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Spots Global Cancer Trial Database for Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

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Trial Identification

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

Interventions

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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