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Clinical Trials/NCT03578211
NCT03578211
Completed
Not Applicable

Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital1 site in 1 country140 target enrollmentMay 1, 2018
ConditionsObesity, Morbid

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Morbid
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
140
Locations
1
Primary Endpoint
Decisional conflict
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
July 7, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Principal Investigator
Principal Investigator

SU YEN-HAO

Director of Metabolic and Weight Management Center

Taipei Medical University Shuang Ho Hospital

Eligibility Criteria

Inclusion Criteria

  • Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
  • Body mass index (BMI) ≧ 37 kg / m2

Exclusion Criteria

  • Endocrine system abnormalities in patients
  • Drug abuse or mental illness
  • Major organ dysfunction and can accept surgery
  • Patients cannot understand Chinese
  • Age less than 20 years old or more than 70 years old

Outcomes

Primary Outcomes

Decisional conflict

Time Frame: One week after intervention

Total scores of decisional conflict scale

Secondary Outcomes

  • Decision regret(3 month after bariatric surgery)

Study Sites (1)

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