Clinical trial · Observational
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
NCT06154785CI-TRIAL-00092979CROSSrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign or Malignant Rectal or Colon Tumors | Colon Neoplasm | PROBABILISTIC | 0.70 |
| Colorectal Surgery | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- International cohort
- description
- 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.
Primary outcomes (1)
- measure
- 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.
- timeFrame
- From the surgery to the end of the hospitalization (max 30 days)
- description
- Evaluate the Length of hospital stay after colorectal surgery.
Secondary outcomes (6)
- measure
- The impact of stable low pressure on the postoperative pain after colorectal surgery
- timeFrame
- At 24 hours after the end of the surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.