Actively Recruiting
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
Led by Bordeaux Colorectal Institute Academy · Updated on 2025-09-12
148
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Colorectal surgery for malignant or benign pathology
- Surgery without stoma
- Patient operable by laparoscopy or robot-assisted surgery under low-pressure pneumoperitoneum
- Age 18 years or older
- Patient affiliated to a social security system or beneficiary of the same
- Patient informed and has given free, informed, and written consent
You will not qualify if you...
- 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 or probable realization of stoma during operation
- Crohn's disease, hemorrhagic rectocolitis, diverticulitis, sigmoiditis, or endometriosis with pain score VAS > 3
- Pain score VAS greater than 3 before surgery
- Body mass index (BMI) 30 or higher
- ASA score 3 or higher 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 pregnant, or breastfeeding
- Persons deprived of liberty, under judicial protection, or unable to give consent
- Persons undergoing psychiatric treatment without consent
- Persons admitted to health or social establishments for reasons other than research
- Inability to undergo medical monitoring of the trial for geographic, social, or psychological reasons
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Trial Site Locations
Total: 2 locations
1
Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute
Bordeaux, France
Actively Recruiting
2
HOPITAL NORD APHM - Service de Chirurgie Digestive
Marseille, France
Actively Recruiting
Research Team
Q
Quentin DENOST, Prof
CONTACT
S
Stéphanie GUILLON
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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