Effect of Laser Acupuncture on Adhesive Small Bowel Obstruction

Adhesive Small Bowel Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04318821
• Other study ID #: CMRPG8K0571
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2021
• Source: Chang Gung Memorial Hospital
• Contact: Chun-Ting Liu, MD
• Phone: +886-7-7317123
• Email: juntin0214[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Small Bowel Obstruction
• Intestinal Obstruction

Intervention

Procedure:
• Laser acupuncture
Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of conservative treatment	Defined as no need for long term nasogastric tube decompression and operative intervention.	2 week
Secondary	Time to oral intake	Defined as participants can try intake due to symptoms improved including nausea, vomiting, distension and pain.	2 weeks
Secondary	Length of hospital stay	Date from admission to discharge	Through study completion, an average of 1 year
Secondary	Serum lipase	Serum lipase	Up to 2 weeks
Secondary	Serum amylase	Serum amylase	Up to 2 weeks
Secondary	Serum cortisol	Serum cortisol	Up to 2 weeks
Secondary	Serum motilin	Serum motilin	Up to 2 weeks
Secondary	Serum ghrelin	Serum ghrelin	Up to 2 weeks
Secondary	Serum intestinal fatty acid binding protein (I-FABP)	Serum intestinal fatty acid binding protein (I-FABP)	Up to 2 weeks