Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study
연구 개요
상세 설명
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy.
The study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent.
The day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin).
The day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization.
At Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization.
At the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Clermont-Ferrand, 프랑스, 63003
- 모병
- CHU de Clermont-Ferrand
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and
- benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.
and
- affiliation to social security and
- informed consent
Exclusion Criteria:
- ASA III or IV patients,
- age> 80 years old,
- history of major abdominal surgery by laparotomy
- severe obesity (BMI> 35kg / m2)
- pathology of hemostasis and coagulation (liver disease, bleeding disorders)
- uterine volume estimated on preoperative ultrasonography > 300 g
- minor patients,
- adult lacking legal capacity
- patients suffering from mental illness incompatible with informed consent, refusal to participate.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: standard instrument
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
|
|
다른: less than 3 millimeter diameter's instruments
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
operative time
기간: at day 1 (at the end of the surgery)
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at day 1 (at the end of the surgery)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
quantity of intraoperative bleeding
기간: at day 1 (at the end of the intervention)
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at day 1 (at the end of the intervention)
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hemoglobin
기간: at day 1
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at day 1
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Pain Rating Scale (VAS)
기간: at day 1 (at 6 hours potoperative hours)
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at day 1 (at 6 hours potoperative hours)
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Pain Rating Scale (VAS)
기간: at day 1 (at 24 postoperative hours)
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at day 1 (at 24 postoperative hours)
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standard laparoscopy conversion rate
기간: at day 1
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at day 1
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postoperative complications
기간: at each additional hospitalisation
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postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
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at each additional hospitalisation
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Patient Scar Assessment Scale (PSAS)
기간: at 6 and 8 weeks after surgery.
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Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
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at 6 and 8 weeks after surgery.
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Surgen's ergonomics
기간: at the end of the surgery
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Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
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at the end of the surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Revaz BOTCHORISHVILI, CHU de Clermont-Ferrand
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHU-0223
- 2014-A01698-39 (기타 식별자: ANSM)
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