Clinical Trials in Germany / NCT06154785
Recruiting
Observational
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
NCT06154785 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Colorectal SurgeryBenign or Malignant Rectal or Colon Tumors
Study 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.
Eligibility
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
Primary outcome measure(s)
- 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. — From the surgery to the end of the hospitalization (max 30 days)
Evaluate the Length of hospital stay after colorectal surgery.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Universitair Ziekenhuis | Jette | Brussels Capital | Recruiting |
| Hôpital Jean Minoz | Besançon | France | Not Yet Recruiting |
| Clinique Tivoli-Ducos - Bordeaux Colorectal Institute | Bordeaux | France | Recruiting |
| Hôpital Albert Michallon | La Tronche | France | Not Yet Recruiting |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Not Yet Recruiting |
| Hôpital Nord-Marseille | Marseille | France | Recruiting |
| Clinique Hartmann | Neuilly-sur-Seine | France | Not Yet Recruiting |
| Hopital Saint-Louis | Paris | France | Not Yet Recruiting |
| Hôpital Saint-Antoine | Paris | France | Not Yet Recruiting |
| Hôpital Européen Georges Pompidou | Paris | France | Not Yet Recruiting |
| Hôpital Lyon Sud | Pierre-Bénite | France | Recruiting |
| Hopital Charles Nicolle | Rouen | France | Recruiting |
| St. Georg Klinikum Eisenach | Eisenach | Germany | Not Yet Recruiting |
| Division of Colon and Rectal Surgery | Milan | Italy | Recruiting |
| Academic Medical Center | Amsterdam | Netherlands | Recruiting |
| Hospital General Universitario Gregorio | Madrid | Spain | Recruiting |
| Hôpitaux Universitaires de Genève | Geneva | Switzerland | Recruiting |
| Nhs Fundation Trust | Manchester | United Kingdom | Not Yet Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06154785 on ClinicalTrials.gov ↗ ← All trials in Germany