NCT04554758

Brief Summary

Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

September 9, 2020

Last Update Submit

October 6, 2020

Conditions

Obesity, MorbidOvernutritionNutrition DisordersOverweight and ObesityBody Weight Changes

Keywords

primary bariatric surgerymorbid obesitysleeve gastrectomyRoux-en Y gastric bypassSouth Korea

Outcome Measures

Primary Outcomes (3)

  • Obesity Cure Success Rate

    Proportion of patients who reach BMI bellow 25

    Postoperative 1 year

  • Body weight change rate

    Decreased body weight proportion compare to preoperative body weight

    Postoperative 1 year

  • Waist circumference change rate

    Decreased waist circumference change proportion compare to preoperative waist circumference

    Postoperative 1 year

Secondary Outcomes (8)

  • Rate of morbid disease remission or partial remission

    Postoperative 1 year, 2 year

  • Postoperative complication rate and mortality rate

    Within postoperative 30 days

  • Micronutrient deficiency

    Postoperative 1 year, 2 year

  • Quality of life improvement rate and degree-1

    Postoperative 1 year, 2 year

  • Quality of life improvement rate and degree-2

    Postoperative 1 year, 2 year

  • +3 more secondary outcomes

Study Arms (2)

Sleeve gastrectomy

EXPERIMENTAL

200 obesity patients who undergo laparoscopic sleeve gastrectomy

Procedure: Sleeve gastrectomy

Roux-en-Y gastric bypass

EXPERIMENTAL

200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass

Procedure: Roux-en-Y gastric bypass

Interventions

Sleeve gastrectomyPROCEDURE

Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.

Sleeve gastrectomy
Roux-en-Y gastric bypassPROCEDURE

Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.

Roux-en-Y gastric bypass

Eligibility Criteria

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

You may qualify if:

  • obesity patients(BMI over 35)
  • morbid obesity patients(BMI over 30) with cardiovascular disease, hypertension, hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea
  • type 2 diabetes mellitus obesity patients(BMI over 27.5) who were treated medical therapy or HbA1C level over 7%

You may not qualify if:

  • Patients who underwent previously bariatric operation
  • Patients who were diagnosed malignant disease patients within 5 years
  • Patients who were involved with other clinical trial within 3 months
  • Patients who are risky to conduct general anesthesia for operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, South Korea

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidOvernutritionNutrition DisordersOverweightObesityBody Weight Changes

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Yoon Seok Heo, Professor

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

  • Do Joong Park, Professor

    Seoul National University Hospital

    STUDY DIRECTOR

  • Yong Suk Park, Professor

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

  • Seung Wan Ryu, Professor

    Keimyung University Hospital

    STUDY DIRECTOR

  • Moon Won Yoo, Professor

    Ulsan univertisy Seoul Asan Medical Center

    STUDY DIRECTOR

  • Han Hong Lee, Professor

    The Catholic University of Korea

    STUDY DIRECTOR

  • Ji Yeon Park, Professor

    Kyungpook National University Hospital

    STUDY DIRECTOR

  • Sang Hyun Kim, Professor

    Soonchunhyang University Hospital

    STUDY DIRECTOR

  • Jong Won Kim, Professor

    Chung-Ang University Hopspital

    STUDY DIRECTOR

  • Jong Han Kim, Professor

    Korea University Medical Center(Guro Hospital)

    STUDY DIRECTOR

  • In Seob Lee, Professor

    Ulsan univertisy Seoul Asan Medical Center

    STUDY DIRECTOR

  • In Gyu Kwon, Professor

    Yonsei University Medical Center(Gangnam Hospital)

    STUDY DIRECTOR

  • Tae Kyung Ha, Professor

    Hanyang University

    STUDY DIRECTOR

  • Sung Il Choi, Professor

    Kyung Hee University Hospital at Gangdong

    STUDY DIRECTOR

  • Kyung Won Seo, Professor

    Kosin University Gospel Hospital

    STUDY DIRECTOR

Central Study Contacts

Yoon Seok Heo, Professor

CONTACT

+82-32-890-3437gsheo@inha.ac.kr

Yun Suk Choi, Instructor

CONTACT

+82-32-890-3437yunsukki@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative double arm study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 18, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2023

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

KR(1)