Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

Last updated: July 31, 2025
Sponsor: Bordeaux Colorectal Institute Academy
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06154785
B.C.I.A 2023/01
  • Ages > 18
  • All Genders

Study Summary

The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years old

  • Colonic resection (right or left, subtotal or total) performed for benign ormalignant pathology

  • Rectal resection with or without stoma for benign or malignant pathology

  • Laparoscopic or robotic procedure

  • Surgery under low stable pressure pneumoperitoneum with AirSeal

  • Patient who benefits by medicare system

  • Oral agreement after reading information letter

Exclusion

Exclusion Criteria:

  • Laparotomy procedure

  • Associated resection (except appendectomy or liver biopsy)

  • Transverse colectomy

  • Emergency procedure

  • Pelvic sepsis

  • Pregnancy or breast feeding period

  • Legal incapacity or physical, psychological social or geographical statusinterfering with the patient's ability to agree to participate in the study

  • Persons deprived of liberty or under guardianship

Study Design

Total Participants: 300
Study Start date:
December 15, 2023
Estimated Completion Date:
September 30, 2025

Study Description

Laparoscopy is currently the gold standard for the vast majority of abdominal surgeries, and especially for colectomy for cancer or benign diseases. There are many data showing the benefits of the laparoscopic approach to colectomy in terms of morbidity, post-operative pain and analgesic consumption, length of hospital stay, cosmetic results, and improved patient satisfaction. In 2002, consensus European guidelines recommended insufflating at the lowest pressure that still provides sufficient exposure. Considering these results, low-pressure laparoscopy is one of the alternatives that have been developed to do away with the complications of the pneumoperitoneum while retaining its advantages.

However, other factors may influence the outcomes of the low-pressure pneumoperitoneum such as the use of humidification and warming gaz, robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall, ventilation-induced changes, and probably individual patient factors like obesity. These parameters could not be separately tested in randomized trial. We should consider all these parameters in a prospective international registry in order to optimize the benefit of low-pressure pneumoperitoneum in post-operative recovery.

Connect with a study center

  • El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"

    Buenos-Aires, Bueno-Aires C1000
    Argentina

    Site Not Available

  • Universitair Ziekenhuis

    Jette, Bruxelles 1090
    Belgium

    Active - Recruiting

  • Hôpital Jean Minoz

    Besançon, 25030
    France

    Site Not Available

  • Clinique Tivoli-Ducos - Bordeaux Colorectal Institute

    Bordeaux, 33 000
    France

    Active - Recruiting

  • Hôpital Albert Michallon

    La Tronche, 38700
    France

    Site Not Available

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • Hôpital Nord-Marseille

    Marseille, 13915
    France

    Active - Recruiting

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris, 75908
    France

    Site Not Available

  • Hôpital Saint-Antoine

    Paris, 75012
    France

    Site Not Available

  • Hôpital Lyon Sud

    Pierre benite, 69495
    France

    Active - Recruiting

  • Hopital Charles Nicolle

    Rouen, 76031
    France

    Active - Recruiting

  • St. Georg Klinikum Eisenach

    Eisenach, 99817
    Germany

    Site Not Available

  • Division of Colon and Rectal Surgery

    Milan, 20089
    Italy

    Active - Recruiting

  • Academic Medical Center

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Hospital General Universitario Gregorio

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hôpitaux Universitaires de Genève

    Geneve, 1205
    Switzerland

    Active - Recruiting

  • Nhs Fundation Trust

    Manchester, M139WL
    United Kingdom

    Site Not Available

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