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Brief Title: Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
Official Title: Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
Study ID: NCT06154785
Brief 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.
Detailed 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno", Buenos-Aires, Bueno-Aires, Argentina
Universitair Ziekenhuis, Jette, Bruxelles, 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 benite, , 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, Geneve, , Switzerland
Nhs Fundation Trust, Manchester, , United Kingdom