Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

Study Overview
=================
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.

Detailed Description
-----------------
Laparoscopy is currently the gold standard for the vast majority of abdominal surgeries, and especially for colectomy for cancer or benign diseases. There are many data showing the benefits of the laparoscopic approach to colectomy in terms of morbidity, post-operative pain and analgesic consumption, length of hospital stay, cosmetic results, and improved patient satisfaction. In 2002, consensus European guidelines recommended insufflating at the lowest pressure that still provides sufficient exposure. Considering these results, low-pressure laparoscopy is one of the alternatives that have been developed to do away with the complications of the pneumoperitoneum while retaining its advantages. However, other factors may influence the outcomes of the low-pressure pneumoperitoneum such as the use of humidification and warming gaz, robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall, ventilation-induced changes, and probably individual patient factors like obesity. These parameters could not be separately tested in randomized trial. We should consider all these parameters in a prospective international registry in order to optimize the benefit of low-pressure pneumoperitoneum in post-operative recovery.

Official Title
-----------------
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)

Conditions
-----------------
Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Colonic resection (right or left) performed for benign or malignant pathology Partial or Total mesorectal Excision (PME or TME) 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
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| International cohort<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the surgery to the end of the hospitalization (max 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | At 24 hours after the end of the surgery | 
| The impact of stable low pressure on the opioid consumption after colorectal surgery | Evaluate the impact on the opioid consumption after colorectal surgery; | From the surgery to the end of the hospitalization (max 30 days) | 
| 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 | From the surgery to the end of the hospitalization (max 30 days) | 
| The Post-operative Surgical and Medical morbidity | Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification | From the surgery to the end of the hospitalization (max 30 days) | 
| The impact of the anesthetic management on the feasibility and benefit of low stable pressure | Evaluate the impact of drugs, deep neuromuscular blockade, ventilation characteristics, intraoperative nociception monitoring, patient positioning, pre-stretching of the abdominal wall, and individual patient factors | From the surgery to the end of the hospitalization (max 30 days) | 
| The Surgical and Medical morbidity at 30 days | Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification | At 30 days after the end of the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal pathology, low stable pressure, laparoscopic, length hospital stay