- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00710502
Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial
Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic cholecystectomy was introduced in the early 1990s and has become the standard surgical approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed as an outpatient basis and is related to a very low complication rate. Laparoscopic cholecystectomy requires the use of multiple trocar incisions.
Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure currently being studied around the world. The idea of NOTES was developed several years ago in response to the concepts that patients would
- realize the benefits of less invasive surgery by reducing the recovery time,
- experience less physical discomfort associated with traditional procedures
- have virtually no visible scarring following this type of surgery.
All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold tremendous potential, there are many issues that need to be addressed before this technique is introduced into clinical care.
The purpose of this study is to determine the safety, feasibility and short-term clinical outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).
Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with symptomatic cholelithiasis.
Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.
Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal NOTES cholecystectomy to Laparoscopic cholecystectomy.
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Durango, 멕시코, 34000
- Universidad Juarez del Estado de Durango, Mexico
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult (> 18 years old) female patients residents of Durango Mexico.
- Patients who undergo elective surgery.
- Patients with ultrasound documented symptomatic cholelithiasis, gallbladder polyps of biliary dyskinesia.
- Patients capable of giving written informed consent for the study.
Exclusion Criteria:
- Patients who have contraindications prohibiting general anesthesia.
- Pregnancy.
- Previous abdominal or gynecological procedures.
- Uncontrollable medical or psychiatric conditions
- Elderly > 65 y/o.
- Body Mass Index > 35 mg/kg2.
- Complicated or acute cholecystitis.
- Elevation of liver function tests.
- Acute abdomen.
- Intra-abdominal abscess.
- Coagulopathy.
- Imperforated hymen.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
Transvaginal NOTES Cholecystectomy (Phase 1)
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Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
다른 이름들:
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활성 비교기: 2
Laparoscopic Cholecystectomy (Phase 2)
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Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
다른 이름들:
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실험적: 3
Transvaginal NOTES cholecystectomy (Phase 2)
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Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Homero Rivas, MD, Hospital de la Paz
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
Transvaginal NOTES cholecystectomy에 대한 임상 시험
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