YKSZS for ERAS after gynecological laparoscopy

This is a dataset from a prospective, single-blind, randomized controlled clinical trial investigating the efficacy of YiKou SiZi San powder external application on gastrointestinal function recovery following gynecological laparoscopic surgery.Study Design and ObjectivesThis study aims to evaluate the promoting effect of the traditional Chinese medicine formula "YiKou SiZi San" external application on postoperative gastrointestinal function recovery in patients undergoing gynecological laparoscopic surgery. The study employs a randomized controlled design, allocating subjects into two groups based on randomization numbers: Group 1 (SiZi San group, experimental arm) receiving traditional Chinese medicine external application intervention, and Group 2 (sandbag group, control arm) receiving conventional sandbag compression treatment.Data Timeline and Sample SizeData collection spanned from August 2020 to January 2022, comprising clinical data from 73 enrolled subjects. All cases underwent gynecological laparoscopic surgery, with surgical types including hysterectomy, ovarian lesion resection, uterine fibroid removal, pelvic adhesiolysis, and various other procedures.Baseline Characteristics Dataset ContentThe first dataset records comprehensive demographic and clinical information of the subjects. This includes basic information such as name, age, and admission date; a dual diagnostic system encompassing traditional Chinese medicine diagnoses (such as Zheng Jia, Beng Lou, Shi Jia) and Western medicine diagnoses (such as uterine fibroids, benign ovarian tumors, endometriosis); detailed surgical information covering operation date, specific procedure type, anesthesia duration, operative time, intraoperative blood loss, and operation end time. Postoperative management includes records of abdominal drainage tube and urinary catheter placement status and duration.Primary Efficacy EndpointsThe core of this dataset consists of time-to-event endpoints for gastrointestinal function recovery, all precisely recorded in hours: time to full liquid diet, time to semi-liquid diet, time to normal diet, as well as the key efficacy indicators of time to first postoperative flatus and time to first postoperative defecation. Additional recovery process indicators include postoperative intravenous fluid therapy days and total length of hospital stay.Concomitant Medications and Safety MonitoringThe data meticulously records concomitant medication usage, including whether subjects used traditional Chinese medicine decoctions, heparin anticoagulation, pantoprazole for gastric protection, and other drugs, along with their indications and duration of use. Safety monitoring encompasses documentation of adverse reactions and adverse events, as well as annotations for study discontinuation. Some cases were discontinued due to deep vein thrombosis, voluntary withdrawal, or other reasons.Laboratory Testing Dataset ContentThe second dataset comprises laboratory examination data at three time points: preoperative baseline, postoperative day 1, and postoperative day 3. Testing items include complete blood count parameters (white blood cells, red blood cells, hemoglobin, platelets); urinalysis (urinary protein, urinary white blood cells, urinary red blood cells, ketones); liver function indicators (alanine aminotransferase); renal function indicators (urea, creatinine); electrolyte levels (potassium, sodium, chloride ions); and serum albumin. Preoperative examinations also include chest X-ray and electrocardiogram results, while postoperative monitoring excludes chest X-ray.Data CharacteristicsTime data are recorded in a special format of "month.day-hour", for example "8.6-8" indicates 8:00 AM on August 6th. Some missing values exist in the data, annotated as "not recorded". Certain cases were excluded or voluntarily withdrew during the study, with specific dates annotated for each. Of particular note, subjects in both groups used traditional Chinese medicine decoctions, anticoagulant medications, or gastric protective drugs; these concomitant medications may have potential impacts on gastrointestinal function recovery outcomes and should be considered during data analysis.Research ValueThis dataset provides original clinical evidence for evaluating the application value of external traditional Chinese medicine therapy in enhanced recovery after surgery (ERAS) during the perioperative period. It is particularly suitable for statistical analyses including survival analysis, between-group comparisons, and safety assessments.