Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction

Not Applicable

• Conditions: Adhesive Small Bowel Obstruction
• Interventions: Procedure: Laser acupuncture

• Registration Number: NCT04318821
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-22
• Study First Posted: 2020-03-24
• Status Verified: 2021-07
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LA group	Laser acupuncture	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).
Control group	Laser acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Success rate of conservative treatment	2 week	Defined as no need for long term nasogastric tube decompression and operative intervention.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan