Status:
RECRUITING
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
Lead Sponsor:
Bordeaux Colorectal Institute Academy
Conditions:
Colorectal Surgery
Benign or Malignant Rectal or Colon Tumors
Eligibility:
All Genders
18+ years
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 progr...
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 lap...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Colonic resection (right or left, subtotal or total) performed for benign or malignant pathology
- Rectal resection 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
- 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
Key Trial Info
Start Date :
December 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06154785
Start Date
December 15 2023
End Date
September 1 2025
Last Update
August 1 2025
Active Locations (18)
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1
Universitair Ziekenhuis
Jette, Brussels Capital, Belgium, 1090
2
Hôpital Jean Minoz
Besançon, France, 25030
3
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
Bordeaux, France, 33 000
4
Hôpital Albert Michallon
La Tronche, France, 38700