Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction

Study Overview
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Brief Summary
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Adhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of admission after intra-abdominal surgery. To date, the ideal management of ASBO remains controversial. The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy in patients with ASBO.

Official Title
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Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction: a Prospective Double-blind Randomized Controlled Trial

Conditions
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Adhesive Small Bowel Obstruction

Intervention / Treatment
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* Procedure: Laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20 to 80 years Clinical symptoms and signs of mechanical obstruction Exclusion Criteria: Clear non-adhesive etiology of small bowel obstruction (e.g. tumor, hernia) Emergency surgical intervention before being admitted to the hospital Pregnancy Local skin infection on the acupoints, and limb amputees.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LA group<br>The subjects in the experimental group will receive 0.375 J of energy at each of the following acupoints: LI4 (Hegu, B3), PC6 (Neiguan, B3), ST25 (Tianshu, B3), ST36 (Zusanli, B2), CV4 (Guanyuan), CV12 (Zhongwan, B3). | Procedure: Laser acupuncture<br>* Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.<br>|
| Sham Comparator: Control group<br>The subjects in the control group will receive sham LA treatment, without any laser output (no stimulation) at the same acupoints used in experimental group. | Procedure: Laser acupuncture<br>* Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of conservative treatment | Defined as no need for long term nasogastric tube decompression and operative intervention. | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to oral intake | Defined as participants can try intake due to symptoms improved including nausea, vomiting, distension and pain. | 2 weeks | 
| Length of hospital stay | Date from admission to discharge | Through study completion, an average of 1 year | 
| Serum lipase | Serum lipase | Up to 2 weeks | 
| Serum amylase | Serum amylase | Up to 2 weeks | 
| Serum cortisol | Serum cortisol | Up to 2 weeks | 
| Serum motilin | Serum motilin | Up to 2 weeks | 
| Serum ghrelin | Serum ghrelin | Up to 2 weeks | 
| Serum intestinal fatty acid binding protein (I-FABP) | Serum intestinal fatty acid binding protein (I-FABP) | Up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesive small bowel obstruction, Laser acupuncture, Acupuncture