NCT05934981Completed
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 148 (actual)
- First submitted
- 30 May 2023
- Start date
- 30 Aug 2023
- Primary completion date
- 20 Apr 2026
- Lead sponsor
- Bordeaux Colorectal Institute Academy
- Diseases
- Colorectal cancer
- NCT number
- NCT05934981
What you commit to
- Study type: Interventional
- Participants enrolled: 148
- From 30 Aug 2023 to the primary completion date, 20 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Procedure associated with colorectal surgery (except appendectomy or liver biopsy)
- VAS before surgery\> 3
- Emergency surgery
Other illness
- Crohn's disease, Hemorrhagic Rectocolitis (UC) with VAS \> 3
- ASA ≥ 3 (except if ASA 3 for non-cardiac and/or vascular diseases)
- History of laparotomy
- Pelvic Sepsis or Preoperative Fistula
- Persons undergoing psychiatric treatment without their consent
Other
- Laparotomy procedure
- Total or Subtotal Colectomy
- Transverse segmental colectomy
- Proctectomy with stoma or Total Coloproctectomy
- Patient with stoma
- Probable realization of a stoma during the operation
- Diverticulitis or Sigmoiditis with VAS \> 3
- Endometriosis with VAS \>3
- BMI ≥ 30
- 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 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Tivoli-Ducos - Bordeaux Colorectal Institute Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| HOPITAL NORD APHM - Service de Chirurgie Digestive Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.