Using low stable pressure in colorectal surgery to improve recovery
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
This study is testing if using low stable pressure during colorectal surgery can help patients recover faster and feel better afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bordeaux Colorectal Institute Academy Academic / other |
| Locations | 18 sites (Jette, Brussels Capital and 17 other locations) |
| Trial ID | NCT06154785 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of low stable pressure pneumoperitoneum during colorectal surgeries on postoperative recovery. By utilizing the Airseal Insufflator, the study will assess various parameters that may influence recovery, including pain management, length of hospital stay, and overall patient satisfaction. The research will involve a prospective international cohort to gather data on the effectiveness of this approach in enhancing early rehabilitation programs after surgery. The findings could help optimize surgical techniques and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older undergoing laparoscopic or robotic colonic resection for benign or malignant conditions.
Not a fit: Patients undergoing laparotomy procedures or those with conditions such as pelvic sepsis or pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter hospital stays and reduced postoperative pain for patients undergoing colorectal surgery.
How similar studies have performed: Previous studies have shown promising results with low-pressure laparoscopic techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jette, Brussels Capital and 17 other locations
- Universitair Ziekenhuis — Jette, Brussels Capital, Belgium (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)
Study contacts
- Study coordinator: Quentin QD DENOST, Prof
- Email: q.denost@bordeaux-colorectal-institute.fr
- Phone: +33(0)5 47 50 15 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.