Impact of Decision Aids on Bariatric Surgery Choice

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578211
• Other study ID #: N201804032
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: July 7, 2020

Study information

• Verified date: May 2022
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 7, 2020
• Est. primary completion date: May 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Body mass index (BMI) ? 32 kg / m2 with obesity-related comorbidity

2. Body mass index (BMI) ? 37 kg / m2

Exclusion Criteria:

1. Endocrine system abnormalities in patients

2. Drug abuse or mental illness

3. Major organ dysfunction and can accept surgery

4. Patients cannot understand Chinese

5. Age less than 20 years old or more than 70 years old

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Behavioral:
• Shared decision making with decision aids
For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Shuang Ho Hospital	New Taipei City	Zhonghe District

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	Total scores of decisional conflict scale	One week after intervention
Secondary	Decision regret	Total scores of decision regret	3 month after bariatric surgery