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.
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.
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.
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.
ObjectiveTo explore the feasibility and safety of clinical application of bipolar coagulation forceps in open thyroid operations and summarize the operation skill. MethodsThe clinical data of 347 cases performed thyroid operations with bipolar coagulation forceps and Harmonic scalpel respectively from October 2010 to October 2014 in our hospital were analyzed retrospectively. ResultsNo statistical differences was found on the operative time, intraoperative bleeding, postoperative drainage, and postoperative hospitalization of the two groups (P > 0.05). The complications of transient palsy of recurrent laryngeal nerve and transient functional insufficiency of parathyroid were more in Harmonic scalpel group than in bipolar coagulation forceps group with statistical difference (P < 0.05). But there was no difference of the complications of airway obstruction, permanent injuries of recurrent laryngeal nerve, parathyroid and superior laryngeal nerve in the two groups (P > 0.05). ConclusionsThyroid operations with bipolar coagulation forceps are safe and feasible. Coagulation tightly along the thyroid capsule followed by incision with explicit subtle dissection is the key point of the decrease of complications.
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.
Objective To compare the advantages and disadvantages of using the harmonic scalpel and bipolar coagulation forceps versus harmonic scalpel and conventional clamp-and-tie technique in open thyroid surgery.Methods One hundred patients indicated for thyroid surgery were randomly divided into two groups：the bipolar coagulation forceps group underwent surgery with harmonic scalpel and bipolar coagulation forceps，and the conventional clamp-and-tie group with harmonic scalpel and conventional clamp-and-tie technique，respectively.All operations were performed by the same group of doctors.The total operation time，intraoperative bleeding，mass diameter，postoperative drainage，and surgical complications （postoperative bleeding， postoperative recurrent laryngeal nerve paralysis，seroma，and permanent postoperative hypoparathyroidism） were compared.Results There were 48 valid cases in the bipolar coagulation forceps group， and 49 cases in the conventional clamp-and-tie group. There were no significant differences between two groups patients of age，gender，disease composition，and mass diameter（P＞0.05）.With the same operative approach， the total operation time，intraoperative bleeding，and the incidence of transient postoperative hypoparathyroidism in the bipolar coagulation forceps group were significantly lower than those in the conventional clamp-and-tie group （P＜0.001）.The postoperative drainage in the bipolar coagulation forceps group was more than that in the conventional clamp-and-tie group （P＜0.05）.There was no single case of postoperative bleeding，postoperative recurrent laryngeal nerve paralysis，seroma，and permanent postoperative hypoparathyroidism in both groups.Conclusions The combination of harmonic scapel with bipolar coagulation forceps provides significant advantages over the combination of harmonic scapel with conventional clamp-and-tie technique in open thyroid surgery.
ObjectiveTo evaluate the feasibility of clipless laparoscopic cholecystectomy (LC) to patients with calculous cholecystitis in acute inflammation stage. Methods The clinical data of 169 patients with calculous cholecystitis in acute inflammation stage who underwent clipless LC from December 2008 to July 2010 were analyzed. ResultsAll patients were successfully operated by LC except one case who suffered from gallbladder perforation and a conversion to open surgery was performed. The operation time ranged from 25-70 min (mean 38 min). The blood loss ranged from 10-200 ml (mean 22 ml). Peritoneal drainage was done in 38 patients, and the drainage time ranged from 1-6 d (mean 1.8 d). The time to out-of-bed activity was at 2 h after operation and the hospitalization time was 3-7 d (mean 3.5 d). There was no complication such as bile duct injury, hemorrhage, billiary leakage, and intra-abdominal infection. ConclusionWith improvement of operator’s experiences and skills, the clipless LC becomes feasible and safe for patients with calculous cholecystitis in acute inflammation stage.
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.
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.