Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute
RECRUITING
Bordeaux
HOPITAL NORD APHM - Service de Chirurgie Digestive
RECRUITING
Marseille
Contact Information
Primary
Quentin DENOST, Prof
q.denost@bordeaux-colorectal-institute.fr
+33 (0)5.47.50.15.75
Backup
Stéphanie GUILLON
s.guillon@bordeaux-colorectal-institute.fr
+33 (0)5.47.50.15.75
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 148
Treatments
Experimental: Low Pressure and warm and humidified CO2 insufflation
Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation
Active_comparator: Low Pressure
Low pressure pneumoperitoneum
Related Therapeutic Areas
Sponsors
Leads: Bordeaux Colorectal Institute Academy

This content was sourced from clinicaltrials.gov

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