Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
NCT05934981
Summary
To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F \& 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation. A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.
Eligibility
Inclusion Criteria: * Colorectal surgery for malignant or benign pathology * Surgery without stoma * Patient operable by laparoscopy or robot assisted under low pressure pneumoperitoneum * Age ≥ 18 years old * Patient affiliated to a social security system or beneficiary of the same * Informing the patient and obtaining free, informed, and written consent, signed by the patient and his investigator. Exclusion Criteria: * Laparotomy procedure * Total or Subtotal Colectomy * Transverse segmental colectomy * Proctectomy with stoma or Total Coloproctectomy * Procedure associated with colorectal surgery (except appendectomy or liver biopsy) * Patient with stoma * Probable realization of a stoma during the operation * Crohn's disease, Hemorrhagic Rectocolitis (UC) with VAS \> 3 * Diverticulitis or Sigmoiditis with VAS \> 3 * Endometriosis with VAS \>3 * VAS before surgery\> 3 * BMI ≥ 30 * ASA ≥ 3 (except if ASA 3 for non-cardiac and/or vascular diseases) * History of laparotomy * Emergency surgery * Pelvic Sepsis or Preoperative Fistula * Pregnant woman, likely to be, or breastfeeding * Persons deprived of their liberty or under measure of judicial protection (curators or guardianship) or unable to give their consent * Persons undergoing psychiatric treatment without their consent * Persons admitted to a health or social establishment for purposes other than research * Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons
Conditions3
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT05934981