Chun-Han Shih1, Ting-Min Hsieh2, Bei-Yu Wu1,3, Chun-Ting Liu1,3. 1. Department of Chinese Medicine, Kaohsiung. 2. Department of Surgery, Division of Trauma, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine. 3. Graduate Institute of Integrated Medicine, College of Chinese Medicine, Research Center for Chinese Medicine & Acupuncture, China Medical University, Taichung, Taiwan.
Abstract
BACKGROUND: Adhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of re-admission after intra-abdominal surgery. The initial management of patients with ASBO is nonoperative treatment such as nil per os and decompression using a nasogastric tube. However, the ideal management of ASBO remains controversial. METHODS: This study will be a prospective, single-center, double-blind randomized controlled trial. Ninety two participants diagnosed with ASBO will be randomly assigned to either the verum or the sham laser acupuncture (SLA) group in a 1:1 ratio. All participants will undergo laser acupuncture (LA) or SLA once a day on 6 acupoints (LI4, PC6, ST25, ST36, CV4 and CV12) for 6 consecutive days after enrollment. The primary outcome measure will be the success rate of conservative treatment for ASBO. Secondary outcomes will be time to oral intake and length of hospital stay. The serum levels of lipase, amylase, cortisol, motilin, ghrelin, and intestinal fatty acid binding protein (I-FABP) will also be measured before intervention, on day 4, and on the day of discharge, respectively. Data will be analyzed by Chi-Squared test or t test between 2 groups. OBJECTIVES: The aim of this protocol is to investigate the clinical efficacy of LA on ASBO. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04318821. Registered on 24 March 2020.
BACKGROUND: Adhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of re-admission after intra-abdominal surgery. The initial management of patients with ASBO is nonoperative treatment such as nil per os and decompression using a nasogastric tube. However, the ideal management of ASBO remains controversial. METHODS: This study will be a prospective, single-center, double-blind randomized controlled trial. Ninety two participants diagnosed with ASBO will be randomly assigned to either the verum or the sham laser acupuncture (SLA) group in a 1:1 ratio. All participants will undergo laser acupuncture (LA) or SLA once a day on 6 acupoints (LI4, PC6, ST25, ST36, CV4 and CV12) for 6 consecutive days after enrollment. The primary outcome measure will be the success rate of conservative treatment for ASBO. Secondary outcomes will be time to oral intake and length of hospital stay. The serum levels of lipase, amylase, cortisol, motilin, ghrelin, and intestinal fatty acid binding protein (I-FABP) will also be measured before intervention, on day 4, and on the day of discharge, respectively. Data will be analyzed by Chi-Squared test or t test between 2 groups. OBJECTIVES: The aim of this protocol is to investigate the clinical efficacy of LA on ASBO. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04318821. Registered on 24 March 2020.
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