Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone
Bordeaux Colorectal Institute Academy
148 participants
Aug 30, 2023
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria21
- 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
Interventions
low pressure pneumoperitoneum (5-8mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.
low pressure pneumoperitoneum (5-8mmHg), and use standard room temperature with dry insufflation.
Locations(2)
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NCT05934981