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Clinical Trials in France / NCT06154785
Recruiting Observational

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

NCT06154785 · tracked via the Priya Life Science France tracker
Sponsor
Bordeaux Colorectal Institute Academy
Phase
Observational
Started
2023-12-15
Last updated
2025-08-01

Condition(s) studied

Colorectal SurgeryBenign or Malignant Rectal or Colon Tumors

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years old * Colonic resection (right or left, subtotal or total) performed for benign or malignant 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 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 status interfering with the patient's ability to agree to participate in the study * Persons deprived of liberty or under guardianship

Primary outcome measure(s)

  • To assess the impact of the stable low-pressure approach (using Airseal Insufflator) and its associated parameters into the the early rehabilitation program after colorectal surgery on length of stay. — From the surgery to the end of the hospitalization (max 30 days)
    Evaluate the Length of hospital stay after colorectal surgery.

Trial sites (18)

FacilityCityRegionStatus
Universitair Ziekenhuis Jette Brussels Capital Recruiting
Hôpital Jean Minoz Besançon France Not Yet Recruiting
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute Bordeaux France Recruiting
Hôpital Albert Michallon La Tronche France Not Yet Recruiting
Hôpital Bicêtre Le Kremlin-Bicêtre France Not Yet Recruiting
Hôpital Nord-Marseille Marseille France Recruiting
Clinique Hartmann Neuilly-sur-Seine France Not Yet Recruiting
Hopital Saint-Louis Paris France Not Yet Recruiting
Hôpital Saint-Antoine Paris France Not Yet Recruiting
Hôpital Européen Georges Pompidou Paris France Not Yet Recruiting
Hôpital Lyon Sud Pierre-Bénite France Recruiting
Hopital Charles Nicolle Rouen France Recruiting
St. Georg Klinikum Eisenach Eisenach Germany Not Yet Recruiting
Division of Colon and Rectal Surgery Milan Italy Recruiting
Academic Medical Center Amsterdam Netherlands Recruiting
Hospital General Universitario Gregorio Madrid Spain Recruiting
Hôpitaux Universitaires de Genève Geneva Switzerland Recruiting
Nhs Fundation Trust Manchester United Kingdom Not Yet Recruiting

Other trials for the same condition

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery Recruiting
Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21) Recruiting
Study of Postoperative Ileus in Digestive Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06154785 on ClinicalTrials.gov ↗ ← All trials in France