Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The theoretical hospital stay
研究概览
简要总结
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colic lesion justifying surgical resection by segmental colectomy,
- •Surgery proposed by laparoscopy,
- •Body mass index (BMI) ≤30 kg/m2,
- •Written informed consent signed by the patient,
- •Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen.
排除标准
- •Probable realization of a stoma during the procedure,
- •Robot-assisted approach,
- •Contraindication to laparoscopic surgery,
- •Pregnant or likely to be pregnant,
- •Patient deprived of liberty or placed under the authority of a tutor,
- •Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
研究组 & 干预措施
Conventional laparoscopy
Laparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator.
干预措施: Conventional pressure laparoscopy (Procedure)
Low pressure laparoscopy
Laparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal®
干预措施: Low pressure laparoscopy (Procedure)
结局指标
主要结局
The theoretical hospital stay
时间窗: from hospitalization day until hospital discharge, assessed up to 15 days
The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria)
次要结局
- Intestinal transit recovery time frame(From surgery to transit recovery assessed up to 15 days)
- Nausea and vomiting incidence(From surgery to hospital discharge assessed up to 15 days)
- Short Form Health (SF12) score(20 days and 3 months post surgery)
- Pain score using self-report pain assessment tool (EVA)(From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery)
- Real hospitalization duration(From hospitalization day until hospital discharge assessed up to 15 days)
- Rehospitalization number(from hospital discharge assessed up to 15 days to 3 months post surgery)
- Differential cost of patient care(From surgery to hospital discharge assessed up to 15 days)
- Morbidity rate(20 days post surgery)
- Mortality rate(20 days post surgery)
- GastroIntestinal-Quality-of-Life Index (GIQLI)(20 days and 3 months post surgery)
- Analgesic treatment incidence(From surgery to 3 months post surgery)