Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France, Germany, Italy, Netherlands +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
Overview
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.
Primary outcome measures
- 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. [Time frame: From the surgery to the end of the hospitalization (max 30 days)]
Secondary outcome measures (6)
- The impact of stable low pressure on the postoperative pain after colorectal surgery [Time frame: At 24 hours after the end of the surgery]
- The impact of stable low pressure on the opioid consumption after colorectal surgery [Time frame: 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 [Time frame: From the surgery to the end of the hospitalization (max 30 days)]
- The Post-operative Surgical and Medical morbidity [Time frame: 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 [Time frame: From the surgery to the end of the hospitalization (max 30 days)]
- The Surgical and Medical morbidity at 30 days [Time frame: At 30 days after the end of the surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 11 centers
- Hôpital Jean Minoz — Besançon
- Clinique Tivoli-Ducos - Bordeaux Colorectal Institute — Bordeaux
- Hôpital Albert Michallon — La Tronche
- Hôpital Bicêtre — Le Kremlin-Bicêtre
- Hôpital Nord-Marseille — Marseille
- Clinique Hartmann — Neuilly-sur-Seine
- Hopital Saint-Louis — Paris
- Hôpital Saint-Antoine — Paris
- … and 3 more centers
Belgium · 1 center
- Universitair Ziekenhuis — Jette
Germany · 1 center
- St. Georg Klinikum Eisenach — Eisenach
Italy · 1 center
- Division of Colon and Rectal Surgery — Milan
Netherlands · 1 center
- Academic Medical Center — Amsterdam
Spain · 1 center
- Hospital General Universitario Gregorio — Madrid
Switzerland · 1 center
- Hôpitaux Universitaires de Genève — Geneva
United Kingdom · 1 center
- Nhs Fundation Trust — Manchester
Identifiers
NCT: NCT06154785 · B.C.I.A 2023/01