Prophylactic Moxibustion in Preventing Postoperative Urinary Retention of Hemorrhoidectomy: A Study Protocol for a Randomized Controlled Trial

Abstract

BackgroundsPostoperative urinary retention (POUR) is one of the most common complications after hemorrhoidectomy. The best treatment for POUR is prevention and should be involved in the whole perioperative period. Moxibustion has been used to treat urinary retention for thousands of years, and clinical studies have also proved its effects. We try to carry out a randomized, controlled, prospective study to observe whether prophylactic moxibustion could effectively reduce the incidence of POUR of hemorrhoidectomy in 24 h.MethodsThis study is a single-center, evaluator-blinded, randomized, and controlled trial. Participants who meet the inclusion and exclusion criteria in this RCT will be randomly assigned to either the treatment group (moxibustion) or the control group (tamsulosin hydrochloride) in a 1:1 ratio according to a computer-generated randomization list. Both moxibustion and tamsulosin will be used 1, 10, and 24 h after operation, respectively. The outcomes of occurrence of POUR, time to first urination, catheterization rate, urinary tract infection, length of hospitalization, and adverse effects will be recorded.DiscussionThe findings of the study will help to explore the preventive efficacy of prophylactic moxibustion against POUR of hemorrhoidectomy in 24 h.Trial RegistrationCHiCTR, CHiCTR2000039350, registered 24 October, 2020, http://www.chictr.org.cn/showproj.aspx?proj = 63204.

General anesthesia with local infiltration reduces urine retention rate and prolongs analgesic effect than spinal anesthesia for hemorrhoidectomy

“…However, the side effects of non-steroidal anti-inflammatory drugs, including nephrotoxicity, gastric ulcer, nausea, vomiting, dizziness, and allergic reactions, limit their usage and effectiveness. Other atypical pain relief methods, such as botulinum toxin injection (2), moxibustion (25), and oral flavonoids (11), have been documented but are not as popular and effective. Although the oral antibiotic metronidazole can reduce pain (9,10), it has a risk of gastrointestinal side effects.…”

DataSheet1.PDF

“…At the end of the study, the investigator will submit the CRFs to the data management committee, and the investigators cannot modify the data. The data monitoring committee is independently chaired by the Statistics Teaching and Research Office of Changshu Hospital Affiliated to Nanjing University of Chinese Medicine and claims no conflict of interest [403]. ② The data monitoring committee is independently chaired by the Statistics Teaching and Research Office of Guangzhou University of Chinese Medicine and claims to have no conflict of interest.…”

“…① "Fully reported" was considered if there was information related to the name and number of acupoints/locations (if no official name). For the name, they could be standard nomenclature for acupoints, anatomical locations, "The pain site was selected for ① Points of Qihai (CV 6), Zhongji (CV 5), Guanyuan (CV 4), and bilateral Sanyinjiao (SP 6) will be selected for moxibustion [403]. ② The sites for thunder-fire moxibustion will be selected along the governor meridian in its spinal moxibustion treatment" reported in the article, or other expressions with similar meanings.…”

“…① "Fully reported" was considered if there was information related to the materials used for moxibustion, such as moxa floss (white, soft, cotton-like fibers prepared from moxa ① The moxa rolls for moxibustion are produced by Nanyang Chinese Medicine Airong Co. Ltd., in 18 × 200 mm [403]. leaves), moxa cone (cone-like shape made of moxa wool and commonly with three different sizes), moxa stick (strick wrapping moxa floss and some other herbs), indirect moxibustion materials (ginger, garlic, salt, monkshood cake, medicinal herbs and paper), special apparatuses (moxa burner), special form of moxibustion using herbs other than moxa (natural moxibustion-Tianjiu), etc.…”