Actively Recruiting
Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone
Led by Bordeaux Colorectal Institute Academy · Updated on 2025-09-12
148
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of using low-pressure pneumoperitoneum combined with warm and humidified carbon dioxide gas during laparoscopic colorectal surgery. This approach aims to reduce post-operative pain without the use of opioid painkillers. The trial compares this method to the standard low-pressure laparoscopy using cold and dry gas in patients undergoing colorectal surgeries for benign or malignant conditions. Participants receive one of two treatments during surgery: either low-pressure pneumoperitoneum with warm (35°C), humidified (95% relative humidity) CO2 gas or low-pressure pneumoperitoneum with standard room temperature, dry CO2 gas. The low pressure used is between 5 and 8 mmHg. This trial is double-blind and randomized to fairly assess the impact of these two approaches on post-operative recovery. During the study, participants will be closely monitored for pain levels 24 hours after surgery using a visual analog scale (VAS) without opioid use. Additional assessments include surgery length, heart rate, blood pressure, temperature changes, inflammation markers, bowel function recovery, surgical complications, hospital stay duration, quality of life, and analgesic use up to 30 days after surgery. Follow-up extends to three months for longer-term outcomes related to pain, opioid use, and recovery.
CONDITIONS
Brief 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 under low pressure pneumoperitoneum
- Age 18 years or older
- Patient affiliated to a social security system or beneficiary of the same
- Informed, free, and written consent obtained from patient and investigator
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 stoma creation during operation
- Crohn's disease or hemorrhagic rectocolitis with pain score above 3
- Diverticulitis or sigmoiditis with pain score above 3
- Endometriosis with pain score above 3
- Pain score above 3 before surgery
- Body mass index 30 or higher
- ASA physical status 3 or higher except for non-cardiac or vascular diseases
- History of laparotomy
- Emergency surgery
- Pelvic sepsis or preoperative fistula
- Pregnant, likely to be pregnant, or breastfeeding women
- Persons deprived of liberty or under judicial protection
- Persons undergoing psychiatric treatment without consent
- Persons admitted to health or social establishment for non-research reasons
- Inability to undergo medical monitoring for geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo laparoscopic colorectal surgery using low pressure pneumoperitoneum with either warm and humidified CO2 insufflation or conventional dry CO2 insufflation.
1 surgery visit and hospital stay up to 30 days
Duration - Up to 3 months after surgery
Participants are monitored for recovery including pain levels, analgesic use, complications, and quality of life for up to 3 months after surgery.
Visits during hospitalization and follow-up assessments up to 3 months
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
S
Stéphanie GUILLON
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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