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.
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.
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.
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.
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.
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 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.
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.
ObjectiveTo summarize the new ideas and new instruments in thyroid surgery. MethodsRelated literatures were reviewed and analyzed. ResultsTotal thyroidectomy had become the preferred option for differentiated thyroid cancer and multiple nodule goiter. The key change of surgery was from recurrent laryngeal nerve-protection to parathyroid-protection. Harmonic scalpel, bipolar coagulation forceps and Ligasure were used to thyroid surgery, which could shorten operation time and reduce operative bleeding. ConclusionThe ideas and techniques of thyroid surgery have changed, total thyroidectomy and parathyroid protection are being paid more and more attentions, and new instruments are used more extensively in thyroid surgery.
NNT defines the number of patients who need to be treated in order to achieve one additional favorable outcome, and NNH is defined as the number of patients who must be treated with a therapy in order to have one additional patient suffer an adverse effect compared with the control treatment. This is the most important thing that should beconsidered before administering a treatment. NNT can also be used to assess the relative benefit or harm in the comparison of intervention versus positive control. If the effect is smaller in the intervention group than that in the control group, NNT should be used; if the effect is bigger in the intervention group than that in the control group, NNH should be used. When comparison is made between an intervention versus placebo, NNT and NNH are absolute outcomes; when an intervention is compared to a positive control, NNT and NNH are relative outcomes. RR or OR or RD may help to judge which comparator has bigger or smaller effect, and whether NNT or NNH should be used.