- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01583790
Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients
A Prospective Trial for Laparoscopic Adjustable Gastric Banding in Morbidly Obese Patients: Report on Weight Loss, Metabolic Changes and Quality of Life
연구 개요
상세 설명
In the period 2006-2012 the ICBS-Israeli Center for Bariatric Surgery in Assuta Hospital has performed about 1500 bariatric surgeries including Laparoscopic Adjustable Gastric Banding, Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux en Y Gastric Bypass, and Duodenal switch. In addition, Pose and BPD procedures were performed.The ICBS team is comprised of a team of expert senior professionals in the obesity field, made up of the best bariatric surgeons, an expert endocrinologist who specializes in obesity and diabetes, a team of senior nutritionists and a supportive psychology team. During that period patients data were collected as part of the medical practice in the Center and included BMI, co-morbidities, weight loss programs the patients were involved in, pervious bariatric surgery and quality of life. During the entire 6 years of follow up data were collected which included weight loss, resolution of co-morbidity, changes in quality of life etc combined with training for healthy lifestyle.
The purpose of this retrospective study is to evaluate the key factors for surgery success that includes over 50% of original weight loss, resolution of co-morbidities. Factors that could affect surgical outcome such as age, repeated surgery, early side effects such as bleeding, leakage, thrombosis and lung emboli were recorded as well as later side effects such as herniation of the surgical area, production of gallbladder stones, vitamine deficiency and requirement of a revision surgery.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Tel Aviv, 이스라엘
- 모병
- Assuta Medical Center
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연락하다:
- Asnat Raziel, MD
- 전화번호: 972-3-7645444
- 이메일: drraziel@zahav.net.il
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수석 연구원:
- Asnat Raziel, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patients meeting established criteria set by the National Institutes of Health (NIH) for candidacy for bariatric surgery
- patients having a body mass index (BMI) of 35 with co-morbid conditions or BMI larger or equal 40 with or without co-morbid conditions,
- patients having a comorbidity that should be improved by the surgery
- Patients that are able to comprehend the risks and benefits and the surgical procedure
- patients having no glandular etiology for their obesity
- patients that have attempted to lose weight by conventional means
- patients that are willing to be observed over a long period of time
Exclusion Criteria:
- patients that can not obey one of the inclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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no group
laparoscopic sleeve gastrectomy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Weightloss of patients
기간: At least one year
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At least one year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Improvement of co-morbidities after surgery
기간: At least one year
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Follow up visits were done at 1, 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery.
They included physical examinations, blood analysis and assessment of comorbidities in collaboration with attending family physician.
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At least one year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Asnat Raziel, MD, Medical Director, ICBS-Israeli Center for Bariatric Surgery
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .