Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
Status: Recruiting
Location: See all (18) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 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
Locations
Other Locations
Belgium
Universitair Ziekenhuis
RECRUITING
Jette
France
Hôpital Jean Minoz
NOT_YET_RECRUITING
Besançon
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
RECRUITING
Bordeaux
Hôpital Albert Michallon
NOT_YET_RECRUITING
La Tronche
Hôpital Bicêtre
NOT_YET_RECRUITING
Le Kremlin-bicêtre
Hôpital Nord-Marseille
RECRUITING
Marseille
Clinique Hartmann
NOT_YET_RECRUITING
Neuilly-sur-seine
Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
Hôpital Saint-Antoine
NOT_YET_RECRUITING
Paris
Hopital Saint-Louis
NOT_YET_RECRUITING
Paris
Hôpital Lyon Sud
RECRUITING
Pierre-bénite
Hopital Charles Nicolle
RECRUITING
Rouen
Germany
St. Georg Klinikum Eisenach
NOT_YET_RECRUITING
Eisenach
Italy
Division of Colon and Rectal Surgery
RECRUITING
Milan
Netherlands
Academic Medical Center
RECRUITING
Amsterdam
Spain
Hospital General Universitario Gregorio
RECRUITING
Madrid
Switzerland
Hôpitaux Universitaires de Genève
RECRUITING
Geneva
United Kingdom
Nhs Fundation Trust
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
Quentin QD DENOST, Prof
q.denost@bordeaux-colorectal-institute.fr
+33(0)5 47 50 15 75
Backup
Hélène HMM MAILLOU-MARTINAUD
h.maillou.martinaud@bordeaux-colorectal-institute.fr
+ 33 (0)6 68 68 68 05
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2025-09
Participants
Target number of participants: 300
Treatments
International cohort
This is an international cohort (France and other international centers) which consists of including patients undergoing colorectal surgery performed at low pressure for benign or malignant pathology.This stage 2b cohort study is a pilot study assessing the best operative association with stable low-pressure pneumoperitoneum in order to optimize postoperative outcomes after mini invasive colorectal surgery.
Related Therapeutic Areas
Sponsors
Leads: Bordeaux Colorectal Institute Academy