The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Pressure of Pneumoperitoneum and Trendelenburg Inclination Angle During the Surgery: A Novel Perspective for Patient Safety
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).
研究概览
简要总结
This RCT aims to investigate the real surgical effects of MBP prior to the gynecological laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest Trendelenburg inclination angle, the ease of the surgical view and the preferences of the patients with objective measures.
详细描述
Mechanical bowel preparation (MBP) has been routinely used prior to minimally invasive gynaecologic procedures (MIGP) hypothetically to improve intraoperative bowel handling and visualization of the surgical field, and also to reduce faecal contamination in the setting of bowel injury and/or resection.
The studies investigating the effect of MBP on MIGP are limited and most of existing data are extrapolated from the reports of colorectal and urological surgery studies.
Besides, evaluation of the surgical workspace visualization and intraoperative bowel handling are far from being objective since they were mostly measured by a 4/5/10-point Likert scales or rated verbally on scales of excellent to poor by the operating surgeons.
In contrary, it is planned to use objective visualize index, and objective surgical conditions to measure whether MBP has any effect or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Surgeons and the assessor will be blind. The nurse working in the gynecology setting perform the intervention to the previously randomized patients. Patient will be told for not to reveal the intervention that she undergoes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years and older
- •Able to provide informed consent
- •Undergo laparoscopic gynecological surgery for a benign condition
排除标准
- •History of previous abdominal surgery
- •Clinically significant present or past systemic diseases
- •Inability to perform mechanical bowel preparation
- •Suspicion of malignancy
- •Association with non-gynaecological surgical pathologies
- •Severe endometriosis (stage ≥ III according to the classification of the American Society for Reproductive Medicine)
- •Psychiatric disorders precluding consent
结局指标
主要结局
The lowest pneumoperitoneum pressure (PP) at standard Trendelenburg inclination angle (TIA).
时间窗: In the initial phase of the surgery
The PP will be increased to 15 mmHg while keeping the TIA same, at 30o. The surgeon will displace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel was displaced out of the pelvis, the PP will be stepwise decreased by 1 mmHg during 1 min intervals to the lowest pressure where the bowel is to descend towards the pelvis over the pelvic brim and/or where the surgical workspace is not adequate to proceed safely with the planned operation. This value will be recorded as the lowest PP adequate to proceed safely with the planned surgery at standard TIA (30 degree).
The surgical visibility of abdomen
时间窗: After the introduce of first left lateral port
A scale title as "Objective Visual Indexing (OVI)" will be used for assessing the visibility of the Douglas pouch and adnexa. The assessment of the visibility of Douglas pouch and adnexa will be performed under standard pneumoperitoneum pressure (12mmHg) and Trendelenburg inclincation angle (30). After the first Inspection, scale of VI scoring will be calculated by adding up the points obtained from optical inspection. Higher scores mean better visuality of the surgical field.
The lowest Trendelenburg inclination angle (TIA) at standard pneumoperitoneum pressure (PP) adequate to proceed with the planned operation.
时间窗: In the initial phase of the surgery
The PP obtained in outcome 2 will be readjusted to the standard 12 mmHg keeping the TIA same, at 300. Then, the surgeon will replace the bowel beginning from the cecum followed by the last ileal loop above the sacral promontory. Once the bowel is displaced out of the pelvis, the TIA will be gradually decreased by 1o with 15 seconds intervals to the degree where the bowel is to descend towards the pelvis over the pelvic brim. This value will be recorded as the lowest TIA adequate to proceed safely with the planned surgery at standard PP (12 mmHg).
次要结局
- Preoperative patient symptomatology(Right before the surgery)
- Complications(At 1st week and 6th week postoperatively or whenever it occurred.)
- Postoperative pain(at 24th hours)
研究者
Kadir Bakay
Associate Professor
Ondokuz Mayıs University