Colorectal SurgeryPAROS3NCT05934981
Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation
A study testing Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation and Laparoscopic surgery under low pressure and conventional Insufflation in people with Colorectal Surgery and Benign or Malignant Rectal or Colon Tumors, run by Bordeaux Colorectal Institute Academy at 2 sites in France.
Trial summary
To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F \& 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation. 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
- What is being tested?
- Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation and Laparoscopic surgery under low pressure and conventional Insufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Aug 2023to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal surgery for malignant or benign pathology
- Surgery without stoma
- Patient operable by laparoscopy or robot assisted under low pressure pneumoperitoneum
- Age ≥ 18 years old
- Patient affiliated to a social security system or beneficiary of the same
- Informing the patient and obtaining free, informed, and written consent, signed by the patient and his investigator.
Who cannot join
- Laparotomy procedure
- Total or Subtotal Colectomy
- Transverse segmental colectomy
- Proctectomy with stoma or Total Coloproctectomy
- Procedure associated with colorectal surgery (except appendectomy or liver biopsy)
- Patient with stoma
Show all 21Show fewer
- Probable realization of a stoma during the operation
- Crohn's disease, Hemorrhagic Rectocolitis (UC) with VAS > 3
- Diverticulitis or Sigmoiditis with VAS > 3
- Endometriosis with VAS >3
- VAS before surgery> 3
- BMI ≥ 30
- ASA ≥ 3 (except if ASA 3 for non-cardiac and/or vascular diseases)
- History of laparotomy
- Emergency surgery
- Pelvic Sepsis or Preoperative Fistula
- Pregnant woman, likely to be, or breastfeeding
- Persons deprived of their liberty or under measure of judicial protection (curators or guardianship) or unable to give their consent
- Persons undergoing psychiatric treatment without their consent
- Persons admitted to a health or social establishment for purposes other than research
- Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique TIVOLI DUCOS - Bordeaux Colorectal Institute
Bordeaux
HOPITAL NORD APHM - Service de Chirurgie Digestive
Marseille
About this study
Official title: Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone
To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F \& 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation.
A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.
Read the detailed description
Laparoscopy is the gold standard in colorectal surgery with many benefits in term of morbidity, post-operative pain and analgesic consumption. However, the pneumoperitoneum created for the laparoscopy has several negatives impact and limits (specific pain following abdominal distension, visibility, physiological repercussion).
To improve recovery after colorectal laparoscopic surgery it was realized a first study (PAROS 1) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay (3 vs. 4 days; p=0.001), and decrease post-operative pain (VAS ≤ 3 à H8: 87% vs. 72% ; p=0.039) with reduction of analgesic consumption (step II analgesics: 73% vs. 88% ; p=0.032 and step 3 analgesics: (10% vs.23% ; p=0.042) (Br J Surg. 2021 Aug 19;108(8):998-1005) Simultaneously, the development of humidification medical device, referring to the administration of heated and humidified CO2 during laparoscopic surgery, aims to reduce the effects of cell drying and evaporative heat loss when the body is exposed to cold CO2. and dry during laparoscopic surgery. The state of the CO2 traditionally used during laparoscopic surgery and the ambient air during open surgery is very different from that of the human body, as it directly extracts heat and humidity from the already fragile patient.
The introduction of heated and humidified CO2 provides an environment that reflects the physiological state of the peritoneum.
Added to the benefits of low pressure, the advantages of surgical humidification seem very positive. During surgery, surgical humidification would reduce the incidence of perioperative hypothermia, improve local tissue oxygenation and local tissue perfusion. After surgery, it would improve core body temperature, reduce local peritoneal inflammation, surgical site infection rate and recovery time. The benefits of a warmed and humidified CO2 also seem very positive in terms of reducing postoperative pain and analgesic consumption. In the long term, it would reduce adhesion formation, tumor burden, metastases, and economic cost.
The aim of the study is to assess the impact of low-pressure pneumoperitoneum with warm and humidified CO2 insufflation on post-operative pain without taking opioids, compared with low-pressure laparoscopy with cold and dry gas insufflation.
- Being tested
- Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation, Laparoscopic surgery under low pressure and conventional Insufflation
- Keywords
- colorectal pathology, laparoscopic, low pressure, early postoperative rehabilitation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgery under low pressure and warm and humidified CO2 InsufflationProcedure or surgery
low pressure pneumoperitoneum (5-8mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation.
Laparoscopic surgery under low pressure and conventional InsufflationProcedure or surgery
low pressure pneumoperitoneum (5-8mmHg), and use standard room temperature with dry insufflation.
| Study group | Role | What they receive |
|---|---|---|
| Low Pressure and warm and humidified CO2 insufflation | Experimental | Low pressure pneumoperitoneum and use warm and humidified CO2 insufflation Receives: Procedure: Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation |
| Low Pressure | Active comparator | Low pressure pneumoperitoneum Receives: Procedure: Laparoscopic surgery under low pressure and conventional Insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with pain at 24 hours after the end of the intervention by VAS ≤ 3 without taking opioids (without step 2 and step 3 analgesics).
Pain is evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)
Measured: At 24 hours after the end of surgery
Secondary outcomes (15)
Operating time
Operating time
Measured: During surgery
Conversion rate in normal pressure and laparotomy
Conversion rate in normal pressure (12-15mmHg) and laparotomy
Measured: During surgery
Peri-operative Heart Rate
Evaluation of Heart rate at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation".
Measured: During surgery
Perioperative arterial blood pressure
Evaluation of arterial pressure at different times during surgery : "after anesthetic intubation", "15 min after insufflation", and "5 min after exsufflation"
Measured: During surgery
Peri-operative temperature variations
Evaluation of ambient theatre temperature and body temperature at different times during surgery : "before incision", "15 min after insufflation",then every hour and the last temperature reading at the end of the surgery.
Measured: During surgery
Rate of c-reactive protein
c-reactive protein levels in serum over 4 days post-surgery
Measured: from day 1 to day 4 after the end of surgery
Time to bowel opening and passage of gas
Time to bowel opening and passage of gas
Measured: An average of 3 days after the surgery
Number of patients with medical and/or surgical morbidity
To analyse the cumulative morbidity at 30 days after surgery and at 3 months of follow-up according to the Clavien-DINDO classification
Measured: From the end of surgery until 3 months of follow-up
Number of patients with R0 resection
Rate of cumulative surgery R0 resection for oncologic surgery
Measured: During Surgery
Length of stay in hospital
Length of stay in hospital
Measured: From the surgery to the end of the hospitalization (max30 days)
Number of patients with pain at 30 days
Pain was evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)) during hospital stay and until 30 days using a patient subject diary every day and immediately before each use of pain medication
Measured: From the end of the surgery until 30 days of follow-up
Number of patients taking analgesics until 30 days
To analyse the rate of analgesics using a patient subject diary
Measured: From the end of the surgery until 30 days of follow up
Mean Score of the EQ-5D-5L Quality of Life
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The questionnaire is a self-report survey that measures quality of life across 5 domains: : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
- The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, numbered from 0 to 100. ( 100 means "the best health you can imagine" and 0 means "the worst health you can imagine".)
Measured: From randomization until 3 months after surgery
Evaluation of predictive factors of postoperative pain
Study the predictive factors of postoperative pain (VAS>3), 24 hours and 30 days after the surgery. (Visual Analogue Scale (VAS), from 0 (no pain) to 10 (hurts worst)).
Measured: From the surgery until 30 days of follow up
Evaluation of predictive factors of opioid intake
To identify predictive factors of opioid intake (second step and/or third step of the Who analgesic ladder),24 hours and 30 days after the surgery.
Comparison of the clinical and perioperative data from patients who did or did not consume opioids after surgery. The differences in proportions will be compared.
Measured: From the surgery until 30 days of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 Aug 2023
- Primary completion20 Apr 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bordeaux Colorectal Institute Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quentin DENOST, Study director, Bordeaux Colorectal Institute Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934981
- Sponsor's protocol ID
- BCIA 2022/01
- Acronym
- PAROS3
- Status last verified
- Jun 2026
- First submitted
- 30 May 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He J, Pan X. Carbon dioxide laparoscopic technology: research hotspots and innovations in pneumoperitoneum detection. Med Gas Res. 2026 Dec 1;16(4):415-425. doi: 10.4103/mgr.MEDGASRES-D-25-00206. Epub 2026 Mar 26.
PubMed 41888042
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Low Pressure in Laparoscopic Colorectal Resection With Warm and Humidified Carbon Dioxide Pneumoperitoneum Versus Low Pressure Pneumoperitoneum Alone
- ClinicalTrials.gov ID
- NCT05934981
- Acronym / sponsor ID
- PAROS3 / BCIA 2022/01
- Keywords
- colorectal pathology, laparoscopic, low pressure, early postoperative rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Bordeaux Colorectal Institute AcademyUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 7 Jul 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.
To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F \& 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation.
A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.
Detailed description
Laparoscopy is the gold standard in colorectal surgery with many benefits in term of morbidity, post-operative pain and analgesic consumption. However, the pneumoperitoneum created for the laparoscopy has several negatives impact and limits (specific pain following abdominal distension, visibility, physiological repercussion).
To improve recovery after colorectal laparoscopic surgery it was realized a first study (PAROS 1) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay (3 vs. 4 days; p=0.001), and decrease post-operative pain (VAS ≤ 3 à H8: 87% vs. 72% ; p=0.039) with reduction of analgesic consumption (step II analgesics: 73% vs. 88% ; p=0.032 and step 3 analgesics: (10% vs.23% ; p=0.042) (Br J Surg. 2021 Aug 19;108(8):998-1005) Simultaneously, the development of humidification medical device, referring to the administration of heated and humidified CO2 during laparoscopic surgery, aims to reduce the effects of cell drying and evaporative heat loss when the body is exposed to cold CO2. and dry during laparoscopic surgery. The state of the CO2 traditionally used during laparoscopic surgery and the ambient air during open surgery is very different from that of the human body, as it directly extracts heat and humidity from the already fragile patient.
The introduction of heated and humidified CO2 provides an environment that reflects the physiological state of the peritoneum.
Added to the benefits of low pressure, the advantages of surgical humidification seem very positive. During surgery, surgical humidification would reduce the incidence of perioperative hypothermia, improve local tissue oxygenation and local tissue perfusion. After surgery, it would improve core body temperature, reduce local peritoneal inflammation, surgical site infection rate and recovery time. The benefits of a warmed and humidified CO2 also seem very positive in terms of reducing postoperative pain and analgesic consumption. In the long term, it would reduce adhesion formation, tumor burden, metastases, and economic cost.
The aim of the study is to assess the impact of low-pressure pneumoperitoneum with warm and humidified CO2 insufflation on post-operative pain without taking opioids, compared with low-pressure laparoscopy with cold and dry gas insufflation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pressure and warm and humidified CO2 insufflation | Experimental | Procedure: Laparoscopic surgery under low pressure and warm and humidified CO2 InsufflationLow pressure pneumoperitoneum and use warm and humidified CO2 insufflation |
| Low Pressure | Active comparator | Procedure: Laparoscopic surgery under low pressure and conventional InsufflationLow pressure pneumoperitoneum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Colorectal surgery for malignant or benign pathology
- Surgery without stoma
- Patient operable by laparoscopy or robot assisted under low pressure pneumoperitoneum
- Age ≥ 18 years old
- Patient affiliated to a social security system or beneficiary of the same
Key exclusion criteria (21 listed)
- Laparotomy procedure
- Total or Subtotal Colectomy
- Transverse segmental colectomy
- Proctectomy with stoma or Total Coloproctectomy
- Procedure associated with colorectal surgery (except appendectomy or liver biopsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflationlow pressure pneumoperitoneum (5-8mmHg) and use warm (35°C), humidified (95% relative humidity) CO2 insufflation. | Procedure or surgery | Low Pressure and warm and humidified CO2 insufflation |
| Laparoscopic surgery under low pressure and conventional Insufflationlow pressure pneumoperitoneum (5-8mmHg), and use standard room temperature with dry insufflation. | Procedure or surgery | Low Pressure |
Primary outcome
Number of patients with pain at 24 hours after the end of the intervention by VAS ≤ 3 without taking opioids (without step 2 and step 3 analgesics).
Time frame: At 24 hours after the end of surgery
Pain is evaluated with the Visual Analogue Scale (VAS, from 0 (no pain) to 10 (hurts worst)
15 secondary outcomes
Operating time
Time frame: During surgery
Conversion rate in normal pressure and laparotomy
Time frame: During surgery
Peri-operative Heart Rate
Time frame: During surgery
Perioperative arterial blood pressure
Time frame: During surgery
Peri-operative temperature variations
Time frame: During surgery
Rate of c-reactive protein
Time frame: from day 1 to day 4 after the end of surgery
Time to bowel opening and passage of gas
Time frame: An average of 3 days after the surgery
Number of patients with medical and/or surgical morbidity
Time frame: From the end of surgery until 3 months of follow-up
Number of patients with R0 resection
Time frame: During Surgery
Length of stay in hospital
Time frame: From the surgery to the end of the hospitalization (max30 days)
Number of patients with pain at 30 days
Time frame: From the end of the surgery until 30 days of follow-up
Number of patients taking analgesics until 30 days
Time frame: From the end of the surgery until 30 days of follow up
Mean Score of the EQ-5D-5L Quality of Life
Time frame: From randomization until 3 months after surgery
Evaluation of predictive factors of postoperative pain
Time frame: From the surgery until 30 days of follow up
Evaluation of predictive factors of opioid intake
Time frame: From the surgery until 30 days of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 41888042He J, Pan X. Carbon dioxide laparoscopic technology: research hotspots and innovations in pneumoperitoneum detection. Med Gas Res. 2026 Dec 1;16(4):415-425. doi: 10.4103/mgr.MEDGASRES-D-25-00206. Epub 2026 Mar 26.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Quentin DENOST study director
Bordeaux Colorectal Institute Academy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgery under low pressure and warm and humidified CO2 Insufflation and Laparoscopic surgery under low pressure and conventional Insufflation in people with Colorectal Surgery and Benign or Malignant Rectal or Colon Tumors, run by Bordeaux Colorectal Institute Academy at 2 sites in France.
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 6 inclusion and 21 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: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with pain at 24 hours after the end of the intervention by VAS ≤ 3 without taking opioids (without step 2 and step 3 analgesics). (time frame: At 24 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934981, which also lists 1 linked publication.
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 18 Jun 2026.