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Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation

NCT05934981 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Colorectal Surgery
  • Benign or Malignant Rectal or Colon Tumors

Interventions

PROCEDURE

Laparoscopic 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.

PROCEDURE

Laparoscopic surgery under low pressure and conventional Insufflation

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

Sponsors & Collaborators

  • Bordeaux Colorectal Institute Academy

    lead OTHER

Principal Investigators

  • Quentin DENOST · Bordeaux Colorectal Institute Academy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05934981 on ClinicalTrials.gov