Clinical trial NCT06154785: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Surgery
Benign or Malignant Rectal or Colon Tumors
Keywords: colorectal pathology
low stable pressure
laparoscopic
length hospital stay
Lead sponsor: Bordeaux Colorectal Institute Academy
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cohort study is a pilot study assessing the best operative association with stable low-pressure pneumoperitoneum in order to optimize postoperative outcomes after mini-invasive colorectal surgery. The use of robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall and ventilation-parameters could not be separately tested in randomized trial.

In this pilot study, we aim to include 300 patients with low stable pneumoperitoneum with Colorectal surgery.

All patient assessements will be done according to the sites standard of care.

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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: From the surgery to the end of the hospitalization (max 30 days)
Secondary outcomes:
measure: The impact of stable low pressure on the postoperative pain after colorectal surgery
timeFrame: At 24 hours after the end of the surgery
measure: The impact of stable low pressure on the opioid consumption after colorectal surgery
timeFrame: From the surgery to the end of the hospitalization (max 30 days)
measure: The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure
timeFrame: From the surgery to the end of the hospitalization (max 30 days)
measure: The Post-operative Surgical and Medical morbidity
timeFrame: From the surgery to the end of the hospitalization (max 30 days)
measure: The impact of the anesthetic management on the feasibility and benefit of low stable pressure
timeFrame: From the surgery to the end of the hospitalization (max 30 days)
measure: The Surgical and Medical morbidity at 30 days
timeFrame: At 30 days after the end of the surgery
Other outcomes:
Locations:
city: Buenos-Aires
country: Argentina
facility: El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"
state: Bueno-Aires
city: Jette
country: Belgium
facility: Universitair Ziekenhuis
state: Bruxelles
city: Besançon
country: France
facility: Hôpital Jean Minoz
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
city: La Tronche
country: France
facility: Hôpital Albert Michallon
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Marseille
country: France
facility: Hôpital Nord-Marseille
city: Neuilly-sur-Seine
country: France
facility: Clinique Hartmann
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Pierre benite
country: France
facility: Hôpital Lyon Sud
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Eisenach
country: Germany
facility: St. Georg Klinikum Eisenach
city: Milan
country: Italy
facility: Division of Colon and Rectal Surgery
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Manchester
country: United Kingdom
facility: Nhs Fundation Trust
Study officials:
References: