Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxi… (NCT05934981) | Clinical Trial Compass
CompletedNot Applicable
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
France148 participantsStarted 2023-08-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).