ABSTRACT
BACKGROUND: Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using TEAS in elderly patients subjected to gastrointestinal surgery, and comparing dual-acupoint and single-acupoint stimulation. METHODS/DESIGN: A multicenter, randomized, controlled, three-arm design, large-scale trial is currently undergoing in four hospitals in China. Three hundred and forty-five participants are randomly assigned to three groups in a 1:1:1 ratio, receiving dual-acupoint TEAS, single-acupoint TEAS, and no stimulation, respectively. The primary outcome is incidence of pulmonary complications at 30 days after surgery. The secondary outcomes include the incidence of pulmonary complications at 3 days after surgery; the all-cause mortality within 30 days and 1 year after surgery; admission to the intensive care unit (ICU) and length of ICU stay within 30 days after surgery; the length of postoperative hospital stay; and medical costs during hospitalization after surgery. DISCUSSION: The result of this trial (which will be available in September 2019) will confirm whether TEAS before and during anesthesia could alleviate the postoperative pulmonary complications after gastrointestinal surgery in elderly patients, and whether dual-acupoint stimulation is more effective than single-acupoint stimulation. TRIALS REGISTRATIONS: ClinicalTrials.gov, ID: NCT03230045 . Registered on 10 July 2017.
Subject(s)
Acupuncture Points , Digestive System Surgical Procedures , Electroacupuncture/methods , Gastrointestinal Tract/surgery , Respiratory Tract Diseases/prevention & control , Age Factors , Aged , China , Digestive System Surgical Procedures/adverse effects , Digestive System Surgical Procedures/economics , Digestive System Surgical Procedures/mortality , Electroacupuncture/adverse effects , Electroacupuncture/economics , Electroacupuncture/mortality , Female , Health Care Costs , Humans , Intensive Care Units , Length of Stay , Male , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Respiratory Tract Diseases/economics , Respiratory Tract Diseases/etiology , Respiratory Tract Diseases/mortality , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
In order to decrease the incidence of flap necrosis after reconstructive surgeries, new approaches are required. In the present study, a model of venous congested flaps in rats was established to test the heat shock protein (HSP) 90α, 'F-5', protein as an intervention therapy to alleviate ischemia-reperfusion injury. A recombinant plasmid pET15b-F-5 carrying the HSP90α gene was constructed and the induced protein was purified from bacterial cell cultures. The rats in the study were divided into three different intervention groups: group A rats were treated with normal saline prior to flap establishment, group B rats were treated with HSP90α, 'F-5', protein prior to flap establishment, and group C rats were treated with the same 'F-5' protein after the surgical procedure. Additionally, the reperfusion time-points, ischemia for 6 or 8 h (5 rats each), were established in each group. After set periods of time, the flaps were observed for skin appearance, blood flow, survival rate and histological changes including neovascularization and re-epithelialization. The results showed that the flaps in the rats pre-treated with 'F-5' protein performed better than the flaps of rats in the other two groups: the blood flow was higher, flap survival rate was increased, inflammatory cell infiltration was decreased and angiogenesis increased, and new skin structure was better completed by the end of the experiment. The parameters examind were improved for all the groups when the ischemia time was 6 h instead of 8 h. In conclusion, HSP90α intervention prior to flap establishment was shown to be beneficial in the model of ischemia-reperfusion injury in venous-congested flaps.
