Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
Recruiting now
Conditions studied: Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors
In brief
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.
Key facts
- Study ID
- NCT06154785
- Run by
- Bordeaux Colorectal Institute Academy
- People needed
- 300
- Starts
- 2023-12-15
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2025-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hôpital Nord-Marseille — Marseille, France (enrolling)
- Hôpital Lyon Sud — Pierre-Bénite, France (enrolling)
- Hopital Charles Nicolle — Rouen, France (enrolling)
- Clinique Tivoli-Ducos - Bordeaux Colorectal Institute — Bordeaux, France (enrolling)
- Division of Colon and Rectal Surgery — Milan, Italy (enrolling)
- Academic Medical Center — Amsterdam, Netherlands (enrolling)
- Hospital General Universitario Gregorio — Madrid, Spain (enrolling)
- Hôpitaux Universitaires de Genève — Geneva, Switzerland (enrolling)
- Universitair Ziekenhuis — Jette, Brussels Capital, Belgium (enrolling)
- Nhs Fundation Trust — Manchester, United Kingdom
- Hôpital Jean Minoz — Besançon, France
- Hôpital Albert Michallon — La Tronche, France
- Hôpital Bicêtre — Le Kremlin-Bicêtre, France
- Clinique Hartmann — Neuilly-sur-Seine, France
- Hopital Saint-Louis — Paris, France
- Hôpital Saint-Antoine — Paris, France
- Hôpital Européen Georges Pompidou — Paris, France
- St. Georg Klinikum Eisenach — Eisenach, Germany
Full record on ClinicalTrials.gov
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