NCT06154785

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 program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
8 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

November 24, 2023

Last Update Submit

July 31, 2025

Conditions

Colorectal SurgeryBenign or Malignant Rectal or Colon Tumors

Keywords

colorectal pathologylow stable pressurelaparoscopiclength hospital stay

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The impact of stable low pressure on the postoperative pain after colorectal surgery

    At 24 hours after the end of the surgery

  • The impact of stable low pressure 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

    From the surgery to the end of the hospitalization (max 30 days)

  • The Post-operative Surgical and Medical morbidity

    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

    From the surgery to the end of the hospitalization (max 30 days)

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Universitair Ziekenhuis

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Hôpital Jean Minoz

Besançon, 25030, France

NOT YET RECRUITING

Clinique Tivoli-Ducos - Bordeaux Colorectal Institute

Bordeaux, 33 000, France

RECRUITING

Hôpital Albert Michallon

La Tronche, 38700, France

NOT YET RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

NOT YET RECRUITING

Hôpital Nord-Marseille

Marseille, 13915, France

RECRUITING

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

NOT YET RECRUITING

Hopital Saint-Louis

Paris, 75010, France

NOT YET RECRUITING

Hôpital Saint-Antoine

Paris, 75012, France

NOT YET RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75908, France

NOT YET RECRUITING

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

Hopital Charles Nicolle

Rouen, 76031, France

RECRUITING

St. Georg Klinikum Eisenach

Eisenach, 99817, Germany

NOT YET RECRUITING

Division of Colon and Rectal Surgery

Milan, 20089, Italy

RECRUITING

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Hospital General Universitario Gregorio

Madrid, 28007, Spain

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

Nhs Fundation Trust

Manchester, M139WL, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Quentin QD DENOST, Prof

CONTACT

+33(0)5 47 50 15 75q.denost@bordeaux-colorectal-institute.fr

Hélène HMM MAILLOU-MARTINAUD

CONTACT

+ 33 (0)6 68 68 68 05h.maillou.martinaud@bordeaux-colorectal-institute.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 4, 2023

Study Start

December 15, 2023

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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

Locations

NL(1)DE(1)IT(1)FR(11)CH(1)BE(1)GB(1)ES(1)