Colorectal SurgeryCROSSNCT06154785
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
An observational study of Colorectal Surgery and Benign or Malignant Rectal or Colon Tumors, run by Bordeaux Colorectal Institute Academy at 18 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors
- How many people
- 300 participants
- Where
- 18 sitesin 8 countries
- Study dates
- 15 Dec 2023to Sep 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Hélène HMM MAILLOU-MARTINAUD contact
18 sites in 8 countries
France11 sites, 11 recruiting
- Not yet recruiting
Hôpital Jean Minoz
Besançon, 25030
Zaher ZL LAKKIS, +33(0)3 81 66 81 66, zlakkis@chu-besancon.fr
Zaher ZL Lakkis
- Recruiting
Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
Bordeaux, 33 000
Quentin QD DENOST, Prof, +33 (0)5 47 50 15 75, q.denost@bordeaux-colorectal-institute.fr
Quentin QD DENOST
- Not yet recruiting
Hôpital Albert Michallon
La Tronche, 38700
Bertrand BT TRILLING, +33(0)4 76 76 55 26, BTrilling@chu-grenoble.fr
Bertrand BT TRILLING
- Not yet recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Antoine AB BROUQUET, +33 (0)1 45 21 70 30, antoine.brouquet@aphp.fr
Antoine AB BROUQUET
- Recruiting
Hôpital Nord-Marseille
Marseille, 13915
Laura LBB BEYER-BERJOT, +33(0)491964940, laura.beyer@ap-hm.fr
Laura LBB BEYER-BERJOT
- Not yet recruiting
Clinique Hartmann
Neuilly-sur-Seine, 92200
Panis YP Yves, +33 (0)1 46 39 89 89, yves.panis@gmail.com
Yves YP PANIS
- Not yet recruiting
Hopital Saint-Louis
Paris, 75010
Léon LM MAGGIORI, +3350°1 42 49 49 49, leon.maggiori@aphp.fr
Léon LM MAGGIORI
- Not yet recruiting
Hôpital Saint-Antoine
Paris, 75012
Jérémie JL Lefevre, +33 (0)1 49 28 26 87, jeremie.lefevre@aphp.fr
Jérémie JL LEFEVRE
- Not yet recruiting
Hôpital Européen Georges Pompidou
Paris, 75908
Gilles GM MANCEAU, +33(0)1 56 09 35 34, gilles.manceau@aphp.fr
Gilles GM MANCEAU
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69495
Eddy EC COTTE, +33(0)4 78 86 13 85, eddy.cotte@chu-lyon.fr
Eddy EC COTTE
- Recruiting
Hopital Charles Nicolle
Rouen, 76031
Jean-Jacques JJT TUECH, +33(0)2 32 88 81 42, jean-jacques.tuech@chu-rouen.fr
Jean-Jacques JJT TUECH
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis
Jette, Brussels Capital, 1090
Ellen EV VAN EETVELDE, +39 08 82 24 47 72, ellen.VanEetvelde@uzbrussel.be
Ellen EVE VAN EETVELDE
Germany1 site, 1 recruiting
- Not yet recruiting
St. Georg Klinikum Eisenach
Eisenach, 99817
Markus MM MILLE, +49 3691 6980, mille.markus@stgeorgklinikum.de
Markus MM MILLE
Italy1 site, 1 recruiting
- Recruiting
Division of Colon and Rectal Surgery
Milan, 20089
Antonino AS SPINELLI, +39 02 82 24 47 72, antonino.spinelli@hunimed.eu
Antonino AS SPINELLI
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, 1105 AZ
Roel RH HOMPES, +31 20 566 9111, r.hompes@amc.uva.nl
Roel RH HOMPES
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio
Madrid, 28007
Patricia PT TEJEDOR, +34 9115 86 80 00, patricia.tejedor@hotmail.com
Patricia PT TEJEDOR
Switzerland1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Genève
Geneva, 1205
Frederic FR RIS, +41 22 372 7704, frederic.ris@hcuge.ch
Frederic FR RIS
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Nhs Fundation Trust
Manchester, M139WL
Deena DH HARJI, +44 161 276 1234, deena.harji@hotmail.com
Deena DH HARJI
About this study
Official title: Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
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.
Read the 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.
- Keywords
- colorectal pathology, low stable pressure, laparoscopic, length hospital stay
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| International cohort | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the surgery to the end of the hospitalization (max 30 days)
Secondary outcomes (6)
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))
Measured: 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;
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 30 days after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start15 Dec 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Bordeaux Colorectal Institute Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154785
- Sponsor's protocol ID
- B.C.I.A 2023/01
- Acronym
- CROSS
- Status last verified
- Jul 2025
- First submitted
- 24 Nov 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD) with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)
- ClinicalTrials.gov ID
- NCT06154785
- Acronym / sponsor ID
- CROSS / B.C.I.A 2023/01
- Keywords
- colorectal pathology, low stable pressure, laparoscopic, length hospital stay
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bordeaux Colorectal Institute AcademyUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| International cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Laparotomy procedure
- Associated resection (except appendectomy or liver biopsy)
- Transverse colectomy
- Emergency procedure
- Pelvic sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Evaluate the Length of hospital stay after colorectal surgery.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD) with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hélène HMM MAILLOU-MARTINAUD contact
18 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery and Benign or Malignant Rectal or Colon Tumors, run by Bordeaux Colorectal Institute Academy at 18 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Belgium, Germany, Italy, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quentin QD DENOST, Prof (+33(0)5 47 50 15 75, q.denost@bordeaux-colorectal-institute.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.