vs 4% respectively; P = .007). After propensity score matching, the severe acute respiratory syndrome coronavirus 2 positive group consisted of 123 patients (median 70 years of age [interquartile range 59-77] and 55% male) were compared with 196 patients in the matched control group (median 69 years (interquartile range 58-75] and 53% male). The 30-day mortality rate and risk were greater in the severe acute respiratory syndrome coronavirus 2 positive group compared with the matched control group (12% vs 4%; P = .009 and odds ratio 3.4 [95% confidence interval 1.5-8.5]; P = .005, respectively). Overall, pulmonary and thromboembolic complications occurred more often in severe acute respiratory syndrome coronavirus 2 positive patients (P < .01).ConclusionPatients diagnosed with perioperative severe acute respiratory syndrome coronavirus 2 have an increased risk of 30-day mortality, pulmonary complications, and thromboembolic events. These findings serve as an evidence-based argument to postpone elective surgery and selected emergency cases.

Project description:BackgroundPre-emptive local analgesia with the use of lidocaine is practised increasingly in veterinary medicine as part of applied multimodal analgesia, despite its controversial impact on wound healing. The purpose of this prospective, randomised, double-blinded, placebo-controlled clinical study was to evaluate if preoperative subcutaneous infiltration of lidocaine has a negative impact on primary wound healing of surgical incisions. Fifty-two companion animals (3 cats and 49 dogs) were enrolled in the study. The inclusion criteria were as follows: American Society of Anaesthesiologists (ASA) score I or II, a minimum body weight of 5 kg, and a planned incisional length of at least 4 cm. Surgical incisions were infiltrated subcutaneously with lidocaine without adrenaline or NaCl (placebo). Follow-up questionnaires for owners and veterinarians and thermography of the surgical wound were used to assess wound healing. Antimicrobial use was documented.ResultsThere was no significant difference in either the total score or the individual assessment points between the treatment and the placebo group on the owner or the veterinary questionnaires in regard to primary wound healing (P > 0.05 for all comparisons). No significant difference was found between the thermography results of the treatment and placebo group (P = 0.78), and there was no significant correlation between the total score from the veterinary protocol and thermography results (Spearman's correlation coefficient - 0.10, P = 0.51). Surgical site infections developed in 5/53 (9.4%) surgeries and its occurrence varied significantly between the treatment and the placebo group as all cases of infection were in the placebo group (P = 0.05).ConclusionThe results of this study indicate that lidocaine used as a local anaesthetic did not affect wound healing in patients with ASA scores I-II. The results suggest that lidocaine infiltration in surgical incisions can be safely used to reduce pain.

Project description:ObjectiveEvaluate the feasibility of a trial of perioperative hypotension and serious complications.DesignA patient and assessor-blinded randomised feasibility trial.SettingWe included patients in a tertiary university hospital.ParticipantsWe enrolled 80 adults scheduled for major non-cardiac surgery.InterventionsIn patients randomised to tight blood pressure control, intraoperative mean arterial pressure (MAP) was targeted to ≥85 mm Hg maintained with norepinephrine infusion, and restarting chronic antihypertensive medications was delayed until the third postoperative day. In the reference group, intraoperative blood pressure was managed per routine and antihypertensive medications were restarted immediately after surgery.Primary and secondary outcome measuresOur first co-primary outcome was the fraction of time when intraoperative MAP was >85 mm Hg, intraoperative area (time integral) of MAP >85 mm Hg and MAP <65 mm Hg. The second co-primary outcome was time until antihypertensive medications were restarted after surgery. Secondary outcomes were time-weighted average intraoperative MAP, cumulative minimum MAP for 10 min, average postoperative systolic blood pressure (SBP) and mean of the lowest three postoperative SBPs.ResultsForty patients in each group were analysed. The median for intraoperative area of MAP >85 mm Hg was 1303 (772-2419) mm Hg*min in routine blood pressure (BP) cases and 2425 (1926-3545) mm Hg*min in tight BP control. The area for intraoperative MAP <65 mm Hg was 7 (0-40) mm Hg*min with routine BP management, and 0 (0-0) mm Hg*min with tight BP control. The fraction of time with MAP >85 mm Hg was 0.52 (0.25) and 0.87 (0.15). Antihypertensive medications were restarted 2 (1-3) days later in tight BP control cases. However, postoperative SBPs were similar.ConclusionsTight BP management markedly increased intraoperative MAP and reduced the amount of hypotension. In contrast, delaying chronic antihypertensive medications had little effect on postoperative SBP. The full trial appears feasible and remains necessary but should not include postoperative antihypertensive management.Trial registrationNCT04789733.

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Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events.

Publications

Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events.

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