Benign or Malignant Rectal or Colon Tumors, Colorectal Surgery
Conditions
Keywords
colorectal pathology, low stable pressure, laparoscopic, length hospital stay
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.
Interventions
None listed
Sponsors
Bordeaux Colorectal Institute Academy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From the surgery to the end of the hospitalization (max 30 days) | Evaluate the Length of hospital stay after colorectal surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The impact of stable low pressure on the opioid consumption after colorectal surgery | From the surgery to the end of the hospitalization (max 30 days) | Evaluate the impact on the opioid consumption after colorectal surgery; |
| The impact of the different mini-invasive approaches on the feasibility and benefit of low stable pressure | From the surgery to the end of the hospitalization (max 30 days) | Evaluate the impact of robotic, laparoscopic +/- microsurgical instrument, 3D laparoscopic vision surgery |
| The impact of stable low pressure on the postoperative pain after colorectal surgery | At 24 hours after the end of the surgery | Pain is evaluated (Visual Analgesic Scale (Vas scores from 0 (no pain) to 10 (hurst worst)) |
| The impact of the anesthetic management on the feasibility and benefit of low stable pressure | From the surgery to the end of the hospitalization (max 30 days) | 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 |
| The Surgical and Medical morbidity at 30 days | At 30 days after the end of the surgery | Surgical and Medical morbidity at 30 days according to the Clavien-Dindo Classification |
| The Post-operative Surgical and Medical morbidity | From the surgery to the end of the hospitalization (max 30 days) | Post operative Surgical and Medical morbidity according to the Clavien-Dindo Classification |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Contacts
Primary ContactQuentin QD DENOST, Prof
Backup ContactHélène HMM MAILLOU-MARTINAUD
Outcome results
None listed