Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
NCT05934981
Benign or Malignant Rectal or Colon Tumors, Colonic Diseases
Bordeaux, France
View Trial DetailsNCT Number: NCT06154785
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.
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Request Info18 year and older
All sexes
Observational
Universitair Ziekenhuis, Jette, Brussels Capital, Belgium
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From the surgery to the end of the hospitalization (max 30 days)
Evaluate the Length of hospital stay after colorectal surgery.
Time frame: 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))
Time frame: From the surgery to the end of the hospitalization (max 30 days)
Evaluate the impact on the opioid consumption after colorectal surgery;
Time frame: From the surgery to the end of the hospitalization (max 30 days)
Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery
Time frame: From the surgery to the end of the hospitalization (max 30 days)
Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification
Time frame: 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
Time frame: At 30 days after the end of the surgery
Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification
Contact information is provided by the study sponsor or research team.
Hélène HMM MAILLOU-MARTINAUD
CONTACT
Quentin QD DENOST, Prof
CONTACT
Bordeaux Colorectal Institute Academy
Other
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
Acronym: CROSS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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