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A randomized, multicenter trial that compared endovascular repair with open repair of abdominal aortic aneurysm showed no significant difference between these approaches in overall survival after 8 years.

AbstractObjectiveTo assess whether a clinically relevant difference exists in patients’ perceptions of symptoms, knee function, and ability to participate in sports over a period of two years after rupture of the anterior cruciate ligament (ACL) between two commonly used treatment regimens.DesignOpen labelled, multicentre, parallel randomised controlled trial (COMPARE).SettingSix hospitals in the Netherlands, between May 2011 and April 2016.ParticipantsPatients aged 18 to 65 with an acute rupture of the ACL, recruited from six hospitals. Patients were evaluated at three, six, nine, 12, and 24 months.Interventions85 patients were randomised to early ACL reconstruction and 82 to rehabilitation followed by optional delayed ACL reconstruction after a three month period (primary non-operative treatment).Main outcomesPatients’ perceptions of symptoms, knee function, and ability to participate in sporting activities were assessed with the International Knee Documentation Committee score (optimum score 100) at each time point over 24 months.ResultsBetween May 2011 and April 2016, 167 patients were enrolled in the study and randomised to one of two treatments (mean age 31.3; 67 (40.%) women), and 163 (98%) completed the trial. In the rehabilitation and optional delayed ACL reconstruction group, 41 (50%) patients underwent reconstruction during follow-up. After 24 months, the early ACL reconstruction group had a significantly better (P=0.026) but not clinically relevant International Knee Documentation Committee score (84.7 v 79.4 (difference between groups 5.3, 95% confidence interval 0.6 to 9.9). After three months of follow-up, the International Knee Documentation Committee score was significantly better (P=0.002) for the rehabilitation and optional delayed ACL reconstruction group (difference between groups −9.3, −14.6 to −4.0). After nine months of follow-up, the difference in the International Knee Documentation Committee score changed in favour of the early ACL reconstruction group. After 12 months, differences between the groups were smaller. In the early ACL reconstruction group, four re-ruptures and three ruptures of the contralateral ACL occurred during follow-up versus two re-ruptures and one rupture of the contralateral ACL in the rehabilitation and optional delayed ACL reconstruction group.ConclusionsIn patients with acute rupture of the ACL, those who underwent early surgical reconstruction, compared with rehabilitation followed by elective surgical reconstruction, had improved perceptions of symptoms, knee function, and ability to participate in sports at the two year follow-up. This finding was significant (P=0.026) but the clinical importance is unclear. Interpretation of the results of the study should consider that 50% of the patients randomised to the rehabilitation group did not need surgical reconstruction.Trial registrationNetherlands Trial Register NL 2618.

Background Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours. Methods We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials. Results Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 ( p  = 0.18), and DFS HR = 0.66 ( p  = 0.04). Corresponding per-protocol results were: OS HR = 0.59 ( p  = 0.054), and DFS HR = 0.56 ( p  = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 ( p  < 0.001). Conclusion SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours. Clinical Trial Registration NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.

Background Approximately 20% to 30% of patients awaiting cardiac surgery are anemic. Anemia increases the likelihood of requiring a red cell transfusion and is associated with increased complications, intensive care, and hospital stay following surgery. Iron deficiency is the commonest cause of anemia and preoperative intravenous (IV) iron therapy thus may improve anemia and therefore patient outcome following cardiac surgery. We have initiated the intravenous iron for treatment of anemia before cardiac surgery (ITACS) Trial to test the hypothesis that in patients with anemia awaiting elective cardiac surgery, IV iron will reduce complications, and facilitate recovery after surgery. Methods ITACS is a 1,000 patient, international randomized trial in patients with anemia undergoing elective cardiac surgery. The patients, health care providers, data collectors, and statistician are blinded to whether patients receive IV iron 1,000 mg, or placebo, at 1-26 weeks before their planned date of surgery. The primary endpoint is the number of days alive and at home up to 90 days after surgery. Results To date, ITACS has enrolled 615 patients in 30 hospitals in 9 countries. Patient mean (SD) age is 66 (12) years, 63% are male, with a mean (SD) hemoglobin at baseline of 118 (12) g/L; 40% have evidence (ferritin <100 ng/mL and/or transferrin saturation <25%) suggestive of iron deficiency. Most (59%) patients have undergone coronary artery surgery with or without valve surgery. Conclusions The ITACS Trial will be the largest study yet conducted to ascertain the benefits and risks of IV iron administration in anemic patients awaiting cardiac surgery.

This study determined whether a one-hour music intervention while patients were in the post-anesthesia care unit (PACU) could improve postoperative recovery for female patients. Single-center, prospective, randomized controlled trial. Tertiary university hospital in China. 194 females aged 18–65 years scheduled for laparoscopic gynecological surgical procedures under general anesthesia. Patients were randomly assigned to receive therapist-selected music through earphones or wore earphones without listening to music. The primary outcome was State-Trait Anxiety Inventory (STAI; STAI-S and STAI-T subscales) scores. Secondary outcomes included post-operative quality recovery scale (PQRS) scores and other scales assessing pain and sleep quality, as well as serum glucose, lactate, and stress hormones levels, including adrenocorticotropic hormone (ACTH), cortical hormone releasing hormone (CRH), cortisol, and aldosterone. Results from 188 patients were analyzed. Participants in both music and control groups had decreased STAI-S scores on the first and second postoperative days. The music group had a greater reduction in STAI-S scores than the control group (P < 0.001). The music group also had reduced agitation, pain intensity, and reliance on analgesics, as well as improved sleep quality compared to the control group. The control group had higher ACTH levels (P = 0.03) and cortisol levels (P = 0.003) than the music group. CRH, aldosterone, blood glucose, and lactate concentrations did not significantly differ between groups. Music intervention in PACU for female patients undergoing elective laparoscopic gynecological surgery under general anesthesia helped alleviate postoperative anxiety and enhanced the quality of postoperative recovery. [Display omitted] •Studies on the effects of music intervention in PACU on postoperative recovery are rare.•One-hour music intervention in PACU alleviated patient postoperative discomfort.•One-hour music intervention in PACU could be applied to improve the postoperative recovery quality in female patients.

Background The recent guidelines from the European and American Hernia Societies recommend a continuous small-bite suturing technique with slowly absorbable sutures for fascial closure of midline abdominal wall incisions to reduce the incidence of wound complications, especially for incisional hernia. However, this is based on low-certainty evidence. We could not find any recommendations for skin closure. The wound closure technique is an important determinant of the risk of wound complications, and a comprehensive approach to prevent wound complications should be developed. Methods We propose a single-institute, prospective, randomized, blinded-endpoint trial to assess the superiority of the combination of continuous suturing of the fascia without peritoneal closure and continuous suturing of the subcuticular tissue (study group) over that of interrupted suturing of the fascia together with the peritoneum and interrupted suturing of the subcuticular tissue (control group) for reducing the incidence of midline abdominal wall incision wound complications after elective gastroenterological surgery with a clean-contaminated wound. Permuted-block randomization with an allocation ratio of 1:1 and blocking will be used. We hypothesize that the study group will show a 50% reduction in the incidence of wound complications. The target number of cases is set at 284. The primary outcome is the incidence of wound complications, including incisional surgical site infection, hemorrhage, seroma, wound dehiscence within 30 days after surgery, and incisional hernia at approximately 1 year after surgery. Discussion This trial will provide initial evidence on the ideal combination of fascial and skin closure for midline abdominal wall incision to reduce the incidence of overall postoperative wound complications after gastroenterological surgery with a clean-contaminated wound. This trial is expected to generate high-quality evidence that supports the current guidelines for the closure of abdominal wall incisions from the European and American Hernia Societies and to contribute to their next updates. Trial registration UMIN-CTR UMIN000048442. Registered on 1 August 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205

IntroductionIn moderate to high-risk surgical procedures, 15–25% of patients develop a postoperative surgical site infection. Intraoperative incisional wound irrigation has the potential to reduce surgical site infections, and additional randomised controlled trials are required to provide evidence of effectiveness.Methods and analysisThis protocol describes a pragmatic, adaptive, participant and adjudicator-blinded trial at 13 sites in Canada in up to 2500 participants. Participants planned for surgery with an abdominal or groin incision, who are eligible and provide verbal consent through an integrated consent model, are randomised to receive intraoperative incisional wound irrigation with povidone-iodine, saline or no irrigation. The primary outcome is surgical site infection within 30 days postoperatively. Secondary outcomes include quality of life measured 30 days postoperatively and morbidity, mortality and healthcare utilisation within 90 days postoperatively.Ethics and disseminationThis trial has been approved by the research ethics board at the participating centres and stopped enrolling participants on May 23, 2025. All participants will provide verbal consent. Results will be disseminated via presentation at conferences, publication and posted on clinicaltrials.gov.Trial registration numberThe study is registered with http://clinicaltrial.gov (NCT04548661; 14 September 2020).

Postoperative delirium was reported to be associated with increased postoperative mortality after liver resection. Therefore, it is crucial to prevent postoperative delirium in such cases. Ramelteon, an agonist of melatonin receptor has been suggested to be useful for preventing delirium. The aim of this study was to examine whether ramelteon is effective at preventing delirium after elective liver resection. The cases of patients who underwent liver resection at Nara Medical University (Nara, Japan) between January 2014 and August 2018 were analyzed. During the period from January 2017 to August 2018, ramelteon was prospectively administered to patients who underwent liver resection [8 mg/day on the day before surgery and on postoperative days 1 to 3] (ramelteon group), whereas ramelteon was not administered during the period from January 2014 to December 2016 (control group). The perioperative outcomes of the two groups were compared. There were 120 patients in the ramelteon group and 186 patients in the control group. No significant intergroup differences in background factors, including age, gender, and preoperative serological laboratory data, were detected. The incidence of postoperative delirium was significantly lower in the ramelteon group (5.8% vs. 15.1%, P = 0.035). Multivariate analysis revealed that being aged ≥75 (P = 0.002), being male (P = 0.020), cardiovascular disease (P = 0.023), blood loss ≥1000ml (P = 0.001) and the absence of ramelteon treatment (P = 0.046) were independent risk factors for postoperative delirium. The administration of ramelteon might reduce the risk of postoperative delirium after elective liver resection.

BackgroundIntraperitoneal isotonic saline instillation (SI) and pulmonary recruitment maneuver (RM) were indicated to alleviate post-laparoscopic shoulder pain (PLSP) effectively. The aim of this study was to compare the effects of the single strategy using SI alone and the combined strategy using SI and RM on PLSP reduction.MethodsSubjects undergoing elective gynecologic laparoscopy were randomly allocated to a control group (no intervention, n = 48) and two intervention groups (single strategy of SI alone, n = 48; combined strategy of SI and RM, n = 48). In the control group, carbon dioxide was removed only via passive evacuation through the port sites at the completion of the laparoscopic procedure. In the saline instillation group, 20-mL/kg of body weight SI was performed. In the combined strategy group, RM using five pulmonary inflations was performed, in addition to SI. The PLSP scores, which were the primary outcome, were recorded using a visual analog scale postoperatively.ResultsThe PLSP scores 24 and 48 h after surgery were significantly lower in the two intervention groups than in the control group (P = 0.014 and P = 0.001, respectively), while no significant differences were observed between the two intervention groups.ConclusionsThe single strategy using SI alone is as effective as the combined strategy of SI and RM for removing residual carbon dioxide and consequently preventing PLSP. Therefore, considering the potential risks of pulmonary or hemodynamic complications associated with RM, the single strategy using SI alone might be a better choice than the combined strategy.

Hypotension after induction of general anesthesia (GAIH) is common and is associated with postoperative complications including increased mortality. Collapsibility of the inferior vena cava (IVC) has good performance in predicting GAIH; however, there is limited evidence whether a preoperative fluid bolus in patients with a collapsible IVC can prevent this drop in blood pressure. We conducted a single-centre randomized controlled trial with adult patients scheduled to undergo elective noncardiac surgery under general anesthesia (GA). Patients underwent a preoperative point-of-care ultrasound scan (POCUS) to identify those with a collapsible IVC (IVC collapsibility index ≥ 43%). Individuals with a collapsible IVC were randomized to receive a preoperative 500 mL fluid bolus or routine care (control group). Surgical and anesthesia teams were blinded to the results of the scan and group allocation. Hypotension after induction of GA was defined as the use of vasopressors/inotropes or a decrease in mean arterial pressure < 65 mm Hg or > 25% from baseline within 20 min of induction of GA. Forty patients (20 in each group) were included. The rate of hypotension after induction of GA was significantly reduced in those receiving preoperative fluids (9/20, 45% vs 17/20, 85%; relative risk, 0.53; 95% confidence interval, 0.32 to 0.89; P = 0.02). The mean (standard deviation) time to complete POCUS was 4 (2) min, and the duration of fluid bolus administration was 14 (5) min. Neither surgical delays nor adverse events occurred as a result of the study intervention. A preoperative fluid bolus in patients with a collapsible IVC reduced the incidence of GAIH without associated adverse effects. ClinicalTrials.gov (NCT05424510); first submitted 15 June 2022.