Effects of Jianpi Lishi Jiedu Granules on Colorectal Adenoma Patients after Endoscopic Treatment: Study Protocol for a Randomized Controlled Trial

Abstract BackgroundColorectal adenomas (CRAs) are precancerous lesions of the large intestine presenting as colorectal polyps. At present, the conventional treatment methods for CRA mainly include high-frequency electrocoagulation and electroexcision, biopsy forceps polypectomy, cauterization by laser and microwave and other endoscopic interventions. The principal advantages conferred by these treatment strategies include less trauma, quick postoperative recovery, and simplicity to perform. However, the higher recurrence rates and insignificant improvement of postoperative symptoms associated with endoscopic surgery are considerable drawbacks to this approach. Besides, there is currently no effective pharmacotherapy to prevent the recurrence of CRA. Jianpi Lishi Jiedu (JLJ) Granules are a form of Traditional Chinese medicine (TCM) used to manage postoperative patients with CRA, which has shown a certain degree of efficacy in clinical practice. However, its effectiveness and safety profile have not been convincingly evaluated. The purpose of this study is to evaluate the clinical efficacy and safety profile of JLJ Granules in the management of postoperative patients with CRA, and to observe the recurrence rate of adenoma in these patients. MethodsA randomized, double-blind, and placebo-controlled clinical trial is performed in this study. A total of 80 postoperative patients with CRA will be randomly classified into the Jianpi Lishi Jiedu Granules group or the placebo control group. Patients in both groups shall receive 3 months of intervention, after which a safety evaluation will be performed for all of the patients. All of the patients must receive medical follow-up and evaluation of outcome indicators, including cardinal TCM symptom scores, minor TCM symptom scores, Bristol Stool Scale, efficacy of TCM symptoms, and reexamination of colonoscopy, on month 3, 6 and 12 to calculate the recurrence rate of adenomas. DiscussionIn this study, the efficacy and safety of JLJ Granules in terms of improving the clinical symptoms of postoperative patients with CRA, and its impact on the recurrence of adenomas will be evaluated. Trial registration: Trial registration Chinese Clinical Trial Registry ChiCTR 2100044297. Registered on March 16, 2021