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1.
World J Gastroenterol ; 26(23): 3271-3282, 2020 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-32684741

RESUMO

BACKGROUND: During the perioperative period, the characteristic therapy of traditional Chinese medicine is effective in improving postoperative rehabilitation. In large-scale hospitals practicing traditional Chinese medicine, there is accumulating experience related to the promotion of fast recovery in the perioperative period. AIM: To evaluate the efficacy and safety of Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique. METHODS: This prospective, multicenter, randomized, controlled study included two groups: Treatment group and control group. The patients in the treatment group and control group received Yikou-Sizi powder hot compress on Shenque acupuncture point combined with rapid rehabilitation technique and routine treatment, respectively. Clinical observation regarding postoperative recovery of gastrointestinal function was performed, including the times to first passage of flatus, first defecation, and first normal bowel sounds. The comparison between groups was conducted through descriptive analysis, χ 2, t, F, and rank-sum tests. RESULTS: There was a statistically significant difference in the time to postoperative first defecation between the treatment and control group (87.16 ± 32.09 vs 109.79 ± 40.25 h, respectively; P < 0.05). Similarly, the time to initial recovery of bowel sounds in the treatment group was significantly shorter than that in the control group (61.17 ± 26.75 vs 79.19 ± 33.35 h, respectively; P < 0.05). However, there was no statistically significant difference in the time to initial exhaust between the treatment and control groups (51.54 ± 23.66 vs 62.24 ± 25.95 h, respectively; P > 0.05). The hospitalization expenses for the two groups of patients were 62283.45 ± 12413.90 and 62059.42 ± 11350.51 yuan, respectively. Although the cost of hospitalization was decreased in the control group, the difference was not statistically significant (P > 0.05). This clinical trial was safe without reports of any adverse reaction or event. CONCLUSION: The rapid rehabilitation technique with integrated traditional Chinese and Western medicine promotes the recovery of postoperative gastrointestinal function and is significantly better than standard approach for patients after colorectal surgery.


Assuntos
Medicina Tradicional Chinesa , China , Humanos , Período Pós-Operatório , Estudos Prospectivos , Recuperação de Função Fisiológica , Resultado do Tratamento
2.
Medicine (Baltimore) ; 97(38): e12438, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30235726

RESUMO

BACKGROUND: Postoperative gastrointestinal dysfunction (PGD) is a common complication of patients who have undergone surgery. The clinical manifestations cause great discomfort to postoperative patients and can severely affect postoperative recovery. However, although various pharmacologic agents have been explored for several years, success has been limited. Because some commonly used drugs have caused adverse reactions and because abdominal surgery patients generally cannot consume food or medication during the perioperative period, we were prompted to try an external Chinese medicine treatment method. Yikou-Sizi powder hot compress is an efficient therapy in our hospital, but there is a lack of rigorous studies to certify the safety and effectiveness of its external use to improve gastrointestinal motility. This study aimed to introduce the clinical trial design and test the ability of Yikou-Sizi powder hot compress treatment to accelerate gastrointestinal functional recovery after abdominal surgery. METHODS: This study is a randomized controlled clinical trial. The participants will undergo laparoscopic colorectal cancer surgery and laparoscopic total hysterectomy. The primary outcome measure will be the gastrointestinal functional evaluation index, including the time to first passage of flatus, first defecation, first normal bowel sounds, and first consumption of liquid/semigeneral diet foods. According to good clinical practice (GCP), we will evaluate the clinical efficacy and safety of Yikou-Sizi powder hot compress and objectively study the acting mechanism of ghrelin. This pilot trial will be a standard, scientific, and clinical study designed to evaluate the effect of Yikou-Sizi powder hot compress for the recovery of gastrointestinal function after surgery and determine its overall safety. DISCUSSION: This is the first study to describe the use of Yikou-Sizi powder hot compress to accelerate the recovery of gastrointestinal function after abdominal surgery. The study is designed as a randomized, controlled, clinical, large sample size and pilot trial. Evaluation will consist of combining the primary outcome measures with secondary outcome measures to ensure the objectivity and scientific validity of the study. Due to the observational design and the limited follow-up period, it is not possible to evaluate to what extent the connection between the observed improvement and the interventions represents a causal relationship. Efficient comparison between groups will be analyzed by chi-square test.


Assuntos
Neoplasias Colorretais/cirurgia , Gastroenteropatias/cirurgia , Motilidade Gastrointestinal/fisiologia , Laparoscopia/efeitos adversos , Medicina Tradicional Chinesa/métodos , Recuperação de Função Fisiológica/efeitos dos fármacos , Adulto , Idoso , Feminino , Humanos , Histerectomia/efeitos adversos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/terapia , Recuperação de Função Fisiológica/fisiologia
3.
Trials ; 19(1): 146, 2018 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-29486765

RESUMO

BACKGROUND: Most patients who undergo abdominal surgery recover bowel movements within a week; however, some suffer prolonged intestinal paralysis or postoperative ileus (POI) leading to complications, such as infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. Chinese medicine is effective for accelerating the recovery of gastrointestinal function after abdominal surgery. Xiangbin prescription (XBP) is the standard prescription for this purpose in our hospital; however, randomized controlled trials of it have not yet been conducted. METHODS/DESIGN: This double-blind, randomized controlled clinical trial aims to recruit patients who have undergone abdominal surgery and experienced postoperative dysmotility to evaluate the efficacy and safety of XBP for preventing POI and accelerating recovery. The research will tackle the common problem of slow recovery of gastrointestinal function after surgery. The participants will be patients who undergo laparoscopic radical resection of rectal carcinoma or laparoscopic panhysterectomy of a benign lesion. Primary outcome measures will be time to first flatus, defecation, normal bowel sounds, and liquid/semi-liquid/general diet. Good Clinical Practice (GCP) standards of efficacy and safety will also be evaluated, along with objective investigation of the mechanism of action of ghrelin. DISCUSSION: This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of XBP for the recovery of gastrointestinal function after surgery, and it will conform to international standards for clinical trials for the recognition of traditional Chinese medicine. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR-TRC-14004156 . Registered on 3 January 2014.


Assuntos
Abdome/cirurgia , Medicamentos de Ervas Chinesas/uso terapêutico , Histerectomia/efeitos adversos , Pseudo-Obstrução Intestinal/prevenção & controle , Laparoscopia/efeitos adversos , Neoplasias Retais/cirurgia , Adulto , Idoso , China , Defecação/efeitos dos fármacos , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/farmacologia , Feminino , Flatulência , Humanos , Pseudo-Obstrução Intestinal/diagnóstico , Pseudo-Obstrução Intestinal/fisiopatologia , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento
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