RecruitingNot ApplicableNCT05934981

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


Sponsor

Bordeaux Colorectal Institute Academy

Enrollment

148 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using warm, humidified carbon dioxide gas at low pressure during laparoscopic (keyhole) colorectal surgery reduces pain, preserves body temperature, and speeds recovery compared to standard cold, dry gas at higher pressure. **You may be eligible if...** - You are 18 or older - You are scheduled for laparoscopic or robot-assisted colorectal surgery for a cancerous or benign condition - Your surgery does not require a stoma (colostomy bag) - You can consent to participate and are affiliated with a social security system **You may NOT be eligible if...** - Your surgery requires an open (non-laparoscopic) approach - You need a total or subtotal colectomy or transverse colectomy - You need a proctectomy with stoma or total coloproctectomy - You already have or are likely to need a stoma - Your procedure involves additional complex surgeries beyond the colorectal operation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic surgery under low pressure and warm and humidified CO2 Insufflation

low pressure pneumoperitoneum (5-8mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.

PROCEDURELaparoscopic surgery under low pressure and conventional Insufflation

low pressure pneumoperitoneum (5-8mmHg), and use standard room temperature with dry insufflation.


Locations(2)

Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute

Bordeaux, France

HOPITAL NORD APHM - Service de Chirurgie Digestive

Marseille, France

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NCT05934981


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