Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intensity of pain in motion
研究概览
简要总结
Laparoscopic surgery has become the golden standard for the removal of the gallbladder. Recently, developments have been made so that operations can be performed through a natural orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation using 2-3mm instruments in female patients. It also examines the benefits and disadvantages related to postoperative pain, cosmetic aspects, and potential physiological alterations to the transvaginal approach that affect sexual intercourse.
详细描述
The amount of trauma inflicted, especially in abdominal operations, depends largely on target organ access. Great efforts have been made to minimize access trauma. The further development of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal technique. The aim of this randomized study is to compare these two techniques in female patients that are in need of an elective cholecystectomy. The patients will be randomized on a 1:1 ratio into two treatment groups. In the needlescopic group the investigators will use two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In the transvaginal/transumbilical group the investigators will perform the Zornig technique using a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault. The primary endpoint of this trial is to measure the intensity of pain in motion measured from the day of the operation until postoperative day 2. Four different measurements of pain will be used. Furthermore the investigators examine perioperative complications as security parameters. The trial is supported in part by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gender: Female
- •Minimum Age: 18 Years
- •Maximum Age: 80 Years
- •indication for elective cholecystectomy on account of symptomatic cholecystolithiasis
- •age >=18 years and <=80 years
- •legal competence
排除标准
- •Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithiasis, pancreatitis, etc.)
- •liver cirrhosis (Child Pugh A, B, C)
- •severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA)
- •intact hymen
- •acute vaginal infection
- •lacking visibility of the uterine orifice
- •endometriosis
- •malignoma
- •obesity with a Body Mass Index (BMI) > 40 kg/m2
- •chronic abuse of analgesics or alcohol
- •neuromuscular disease that could interfere treatment or measures of pain
- •history of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria)
- •gravidity or breastfeeding
- •allergy against analgesics
- •patients who are dependent on or employed by the trial sponsor or physicians
- •institutionalisation for legal reasons
- •participation in other clinical studies that could interfere with the present trial
- •no written informed consent signed
结局指标
主要结局
Intensity of pain in motion
时间窗: at postoperative day 2
Pain Scores on the Visual Analog Scale (0-10)
次要结局
- Cumulative use of analgesics(10 days after the surgery)
- Return to everyday, work related and free time activities(3 months after operation)
- Duration of the operation(at the operation day)
- Cosmetic aspects and overall satisfaction with the results of the surgery(6 months after operation)
- Intraoperative complications(evaluated at the operation day)
- Surgical handling for the first and second surgeon(evaluated at the operation day)
- Intensity of pain in motion(at postoperative day 10)
- Quality of life(on postoperative day 10)
- Morphological consequences of transvaginal access(at the day before the operation, and again 10 to 14 days and 6 months after their surgery)
- Postoperative restrictions of sexual function(3 months after surgery)
- Conversionrate(at the operation day)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(at 6 month)
研究者
Dirk R. Bulian
Principal Investigator
University of Witten/Herdecke