High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
ObjectivesTo systematically review the safety of harmonic scalpel and conventional resection in superficial parotidectomy.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) or cohort studies of harmonic scalpel and conventional resection in superficial parotidectomy from the inception of the database to December, 2018. Two reviewers independently screened literatures, extracted data and assessed risk of bias of the included studies. Then meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 10 studies involving 671 post-cesarean section patients (361 patients in harmonic scalpel group and 310 patients in conventional resection group) were included. The results of meta-analysis showed that: compared with conventional resection, harmonic scalpel had shorter operative time (MD=?23.82, 95%CI ?31.20 to ?16.44, P<0.000 01), less postoperative drain output (MD=?26.25, 95%CI ?38.95 to ?13.55, P<0.000 1), less intraoperative blood loss (MD=?23.78, 95%CI ?28.64 to ?18.91, P<0.000 01), shorter duration of hospital stay (MD=?1.19, 95%CI ?2.14 to ?0.23, P=0.02), and lower temporary facial nerve palsy rate (OR=0.27, 95%CI 0.14 to 0.50, P<0.000 1). However, there was no significant difference in the incidence of parotid gland leakage between two groups (OR=0.42, 95%CI 0.16 to 1.06, P=0.07).ConclusionsThe current evidence demonstrates that, compared to conventional resection, harmonic scalpel resection is safer. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Statistical graph is an indispensable part of scientific papers. It is helpful to promote the communication, dissemination, and application of academic achievements by presenting research results intuitively and accurately through standardized and beautiful visual graphs. The safety of a medical intervention is the basic premise of its clinical application, and randomized controlled trial (RCT) as an important design to determine the efficacy and safety of medical interventions, it is extremely important to accurately present the information on the safety outcomes of interventions found therein. However, the research found that the reports of RCTs didn’t adequately use visual graphs to present harms data. In order to promote clinical researchers to better use visual graphs to present harms data, international scholars recently published a consensus study in BMJ, which identified and recommended 10 statistical graphs for presenting harms data in RCTs. In order to facilitate domestic scholars to understand and apply the consensus, this article interprets the consensus and recommendations, and it is expected to provide help for improving the quality of harms visualization in domestic papers of RCTs.
Objective To compare the mean operative time and complications between the LigaSure device and Harmonic Scalpel during video-assisted endoscopic approaches thyroidectomy. Methods The clinical data of 684 cases performed Miccoli thyroidectomy by the same operation team from January 2007 to December 2011 in the department of general surgery，Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University were analyzed. Three hundred and forty-nine patients were used Harmonic Scalpel，335 patients were used LigaSure device. The mean operative time and complications （such as hematoma，transient hoarseness，permanent recurrent laryngeal nerve injury，and hypocalcemia） were compared between two groups. Results A total of 684 patients were included in the study，of whom 263 underwent total thyroidectomy and 421 underwent lobectomy. There were not significant differences of the operative time and the complications in both thyroidectomy and lobectomy between the LigaSure device and Harmonic Scalpel（P＞0.05）. Conclusions The uses of the LigaSure device and Harmonic Scalpel in thyroid surgery are safe and reliable，surgeons may choose surgical instruments by habits and medical equipments.
Building a harmonious socialist society reflects the inherent requirement of building a prosperous, democratic, civilized and harmonious modern socialist country. Strengthening medical and health services, and improving the level of people's health is one of the most important measures in constructing a socialist harmonious society of the CPC Central committee. Hospital is an important part of medical and health services. Hospital trade union is the bridge and link between the party and workers. Therefore, hospital trade union should give full play to its function and role, actively participate and promote the construction of harmonious hospital. The current hospital trade unions need positioned and explored under the present situation.
Objective
To evaluate the clinical effects of harmonic scalpel application in thoracoscopic surgery for lung cancer, which may guide its reasonable application.
Methods
We retrospectively analyzed the clinical data of 145 lung cancer patients receiving thoracoscopic surgery from January to March 2017 in our hospital. There were 57 patients with thoracoscopic pulmonary wedge resection, and harmonic scalpel was used in 34 patients (8 males, 26 females at age of 59.68±10.91 years), and was not used in 23 patients (13 males and 10 females at age of 59.13±11.21 years). There were 88 patients receiving thoracoscopic pulmonary lobectomy, among whom harmonic scalpel was used in 80 patients (36 males and 44 females at age of 59.68±10.91 years), and was not used in 8 patients (5 males, 3 females at age of 61.63±5.60 years). We recorded the perioperative outcomes of all patients.
Results
In the 34 patients undergoing thoracoscopic pulmonary wedge resection by harmonic scalpe, the operation time was 90.09±43.52 min, the blood loss was 21.32±12.75 ml, the number of lymph nodes resected was 5.12±4.26, duration of drainage was 3.15±1.16 d, volume of drainage was 535.00±291.69 ml, the length of postoperative hospital stay was 4.56±1.40 d, and no postoperative complication was observed. In the 80 patients receiving thoracoscopic pulmonary lobectomy by harmonic scalpel, operation time was 131.88±41.82 min, blood loss was 42.79±31.62 ml, the number of lymph nodes resected was 13.54±8.75, duration of thoracic drainage was 4.47±2.30 d, drainage volume was 872.09±585.24 ml, the length of postoperative hospital stay was 5.81±2.26 d, and 20 patients had postoperative complications. No complication occurred in the 8 patients without harmonic scalpel.
Conclusion
Harmonic scalpel showed satisfactory effectiveness and safety in lung cancer thoracoscopic surgery.
Objective To compare the disadvantages and advantages of open thyroid surgery when using the harmonic scalpel (HS) vs conventional hemostasis (CH). Methods One hundred and fifty-one patients and 70 patients underwent thyroid surgery with HS or CH respectively. The tumor diameter, incisional length, the total operative time, thyroidectomy time, intraoperative bleeding volume, postoperative drainage volume and surgical complications were compared. The incisional length and the surgical complications in and after learning curve with harmonic scalpel were compared. Results There was no significant difference between the HS and CH group at baseline. Incisional length, total operative time, thyroidectomy time, intraoperative bleeding volume and postoperative drainage volume in HS group were significantly lower than those of CH group (P＜0.001); the surgical complications showed no significant difference between the HS and CH group (Pgt;0.05); the incisional length after learning curve was shorter than that in learning curve in HS group (P＜0.05); the surgical complications after learning curve were significantly lower than that in learning curve in HS group (P＜0.001). Conclusion HS provides significant advantages over conventional hemostasis in open thyroid surgery. However, it can’t be used in a blindly exclusive way but be combined with conventional knot tying appropriately.
An intervention with clinical application must be effective and safe, therefore, when evaluating interventions, the benefit-harm ratio should be considered, and only those interventions with more benefits than harms have application value. To evaluate the benefits and harms of an intervention evidence of both benefits and harms should be reported in clinical trials. To promote better reporting of harms in randomized controlled trials, the CONSORT group had added an entry on harms in the 2001 version of the CONSORT statement, and then in 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated, the reporting of harms is still inadequate. The CONSORT group has updated《Better reporting of harms in randomized trial: an extension of the CCONSORT statement.》, published《CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials》. This article presents and explains the Harms 2022, with the aim of helping researchers better understand and use the statement, with a view to improving the reporting quality of harms in clinical trials.
ObjectiveTo investigate the cause and treatment for chyle fistula after neck radical dissection using harmonic scalpel. MethodsFrom January 2005 to April 2009, 105 patients with thyroid carcinoma underwent thyroidectomy by harmonic scalpel (harmonic scalpel group) and 110 patients with thyroid carcinoma by conventional procedures (conventional group). Postoperative chyle fistula in all the cases was studied retrospectively. ResultsThe incidence of chyle fistula was 5.71% (6 of 105 patients) in the harmonic scalpel group and 0.91% (1 of 110 patients) in the conventional group. The difference was significant between two groups (Plt;0.05). ConclusionsHarmonic scalpel increases the risk of chyle fistula in neck radical dissection. The conventional procedures with exposing and preserving or ligating the thoracic duct can reduce the risk significantly.
Objective
To assess the outcome of harmonic scalpel (HS) in esophageal cancer surgery and to provide evidence for the role of HS in the enhanced recovery after surgery (ERAS) and short-term prognosis after esophageal cancer surgery.
Methods
We collected the clinical data of 81 esophageal cancer patients receiving surgery by HS between January 1 and December 31, 2016 and successfully followed up in our department. There were 67 males and 14 females with an average age of 64.07±7.52 years. Sweet approach was adopted in 16 patients, Ivor-Lewis approach in 23 and McKeown approach in 40. Intrathoracic anastomosis was completed in 41 patients and cervical anastomosis in 40. The length of total hospital stay and postoperative hospital stay, operation time, intraoperative blood loss, duration and volume of thoracic drainage and perioperative complications were recorded and compared in patients with different surgical approaches and anastomosis sites.
Results
For these 81 patients, the operation time was 276.7±70.4 min, and the intraoperative blood loss was 115.9±69.7 ml. The postoperative duration of thoracic drainage, postoperative complication rate and the drainage volume were 12.3±5.3 d, 35.80% and 1 411.9±1 199.5 ml, respectively. During the follow-up, 15 patients died and the cumulative survival rate was 81.48%. There was no obvious HS-related complication. The operation time of Sweet approach was shorter than that of Ivor-Lewis or McKeown approach (P=0.012) and the dissected lymph nodes were less in Sweet approach (P=0.035). There was no significant difference in perioperative indexes and postoperative short-term prognosis between intrathoracic anastomosis and cervical anastomosis.
Conclusion
HS is widely used in the surgery for esophageal cancer with safety and effectiveness, which is worthy of clinical application.
