Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

Colorectal Surgery Clinical Trial

— CROSS  

Official title:

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154785
• Other study ID #: B.C.I.A 2023/01
• Status: Recruiting
• Start date: December 15, 2023
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: Bordeaux Colorectal Institute Academy
• Contact: Quentin QD DENOST, Prof
• Phone: +33(0)5 47 50 15 75
• Email: q.denost[@]bordeaux-colorectal-institute.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• Pneumoperitoneum

Locations

Country	Name	City	State
Argentina	El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"	Buenos-Aires	Bueno-Aires
Belgium	Universitair Ziekenhuis	Jette	Bruxelles
France	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	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Saint-Antoine	Paris
France	Hopital Saint-Louis	Paris
France	Hôpital Lyon Sud	Pierre benite
France	Hopital Charles Nicolle	Rouen
Germany	St. Georg Klinikum Eisenach	Eisenach
Italy	Division of Colon and Rectal Surgery	Milan
Netherlands	Academic Medical Center	Amsterdam
Spain	Hospital General Universitario Gregorio	Madrid
Switzerland	Hôpitaux Universitaires de Genève	Geneve
United Kingdom	Nhs Fundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Bordeaux Colorectal Institute Academy

Countries where clinical trial is conducted

Argentina,  Belgium,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluate the Length of hospital stay after colorectal surgery.	From the surgery to the end of the hospitalization (max 30 days)
Secondary	The impact of stable low pressure on the postoperative pain after colorectal surgery	Pain is evaluated (Visual Analgesic Scale (Vas scores from 0 (no pain) to 10 (hurst worst))	At 24 hours after the end of the surgery
Secondary	The impact of stable low pressure on the opioid consumption after colorectal surgery	Evaluate the impact on the opioid consumption after colorectal surgery;	From the surgery to the end of the hospitalization (max 30 days)
Secondary	The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure	Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery	From the surgery to the end of the hospitalization (max 30 days)
Secondary	The Post-operative Surgical and Medical morbidity	Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification	From the surgery to the end of the hospitalization (max 30 days)
Secondary	The impact of the anesthetic management on the feasibility and benefit of low stable pressure	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	From the surgery to the end of the hospitalization (max 30 days)
Secondary	The Surgical and Medical morbidity at 30 days	Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification	At 30 days after the end of the surgery