At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 21 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called the CROSS study, looks at surgery on the colon or rectum using a method that keeps the pressure inside the abdomen low and steady during the operation. This is done with a system called AirSeal during keyhole (laparoscopic) or robotic surgery. It is for adults having part or all of their colon or rectum removed because of benign (non-cancer) or malignant (cancer) tumours.
Who can take part
- Adults aged 18 or over
- Having part or all of the colon removed (right, left, subtotal or total) for a benign or malignant condition
- Having rectal surgery, with or without a stoma, for a benign or malignant condition
- Surgery done by keyhole (laparoscopic) or robotic method
- Surgery carried out using low stable pressure with the AirSeal system
- Covered by the medicare system
- Agreeing to take part after reading the information letter
Who may not be able to
- Open surgery through a larger cut (laparotomy)
- Having other organs removed at the same time (except the appendix or a liver biopsy)
- Surgery on the transverse colon (the middle part of the colon)
- Emergency surgery
- Infection in the pelvis (pelvic sepsis)
- Pregnancy or breastfeeding
- Being unable to agree to take part for legal, physical, psychological, social or geographical reasons
- People deprived of liberty or under guardianship
What taking part involves
- • Surgery on the colon or rectum using keyhole (laparoscopic) or robotic methods
- • Low stable pressure inside the abdomen during surgery, using the AirSeal system
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2023-12-15
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for colorectal surgery
- • Clinical study - 300 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with colorectal surgery
Where?
- • Manchester - Nhs Fundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Laparotomy procedure
- ✗Associated resection (except appendectomy or liver biopsy)
- ✗Transverse colectomy
- ✗Emergency procedure
- ✗Pelvic sepsis
See the full criteria
Where Is This Study? (1 UK site)
Nhs Fundation Trust
Manchester M139WL, United Kingdom
How to Get in Touch
Quentin QD DENOST, Prof
Sponsor contactCONTACT
Hélène HMM MAILLOU-MARTINAUD
Sponsor contactCONTACT