Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY) (CROSS)

July 31, 2025 updated by: Bordeaux Colorectal Institute Academy

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Bruxelles
      • Jette, Bruxelles, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis
        • Principal Investigator:
          • Ellen EVE VAN EETVELDE
        • Contact:
  • France
      • Besançon, France, 25030
        • Not yet recruiting
        • Hopital Jean Minoz
        • Contact:
        • Principal Investigator:
          • Zaher ZL Lakkis
      • Bordeaux, France, 33 000
        • Recruiting
        • Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
        • Contact:
        • Principal Investigator:
          • Quentin QD DENOST
      • La Tronche, France, 38700
        • Not yet recruiting
        • Hôpital Albert Michallon
        • Contact:
        • Principal Investigator:
          • Bertrand BT TRILLING
      • Le Kremlin-Bicêtre, France, 94270
        • Not yet recruiting
        • Hôpital Bicêtre
        • Contact:
        • Principal Investigator:
          • Antoine AB BROUQUET
      • Marseille, France, 13915
        • Recruiting
        • Hôpital Nord-Marseille
        • Contact:
        • Principal Investigator:
          • Laura LBB BEYER-BERJOT
      • Neuilly-sur-Seine, France, 92200
        • Not yet recruiting
        • Clinique Hartmann
        • Contact:
        • Principal Investigator:
          • Yves YP PANIS
      • Paris, France, 75010
        • Not yet recruiting
        • Hopital Saint-Louis
        • Contact:
        • Principal Investigator:
          • Léon LM MAGGIORI
      • Paris, France, 75012
        • Not yet recruiting
        • Hopital Saint-Antoine
        • Contact:
        • Principal Investigator:
          • Jérémie JL LEFEVRE
      • Paris, France, 75908
        • Not yet recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
        • Principal Investigator:
          • Gilles GM MANCEAU
      • Pierre benite, France, 69495
        • Recruiting
        • Hôpital Lyon Sud
        • Contact:
        • Principal Investigator:
          • Eddy EC COTTE
      • Rouen, France, 76031
        • Recruiting
        • Hopital Charles Nicolle
        • Contact:
        • Principal Investigator:
          • Jean-Jacques JJT TUECH
  • Germany
      • Eisenach, Germany, 99817
        • Not yet recruiting
        • St. Georg Klinikum Eisenach
        • Contact:
        • Principal Investigator:
          • Markus MM MILLE
  • Italy
      • Milan, Italy, 20089
        • Recruiting
        • Division of Colon and Rectal Surgery
        • Contact:
        • Principal Investigator:
          • Antonino AS SPINELLI
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Academic Medical Center
        • Contact:
        • Principal Investigator:
          • Roel RH HOMPES
  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio
        • Contact:
        • Principal Investigator:
          • Patricia PT TEJEDOR
  • Switzerland
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève
        • Contact:
        • Principal Investigator:
          • Frederic FR RIS
  • United Kingdom
      • Manchester, United Kingdom, M139WL
        • Not yet recruiting
        • Nhs Fundation Trust
        • Contact:
        • Principal Investigator:
          • Deena DH HARJI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
International cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From the surgery to the end of the hospitalization (max 30 days)
Evaluate the Length of hospital stay after colorectal surgery.
From the surgery to the end of the hospitalization (max 30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of stable low pressure on the postoperative pain after colorectal surgery
Time Frame: At 24 hours after the end of the 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
The impact of stable low pressure on the opioid consumption after colorectal surgery
Time Frame: From the surgery to the end of the hospitalization (max 30 days)
Evaluate the impact on the opioid consumption after colorectal surgery;
From the surgery to the end of the hospitalization (max 30 days)
The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure
Time Frame: From the surgery to the end of the hospitalization (max 30 days)
Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery
From the surgery to the end of the hospitalization (max 30 days)
The Post-operative Surgical and Medical morbidity
Time Frame: From the surgery to the end of the hospitalization (max 30 days)
Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification
From the surgery to the end of the hospitalization (max 30 days)
The impact of the anesthetic management on the feasibility and benefit of low stable pressure
Time Frame: From the surgery to the end of the hospitalization (max 30 days)
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)
The Surgical and Medical morbidity at 30 days
Time Frame: At 30 days after the end of the surgery
Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification
At 30 days after the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bordeaux Colorectal Institute Academy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.C.I.A 2023/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share individual participant data (IPD) with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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