Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

Bordeaux Colorectal Institute Academy

Status

Enrolling

Conditions

Benign or Malignant Rectal or Colon Tumors

Colorectal Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06154785

B.C.I.A 2023/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

International cohort

Description:

This is an international cohort (France and other international centers) which consists of including patients undergoing colorectal surgery performed at low pressure for benign or malignant pathology.This stage 2b 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.