In medical research, pilot and feasibility studies are conducted to reduce the uncertainty of future main trial and enhance its overall quality and probability of successful completion. The objective of a pilot and feasibility study is to answer whether the main trial can be performed, should be performed, and if so, how. Due to the tremendous resources, time, and funding required for a phase Ⅲ clinical trial, conducting a pilot and feasibility study is generally a pivotal step. While pilot and feasibility studies are gaining increasing attention in clinical research, efforts are largely required to promote the dissemination in China. Therefore, in this article, we briefly introduce the concepts of a pilot and feasibility study, its importance to the main trial, and current practice. Examples are also provided to help illustrate the introduction.
ObjectiveTo understand the economic burden of disinfection supply to medical institutions in Yibin City, and explore the feasibility of establishing a regional centralized management model of disinfection supply center in Yibin City.MethodsFrom April to May 2018, 263 medical institutions in the eight counties and two districts of Yibin City were investigated by means of mobile phone application-designed questionnaire, to obtain the information of cost accounting and economic burden of disinfection supply.ResultsThere were 263 medical institutions involved in the survey, in which 61 (23.19%) had set up the central sterile supply department (CSSD), including 43 public hospitals and 18 private hospitals; 202 medical institutions were without CSSD, which were mainly secondary hospitals [195 (74.14%), including 120 public hospitals and 75 private hospitals]. The higher the hospital level was, the larger the average area of the CSSD was; the difference was statistically significant (χ2=40.009, P<0.001). The higher the hospital level was, the more full-time personnel were employed, and the difference was statistically significant (χ2=31.862, P<0.001), and the care staff were the majority (66.23%). The cost burden of CSSD was more than 1 million yuan in the tertiary hospitals, which was 100 000 yuan or above in 61.90% of the secondary hospitals, and was below 100 000 yuan in hospitals below secondary level. The higher the hospital level was, the higher the total cost burden became; the difference was statistically significant (χ2=37.995, P<0.001). ConclusionIn view of the heavy economic burden of CSSD in medical institutions and the unbalanced setting up of medical institutions below secondary level, the establishment of a regional CSSD centralized management model is a new direction, new trend, and new model for future development, which is conducive to improving the quality of disinfection and sterilization, reducing medical care costs, making rational use of health resources, effectively preventing hospital infections, and ensuring the medical safety.
Objective To investigate the efficacy on clinical condition assessment and the safety of ultrasound-guided osteofascial chamber puncture manometry in evaluating the pressure of the osteofascial chamber in patients with venomous snake bites. Methods Patients with venomous snake bites admitted to the Department of Emergency Medicine of West China Hospital of Sichuan University between April 2021 and January 2023 were prospectively included, and their basic information, physiological indicators (heart rate, blood pressure), laboratory examination indicators, physical signs, treatment methods and prognosis were collected. The patients whose extremal pressure was measured by osteofascial chamber puncture under ultrasound guidance were selected as the manometry group. Patients who were bitten by venomous snakes at the same time without puncture pressure measurement were randomly selected as the control group at a ratio of 1∶1. The bleeding, infection, nerve injury, length of hospital stay and long-term prognosis of the two groups were compared to explore the safety of ultrasound-guided osteofascial chamber puncture manometry. The correlation between the pressure measured in the manometry group and creatine kinase (a representative index of acute poisoning severity score) was analyzed to explore the efficacy of ultrasound-guided osteofascial chamber puncture manometry in evaluating the disease. Results There was no significant difference between the manometry group and the control group in new or aggravated infection, bleeding, nerve injury (such as numbness and anesthesia), hospital treatment time, final detumescence time of the affected limb, or final adverse prognosis (P>0.05). There was a positive correlation between the measured pressure and creatine kinase (rs=0.286, P=0.002). Conclusions The higher pressure measured by ultrasound-guided osteofascial chamber puncture manometry is, the more serious the poisoning condition may be. In addition, ultrasound-guided osteofascial chamber puncture manometry does not prolong the hospital time of patients or the final swelling reduction time of the affected limb, and does not increase the incidence of bleeding, infection, nerve damage or eventual adverse prognosis events. It has clinical practicability and feasibility.
ObjectiveTo investigate the safety and feasibility of early mobilization in critically ill patients with femoral catheters, and to provide reference for guiding clinical rehabilitation training. MethodsThe literature on the safety and feasibility of early mobilization in critically ill patients with femoral catheters included in PubMed, EMbase, OVID, Springer-link, Wiley Online Library, and Web of Science up to June 2021 was searched, and relevant data were extracted for analysis. ResultsSeventy-two papers were initially screened, and 12 papers that met the criteria were finally included, covering 1 056 patients, and 489 patients had femoral catheters. Patients underwent 6 495 sessions of physical therapy, and a total of 62 patients had adverse events, including 14 (2.86%, 14/489) patients with catheter-related adverse events. ConclusionAlthough early mobilization in critically ill patients with femoral catheters may lead to adverse catheter-related events, the incidence is low. Therefore, the associated risks and benefits should be weighed in clinical practice, and femoral catheter is not recommended as a contraindication for early mobilization in critically ill patients.
目的 探討二級醫院神經內外科整合的可行性及優越性，觀察組織化醫療模式的臨床效果。 方法 將神經內、外科整合為一個一級臨床科室——腦系科，建立完善的多學科一體化治療的組織化醫療網絡體系。入選重型顱腦外傷和腦出血患者共289例，其中2004年8月-2008年12月在腦系科住院的重型顱腦外傷、腦出血患者共147例接受組織化醫療模式治療，作為治療組；2001年1月-2004年8月分散在我院內科、外科住院的重型顱腦外傷、腦出血患者共142例接受傳統常規治療，作為對照組。比較觀察兩組患者的治療效果。 結果 治療組神經功能缺損評分、日常生活活動能力評分和GCS分別為7.47±5.24、59.74±15.56和13.72±1.06；對照組分別為16.18±9.89、34.00±10.54和10.84±1.58。兩組比較，差異有統計學意義(Plt;0.05)。治療組與對照組比較，臨床治愈率提高55.64%，平均住院日縮短10.34 d，病死率降低21.26%，并發癥降低20.15%，致殘率降低20.24%。 結論 采用組織化醫療模式能明顯改善患者預后，縮短住院時間，提高患者的生活質量，是適合我國基層醫院神經內、外科危急重癥的治療模式，具有其可行性及優越性。
ObjectiveTo summarize the key technical points, applicability, feasibility, and safety of laparoscopic spleen-preserving distal pancreatectomy (LSPDP).MethodA retrospective analysis was performed for the clinical data of 22 patients who were admitted to the Affiliated Hospital of North Sichuan Medical College from September 2016 to November 2019, all patients planned to receive LSPDP.ResultsTwenty of the 22 patients successfully completed LSPDP, and 2 patients converted to laparotomy. One patient was transferred to laparotomy to suture the damaged splenic artery. The spleen was observed to have no ischemia and the spleen preservation operation was continued. One patient was converted to laparotomy due to the difficulty of dissecting the tail of the pancreas which caused by severe abdominal adhesion. The operation time of LSPDP patients was (191±86) minutes (170–480 min), intraoperative blood loss was (365±50) mL (200–1 000 mL), and postoperative hospital stay was (9.9±2.6) days (7–16 d). Six patients of pancreatic fistula occurred after operation, including 3 cases of biochemical fistula, which were cured and discharged after symptomatic treatment, 3 cases of grade B pancreatic fistula, who all improved after anti-inflammatory, acid suppression, enzyme suppression, and double catheter drainage. Twenty patients were interviewed after the operation, and the follow-up time was 3–24 months (median of 15 months). During the follow-up period, no patient had recurrence or metastasis.ConclusionsUnder the conditions of strict screening of suitable cases, adequate preoperative imaging evaluation, intraoperative fine manipulation, and the application of appropriate operating instruments and cutting closure devices, LSPDP is safe and feasible to treat benign tumors of the pancreatic body and tail and some borderline tumors. During the operation, attention should be paid to the reasonable treatment and protection of splenic arteries and veins.
Objective To explore the feasibility and safety of Frey operation under laparoscopy in the treatment of chronic pancreatitis. Methods The clinical data of chronic pancreatitis patients who underwent laparoscopic Frey procedure in Division of Pancreatic Surgery, Department of General Surgery, West China Hospital, Sichuan University from 2021-2023 were retrospectively analyzed. Results Eleven patients with chronic pancreatitis complicated with pancreatic duct stones were included in the study, 7 of whom had a history of diabetes and (or ) impaired glucose tolerance, suggesting that pancreatic endocrine function was impaired. The median diameter of the main pancreatic duct measured by imaging method was 8 mm (4–20mm). The median operative time was 188 min (120–368 minutes), and the total intraoperative bleeding volume was 50 mL (20–100 mL). Postoperative pancreatic fistula did not occur, one case of postoperative abdominal fluid accumulation and hypoproteinemia improved after symptomatic supportive treatment such as anti infection, acid and enzyme inhibition, and nutritional rehydration. Postoperative bleeding occurred in 3 cases, including 1 case of intestinal anastomotic bleeding, which was sutured again under emergency laparoscopic intestinal anastomosis to stop bleeding. The other two cases improved after conservative management such as blood transfusion, plasma, vitamin K, acid inhibition, enzyme inhibition and hemostatic drugs. The median postoperative hospitalization time was 7 days (4–18 days), and no patient mortality happened within 90 days after surgery. Conclusion Laparoscopic Frey operation is feasible and a relatively safe and effective method for the treatment of chronic pancreatitis.
Objective To explore the feasibility and the security of one-day stay ward in stripping surgery of saphenous vein varicosity. Methods Two hundred and eighty two patients treated in our hospital in 2011 were enrolled in this study， according to the operation mode， these patients were divided into 2 groups， ninety patients in one-day stay ward group and one hundred and ninety two patients in in-patient group. Their clinical features and medical operation indexs（included preoperative waiting time， duration of hospital stay， and medical cost）were retrospectively analyzed. Results There was no statistical differences on clinical features between the two groups. But compared with in-patient group， the preoperative waiting time， duration of hospital stay， and medical cost were shorter or lower in one-day stay ward group （P＜0.05）. Conclusions The one-day stay ward operation mode can decrease preoperative waiting time， duration of hospital stay and medical cost significantly， and it also can ensure the safety of clinical treatment. So it’s worthy in the clinical promotion.