Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Specific pain (shoulders and/or subcostal areas) related to the laparoscopic surgery (Day 0), measured with a numerical pain assessment scale (score from 0 to 10)
研究概览
简要总结
This is a phase III, monocenter and randomized study, which evaluates the effectiveness of peritoneal gas drainage on postoperative pain in laparoscopic or robotic laparoscopic gynaecological surgery. This study aim is to assess the efficacy of active gas extraction with a drain (arm A) in comparison to manual evacuation (arm B,) in terms of pain incidence reduction linked to laparoscopic or robotic laparoscopic surgery.
详细描述
The primary objective is to assess the efficacy of active gas aspiration compared to simple manual gas evacuation to reduce the incidence of specific laparoscopic surgery pain.
Secondary objectives of this study include :
- Comparing the evolution of specific pains after laparoscopic surgery, between study groups
- Description of postoperative antalgics consumption in each group
- Evaluating the safety of the evaluated procedure
- Evaluating the impact of the evaluated procedure on hospitalisation duration ( for patients with ambulatory surgery initially planned)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 ans ;
- •Woman who underwent laparoscopic or robotised laparoscopic surgery in peritoneal cavity (benign or malignant gynaecological affection) ;
- •Planned ambulatory surgery
- •Patient willing and able to be treated and followed according the protocol during the trial ;
- •Patient covered by the French "Social Security" regime ;
- •Effective contraception for reproductive age patients ;
- •Signed written informed consent before surgery
- •Per-operatory eligibility criterion :
- •No conversion from laparoscopic surgery to laparotomy surgery
排除标准
- •Extra-peritoneal surgery scheduled ( example : aortic dissection) ;
- •Upper-abdomen surgery (example : liver, gall bladder) ;
- •History of shoulders pains prior to surgery (the assessment must be carried out within a period of 30 days before the surgery) ;
- •Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
- •Person under guardianship
- •Pregnant or breastfeeding woman
- •Non eligibility criterion known during the operation :
- •Conversion from laparoscopic surgery to laparotomy surgery
研究组 & 干预措施
Arm A :Aspiration of peritoneal gas through a drain
Patients in experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out by a drain.
Then, patients will be followed-up during 7 days after surgery.
干预措施: Drain (Procedure)
Arm B : Manual evacuation of the peritoneal gas, via the trocar
Laparoscopic or robotised laparoscopic surgery + Trocar
Patient in this experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out carried out manually using the trocar (standard of care).Then, patient will be followed-up during 7 days after surgery.
干预措施: Manual exsufflation (Procedure)
结局指标
主要结局
Specific pain (shoulders and/or subcostal areas) related to the laparoscopic surgery (Day 0), measured with a numerical pain assessment scale (score from 0 to 10)
时间窗: During the 24 hours after surgery
Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests).
次要结局
- Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10)(24 hours after surgery)
- Adverse events (AE) (grade ≥III Clavien-Dindo classification)(30 days after surgery)
- Evaluate the impact of the evaluated procedure on the hospitalisation duration(Through the study patient participation, an average of 2 months)
- Assess pain at trocar holes comparatively in the two groups(24 hours after surgery)
- Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10)(7 days after surgery)
- Antalgics consumption(24 hours and 7 days after surgery)