Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
- Conditions
- Colorectal SurgeryBenign or Malignant Rectal or Colon Tumors
- Registration Number
- NCT05934981
- Lead Sponsor
- Bordeaux Colorectal Institute Academy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 148
Inclusion Criteria:<br><br> - Colorectal surgery for malignant or benign pathology<br><br> - Surgery without stoma<br><br> - Patient operable by laparoscopy or robot assisted under low pressure<br> pneumoperitoneum<br><br> - Age = 18 years old<br><br> - Patient affiliated to a social security system or beneficiary of the same<br><br> - Informing the patient and obtaining free, informed, and written consent, signed by<br> the patient and his investigator.<br><br>Exclusion Criteria:<br><br> - Laparotomy procedure<br><br> - Total or Subtotal Colectomy<br><br> - Transverse segmental colectomy<br><br> - Proctectomy with stoma or Total Coloproctectomy<br><br> - Procedure associated with colorectal surgery (except appendectomy or liver biopsy)<br><br> - Patient with stoma<br><br> - Probable realization of a stoma during the operation<br><br> - Crohn's disease, Hemorrhagic Rectocolitis (UC)<br><br> - Sigmoiditis<br><br> - VAS before surgery> 3<br><br> - BMI = 30<br><br> - ASA = 3<br><br> - History of laparotomy<br><br> - Emergency surgery<br><br> - Pelvic Sepsis or Preoperative Fistula<br><br> - Pregnant woman, likely to be, or breastfeeding<br><br> - Persons deprived of their liberty or under measure of judicial protection (curators<br> or guardianship) or unable to give their consent<br><br> - Persons undergoing psychiatric treatment without their consent<br><br> - Persons admitted to a health or social establishment for purposes other than<br> research<br><br> - Inability to undergo medical monitoring of the trial for geographic, social or<br> psychological reasons
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients with pain at 24 hours after the end of the intervention by VAS = 3 without taking opioids (without step 2 and step 3 analgesics).
- Secondary Outcome Measures
Name Time Method Operating time;Conversion rate in normal pressure and laparotomy;Peri-operative Heart Rate;Perioperative arterial blood pressure;Peri-operative temperature variations;Rate of c-reactive protein;Time to bowel opening and passage of gas;Number of patients with medical and/or surgical morbidity;Number of patients with R0 resection;Length of stay in hospital;Number of patients with pain at 30 days;Number of patients taking analgesics until 30 days;Mean Score of the EQ-5D-5L Quality of Life;Evaluation of predictive factors of postoperative pain;Evaluation of predictive factors of opioid intake