NCT04318821

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 10, 2022

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

March 16, 2020

Last Update Submit

March 8, 2022

Conditions

Adhesive Small Bowel Obstruction

Keywords

Adhesive small bowel obstructionLaser acupunctureAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Success rate of conservative treatment

    Defined as no need for long term nasogastric tube decompression and operative intervention.

    2 week

Secondary Outcomes (8)

  • Time to oral intake

    2 weeks

  • Length of hospital stay

    Through study completion, an average of 1 year

  • Serum lipase

    Up to 2 weeks

  • Serum amylase

    Up to 2 weeks

  • Serum cortisol

    Up to 2 weeks

  • +3 more secondary outcomes

Study Arms (2)

LA group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

Laser acupuncturePROCEDURE

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

Control groupLA group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20 to 80 years
  • Clinical symptoms and signs of mechanical obstruction

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (1)

  • Shih CH, Hsieh TM, Wu BY, Liu CT. Effect of laser acupuncture on adhesive small bowel obstruction: A prospective double-blind randomized controlled trial. Medicine (Baltimore). 2021 Mar 5;100(9):e25035. doi: 10.1097/MD.0000000000025035.

    PMID: 33655978DERIVED

Study Officials

  • Chun-Ting Liu, MD

    Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Ting Liu, MD

CONTACT

+886-7-7317123juntin0214@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The participants in each group will receive real (with energy output) or sham (without energy output) laser acupuncture. The feelings of participants in each group are not different. The care provider and outcomes assessor don't involve the random allocation and don't know if participants receive real laser acupuncture.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 24, 2020

Study Start

March 1, 2020

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 10, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)