NOTES Transvaginal Cholecystectomy and Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES
研究概览
简要总结
Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma.
In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for group #1 Transvaginal cholecystectomy:
- •Females between the ages of 18 and 50
- •Diagnosis of gallstone disease which requires cholecystectomy
- •ASA class 1
排除标准
- •for group #1 Transvaginal cholecystectomy:
- •Pregnant women
- •Morbidly obese patients (BMI > 35)
- •Patients who are taking immunosuppressive medications and/or immunocompromised
- •Patients with severe medical comorbidities will be excluded.
- •Patients with a presumed gallbladder polyps, mass or tumor
- •Patients with a history of prior open abdominal or transvaginal surgery.
- •Patients with a prior history of peritoneal or vaginal trauma
- •Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
- •Patients with known common bile duct stones
- •Patients on blood thinners or aspirin or abnormal blood coagulation tests
- •Inclusion Criteria for group #2 Transvaginal appendectomy:
- •Clinical diagnosis of appendicitis
- •Emergency room evaluation within 36 hours of the onset of pain
- •ASA Classification
- •Exclusion Criteria for group #2 Transvaginal appendectomy:
- •pregnant women
- •Morbidly obese patients (BMI >35)
- •Patients who are taking immunosuppressive medications or are immunocompromised
- •Patients with evidence of an abdominal abscess or mass
- •Patients who present with a clinical diagnosis of sepsis or peritonitis
- •Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
- •Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
- •Patients with diffuse peritonitis on clinical exam
- •Previous trauma to the perineal area
- •Patients on blood thinners or aspirin or abnormal blood coagulation tests
研究组 & 干预措施
1
NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.
干预措施: NOTES Transvaginal Cholecystectomy (Procedure)
2
NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina.
干预措施: NOTES Transvaginal Appendectomy (Procedure)
结局指标
主要结局
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES
时间窗: continuous
次要结局
- TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH(continuous)