Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBordeaux Colorectal Institute Academy
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Laparotomy procedure
Associated resection (except appendectomy or liver biopsy)
Transverse colectomy
Emergency procedure
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: International cohort
Trial outcomes
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.
Time frame
From the surgery to the end of the hospitalization (max 30 days)Secondary outcomes
1
The impact of stable low pressure on the postoperative pain after colorectal surgery
Pain is evaluated (Visual Analgesic Scale (Vas scores from 0 (no pain) to 10 (hurst worst))
Time frame
At 24 hours after the end of the surgery2
The impact of stable low pressure on the opioid consumption after colorectal surgery
Evaluate the impact on the opioid consumption after colorectal surgery;
Time frame
From the surgery to the end of the hospitalization (max 30 days)3
The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure
Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery
Time frame
From the surgery to the end of the hospitalization (max 30 days)4
The Post-operative Surgical and Medical morbidity
Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification
Time frame
From the surgery to the end of the hospitalization (max 30 days)Sponsors and contacts
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Source ClinicalTrials.gov