Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
- Conditions
- Colorectal SurgeryBenign or Malignant Rectal or Colon Tumors
- Registration Number
- NCT06154785
- Lead Sponsor
- Bordeaux Colorectal Institute Academy
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Age ≥ 18 years old
- Colonic resection (right or left) performed for benign or malignant pathology
- Partial or Total mesorectal Excision (PME or TME) 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the impact of the stable low-pressure approach (using Airseal Insufflator) and its associated parameters into the the early rehabilitation program after colorectal surgery on length of stay. From the surgery to the end of the hospitalization (max 30 days) Evaluate the Length of hospital stay after colorectal surgery.
- Secondary Outcome Measures
Name Time Method The impact of the anesthetic management on the feasibility and benefit of low stable pressure From the surgery to the end of the hospitalization (max 30 days) Evaluate the impact of drugs, deep neuromuscular blockade, ventilation characteristics, intraoperative nociception monitoring, patient positioning, pre-stretching of the abdominal wall, and individual patient factors
The impact of stable low pressure on the postoperative pain after colorectal surgery At 24 hours after the end of the surgery Pain is evaluated (Visual Analgesic Scale (Vas scores from 0 (no pain) to 10 (hurst worst))
The Post-operative Surgical and Medical morbidity From the surgery to the end of the hospitalization (max 30 days) Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification
The impact of stable low pressure on the opioid consumption after colorectal surgery From the surgery to the end of the hospitalization (max 30 days) Evaluate the impact on the opioid consumption after colorectal surgery;
The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure From the surgery to the end of the hospitalization (max 30 days) Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery
The Surgical and Medical morbidity at 30 days At 30 days after the end of the surgery Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification
Trial Locations
- Locations (19)
Division of Colon and Rectal Surgery
🇮🇹Milan, Italy
Hôpital Saint-Antoine
🇫🇷Paris, France
Hôpital Nord-Marseille
🇫🇷Marseille, France
Clinique Hartmann
🇫🇷Neuilly-sur-Seine, France
Hôpital Lyon Sud
🇫🇷Pierre benite, France
Academic Medical Center
🇳🇱Amsterdam, Netherlands
El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"
🇦🇷Buenos-Aires, Bueno-Aires, Argentina
Universitair Ziekenhuis
🇧🇪Jette, Bruxelles, Belgium
St. Georg Klinikum Eisenach
🇩🇪Eisenach, Germany
Hopital Saint-Louis
🇫🇷Paris, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital Jean Minoz
🇫🇷Besançon, France
Hôpital Albert Michallon
🇫🇷La Tronche, France
Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
🇫🇷Bordeaux, France
Hopital Charles Nicolle
🇫🇷Rouen, France
Hospital General Universitario Gregorio
🇪🇸Madrid, Spain
Nhs Fundation Trust
🇬🇧Manchester, United Kingdom
Hôpitaux Universitaires de Genève
🇨🇭Geneve, Switzerland