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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Page 1 of 5 (18 locations)

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