NCT06154785 Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
| NCT ID | NCT06154785 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bordeaux Colorectal Institute Academy |
| Condition | Colorectal Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-12-15 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06154785 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06154785 currently recruiting?
Yes, NCT06154785 is actively recruiting participants. Contact the research team at q.denost@bordeaux-colorectal-institute.fr for enrollment information.
Where is the NCT06154785 trial being conducted?
This trial is being conducted at Jette, Belgium, Besançon, France, Bordeaux, France, La Tronche, France and 11 additional locations.
Who is sponsoring the NCT06154785 clinical trial?
NCT06154785 is sponsored by Bordeaux Colorectal Institute Academy. The trial plans to enroll 300 participants.