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

NCT05934981 | Recruiting

• 1 other identifier: BCIA 2022/01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

colorectal pathology; laparoscopic; low pressure; early postoperative rehabilitation

Outcome Measures

Primary Outcomes (1)

• Number of patients with pain at 24 hours after the end of the intervention by VAS ≤ 3 without taking opioids (without step 2 and step 3 analgesics).

  Pain is evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)

  At 24 hours after the end of surgery

Secondary Outcomes (15)

• Operating time

  During surgery

• Conversion rate in normal pressure and laparotomy

  During surgery

• Peri-operative Heart Rate

  During surgery

• Perioperative arterial blood pressure

  During surgery

• Peri-operative temperature variations

  During surgery

Study Arms (2)

Low Pressure and warm and humidified CO2 insufflation

EXPERIMENTAL

Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation

Procedure: Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation

Low Pressure

ACTIVE COMPARATOR

Low pressure pneumoperitoneum

Procedure: Laparoscopic surgery under low pressure and conventional Insufflation

Interventions

Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation PROCEDURE

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

Low Pressure and warm and humidified CO2 insufflation

Laparoscopic surgery under low pressure and conventional Insufflation PROCEDURE

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

Low Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Probable realization of a stoma during the operation
• Crohn's disease, Hemorrhagic Rectocolitis (UC) with VAS \> 3
• Diverticulitis or Sigmoiditis with VAS \> 3
• Endometriosis with VAS \>3
• VAS before surgery\> 3
• BMI ≥ 30
• ASA ≥ 3 (except if ASA 3 for non-cardiac and/or vascular diseases)
• History of laparotomy
• Emergency surgery

Sponsors & Collaborators

• Bordeaux Colorectal Institute Academy: lead

Study Sites (2)

Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute

Bordeaux, France

RECRUITING

HOPITAL NORD APHM - Service de Chirurgie Digestive

Marseille, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Quentin DENOST

  Bordeaux Colorectal Institute Academy

  STUDY DIRECTOR

Central Study Contacts

Quentin DENOST, Prof

CONTACT

+33 (0)5.47.50.15.75; q.denost@bordeaux-colorectal-institute.fr

Stéphanie GUILLON

CONTACT

+33 (0)5.47.50.15.75; s.guillon@bordeaux-colorectal-institute.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 7, 2023
• Study Start: August 30, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)