The Effect of Transvaginal vs. Conventional Laparoscopic Cholecystectomy on the Postoperative Course
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Cumulated postoperative pain with visual analogue scale (VAS)
研究概览
简要总结
Uncomplicated laparoscopic cholecystectomy will in most patients result in moderate to severe pain until the first postoperative day. This will subside during the second and third postoperative day [1]. A feeling of low general well-being will also be present until the first postoperative day and subside during the next couple of days [2].
To achieve faster recovery after laparoscopic interventions it has been shown that a reduction in the size of laparoscopic ports and thereby incisions can reduce postoperative pain [3,4].
A new minimal invasive surgical technique is based on the principle of completely eliminating the use of ports through the abdominal wall. This new technique is called Natural Orifice Transluminal Endoscopic Surgery (NOTES) and is defined by acquiring minimal invasive access to the abdominal cavity through the body's natural openings like the mouth and stomach, anus, urethra and vagina. With the NOTES technique one can completely avoid incisions in the abdominal wall and thereby reduce the surgical trauma. The benefits of this technique is a reduction of postoperative pain, elimination of incisional hernias, prevention of wound infections, reduction of peritoneal adherence formation, achieving a faster recovery and a better cosmetic result [7,8].
The most documented and well-described way for gaining NOTES access to the abdominal cavity is through the vagina, transvaginal (TV). TV NOTES has mainly been used for cholecystectomy because of the direct line of vision to the upper abdomen and gallbladder that is achieved through this opening.
Compilation of results show that TV NOTES cholecystectomy can be implemented with low complication rates [20-22]. One retrospective case-control and one prospective observational study report less postoperative pain, reduced consumption of analgesics and faster recovery for TV NOTES compared to conventional laparoscopic cholecystectomy [23,24]. To date there are no systematic prospective randomized data on whether or not TV NOTES cholecystectomy leads to a better surgical outcome.
In the present study the postoperative course after TV NOTES cholecystectomy will be compared to laparoscopic cholecystectomy in a prospective randomized and blinded trial. The outcome of the randomization between the two surgical techniques will be blinded to patient and the nurse staff for the first 72 hours after the operation. The primary outcome parameter will be postoperative pain score during the first 24 hours. Secondary outcome parameters are postoperative pain score for the first 72 hours, fatigue, well-being, nausea, consumption of analgesics, complications, cosmetic result and sexual function.
The hypothesis being that TV NOTES cholecystectomy gives less postoperative pain, fatigue and nausea, a reduction in analgesics and a better cosmetic result and general well-being than conventional 4 port laparoscopic cholecystectomy.
详细描述
BACKGROUND:
Uncomplicated laparoscopic cholecystectomy will in most patients result in moderate to severe pain up until the first postoperative day. This will subside during the second and third postoperative day [1]. A feeling of low general well-being will also be present up until the first postoperative day and subside during the next couple of days [2].
To achieve faster recovery after laparoscopic interventions it has been shown that a reduction in the size of laparoscopic ports and thereby incisions can reduce postoperative pain [3,4]. Whether a further reduction of postoperative pain can be achieved by limiting the number of laparoscopic ports through the abdominal wall to a single one with Single Incision Laparoscopic Surgery (SILS) remains to be determined [5,6].
A new minimal invasive surgical technique is based on the principle of completely eliminating the use of ports through the abdominal wall. This new technique is called Natural Orifice Transluminal Endoscopic Surgery (NOTES) and is defined by acquiring minimal invasive access to the abdominal cavity through the body's natural openings like the mouth and stomach, anus, urethra and vagina. With the NOTES technique one can completely avoid incisions in the abdominal wall and thereby further reduce the surgical trauma. The benefits of this technique is a reduction of postoperative pain, elimination of incisional hernias, prevention of wound infections, reduction of peritoneal adherence formation, achieving a faster recovery and a better cosmetic result [7,8].
The most documented and well-described way for gaining NOTES access to the abdominal cavity is through the vagina, transvaginal (TV). There are several reasons for this. First of all the technique for gaining TV access to the abdominal cavity is already being used in gynaecology, where culdoscopy was first described in the literature nearly 100 years ago [9]. A diagnostic procedure for infertility that can be used in an outpatient setting [10-12]. Similarly, transvaginal ports have been used in gynaecology as a substitute for abdominal ports [13,14]. Thus there is already a well proven and established technique for obtaining transvaginal access to the abdominal cavity. Secondly it is easy to ensure a secure surgical closure of the point of entry under direct visualization with basic suturing instruments. And lastly the risk of contamination and infection is minimal when performing TV procedures [15].
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Booked for cholecystectomy due to symptomatic gallstones or gallstone induced mild pancreatitis.
- •Between 18 - 70 years old.
- •ASA classification I, II or III.
- •BMI < 30 kg/m
- •Written informed consent.
- •All of the inclusion criteria must be met before inclusion in the study.
排除标准
- •Expected poor compliance.
- •Previous cholecystitis or moderate to severe pancreatitis.
- •Culdotomy contraindicated.
- •Previous laparoscopic surgery or open surgery on vagina, uterus, fallopian tubes or ovaries. Except laparoscopic sterilisation.
- •Pregnancy or breastfeeding.
- •Daily consumption of any analgesic for one month prior to surgery or intermittent use of opioids.
- •Ongoing treatment with Monoamine Oxidase Inhibitors or Tricyclic antidepressants.
- •Known with any type of inflammatory bowel disease.
- •Known with chronic diseases that are known to cause pain sensations.
结局指标
主要结局
Cumulated postoperative pain with visual analogue scale (VAS)
时间窗: 72 hours
Postoperative pain will be measured with VAS, 3 hours after the operation as well as on the first, second and third postoperative day. Pain score will be assessed at rest and during mobilization from supine to erect posture. Based on these assesments a cumulated overall pain score for the first 72 postoperative hours will be calculated by adding the respective scores for each participant.
次要结局
- Postoperative complications(1 year)
- Cosmetic result(1 year)
- Postoperative well-being(72 hours)
- Postoperative analgesic and antiemetic consumption(72 hours)
- Postoperative fatigue(72 hours)
- Postoperative nausea(72 hours)
- Postoperative vomiting(72 hours)
- Sexual function and dyspareunia(1 year)
- Postoperative hospitalization(Until the individual participant is discharged from the hospital)
- Surgical details(Intra-operative)
- Early postoperative pain with VAS(24 hours)
- Late postoperative pain measured with VRS(48 hours)
- Early pain localization(24 hours)
- Late pain localization(48 hours)
研究者
Anders Meller Donatsky
MD, PhD-student
Herlev Hospital