RecruitingNCT06154785

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)


Sponsor

Bordeaux Colorectal Institute Academy

Enrollment

300 participants

Start Date

Dec 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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

Locations(18)

Universitair Ziekenhuis

Jette, Brussels Capital, Belgium

Hôpital Jean Minoz

Besançon, France

Clinique Tivoli-Ducos - Bordeaux Colorectal Institute

Bordeaux, France

Hôpital Albert Michallon

La Tronche, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Hôpital Nord-Marseille

Marseille, France

Clinique Hartmann

Neuilly-sur-Seine, France

Hopital Saint-Louis

Paris, France

Hôpital Saint-Antoine

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Hôpital Lyon Sud

Pierre-Bénite, France

Hopital Charles Nicolle

Rouen, France

St. Georg Klinikum Eisenach

Eisenach, Germany

Division of Colon and Rectal Surgery

Milan, Italy

Academic Medical Center

Amsterdam, Netherlands

Hospital General Universitario Gregorio

Madrid, Spain

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Nhs Fundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06154785


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