Malignant or Benign PathologyPAROS2NCT04742881
Low Impact Laparoscopic in Colorectal Resection - PAROS2
A study testing Low pressure + microsurgical instruments and Low pressure + standard instruments in people with Malignant or Benign Pathology, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
To improve post-operative recovery, the concept of Low Impact Laparoscopy was developed in colo-rectal surgery with associating low-pressure pneumoperitoneum and microlaparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant or Benign Pathology
- What is being tested?
- Low pressure + microsurgical instruments and Low pressure + standard instruments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Dec 2022to Sep 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled colectomy for malignant or benign pathology
- Right colon: ileocecal resection, right colectomy, right colectomy extended to the middle of the transverse
- Left colon: sigmoidectomy, left colectomy
- Rectal resection without stoma for cancer of the upper rectum
- Patient operable by laparoscopy (classic or robot assisted for the Standard group)
- 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
- Patients with electronic implant (ex : pacemaker)
- Total or Subtotal Colectomy
- Transverse segmental colectomy
- Left angular colectomy
- Proctectomy with stoma or Total Coloproctectomy
Show all 20Show fewer
- Patient with stoma
- Probable realization of a stoma during the operation
- Procedure associated with colorectal surgery (except appendectomy or liver biopsy)
- Crohn's disease, Hemorrhagic Rectocolitis (UC)
- Sigmoiditis
- EVA before surgery> 3
- BMI ≥ 30
- ASA > 3
- 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 (curatorship or guardianship) or unable to give their consent
- Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CH de la Côte Basque
Bayonne
Romain DIDAILLER, rdidailler@ch-cotebasque.fr
- Recruiting
CHU Bordeaux
Bordeaux
Christophe LAURENT, christophe.laurent@chu-bordeaux.fr
- Recruiting
Ch Libourne
Libourne
Thomas PAUMET, thomas.paumet@ch-libourne.fr
About this study
Official title: Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone
To improve post-operative recovery, the concept of Low Impact Laparoscopy was developed in colo-rectal surgery with associating low-pressure pneumoperitoneum and microlaparoscopic surgery. A phase III double-blind, prospective, randomized, controlled, multi-centric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with classical laparoscopic instruments 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) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay and decrease post-operative pain with reduction of analgesic consumption.
Minimally invasive technics like microlaparoscopic surgery, developed last years had also an impact by decreasing post operative pain. The Low Impact Laparoscopy concept was developed in colo-rectal surgery with the association of low-pressure pneumoperitoneum and microlaparoscopic surgery.
The aim of the study is to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain without taking opioids, compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries.
The design of this study is a phase III double-blind, prospective, randomized, controlled, multi-centric trial. The primary endpoint is the rate of patients with postoperative pain defined 24h after the end of the intervention by visual analog scale (VAS) ≤ 3 without taking opioids (analgesics level II or III). Secondary outcomes are operating time, conversion rate in normal pressure laparoscopy or in laparotomy, morbidity at 3 months, quality of oncological surgery, length of stay, impact of microlaparoscopic instruments of aesthetic appearance at 3 months.
The primary end point will be assessed at 24h after the end of the surgery by a blind nurse evaluating the pain intensity. After discharge of the hospital, patients will be followed with postoperative consultation at 1 month and 3 month.
- Conditions
- Malignant or Benign Pathology
- Being tested
- Low pressure + microsurgical instruments, Low pressure + standard instruments
- Keywords
- Colorectal pathology, Laparoscopic, Microsurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low pressure + microsurgical instrumentsProcedure or surgery
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
Low pressure + standard instrumentsProcedure or surgery
Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments)
| Study group | Role | What they receive |
|---|---|---|
| Low pressure + microsurgical instruments | Experimental | Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments) Receives: Procedure: Low pressure + microsurgical instruments |
| Low pressure + standard instruments | Active comparator | Low pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments) Receives: Procedure: Low pressure + standard instruments |
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 NRS ≤ 3 without taking opioids (without pain reliever 2 and 3)
Pain is evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)
Measured: At 24 hours after the end of surgery
Secondary outcomes (13)
Operating time
Measured: During surgery
Conversion rate in normal pressure laparoscopy and or in laparotomy
Measured: During surgery
Intraoperative analgesia nociception index (ANI)
Measured: During surgery
Peri-operative cardiovascular and respiratory components
Measured: During surgery
Time to resume transit and gas
Measured: An average of 5 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 curative surgery R0 resection for oncologic surgery
Measured: During surgery
Number of lymph nodes examined
Number of lymph nodes examined by the pathologist for oncologic surgery
Measured: During surgery
Length of stay in hospital
Measured: From surgery to the end of the hospitalization (max 30 days)
Number of patients with pain at 30 days
Pain was evaluated with the Numeric Rating Scale 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
Impact of microsurgical instruments on the aesthetic appearance
Rate of scar satisfaction at 30days and at 3 months after surgery
Measured: 30 days after surgery and 3 months of follow up
Mean score of the EQ-5D-5L Quality of life
Health related quality of life will be assessed using the Short Form EQ-5D-5L Health Survey questionnaire. The EQ-5D-5L is a generic health status measurement instrument. It is made up of 5 questions and a visual scale. A question for each of the following aspects: mobility, the ability to wash and dress, daily activities, discomfort and pain, anxiety as well as a score for the patient's perception of the quality of life. The questionnaire is administered the day before the surgery and 1 month and 3 months after the surgery.
Measured: From randomization until 3 months 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 posted8 Feb 2021
- Study start14 Dec 2022
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
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 Malignant or Benign PathologyStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe LAURENT, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742881
- Sponsor's protocol ID
- CHUBX 2020/30
- Acronym
- PAROS2
- Status last verified
- May 2025
- First submitted
- 22 Jan 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marichez A, Eude A, Martenot M, Celerier B, Capdepont M, Rullier E, Denost Q, Fernandez B. Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial. Colorectal Dis. 2023 Dec;25(12):2403-2413. doi: 10.1111/codi.16787. Epub 2023 Oct 27.
PubMed 37897108
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Impact Laparoscopic in Colorectal Resection: a Randomized Trial Comparing Low Pneumoperitoneum Pressure Plus Microsurgery Versus Low Pneumoperitoneum Alone
- ClinicalTrials.gov ID
- NCT04742881
- Acronym / sponsor ID
- PAROS2 / CHUBX 2020/30
- Conditions
- Malignant or Benign Pathology
- Keywords
- Colorectal pathology, Laparoscopic, Microsurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Feb 2021 (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, the concept of Low Impact Laparoscopy was developed in colo-rectal surgery with associating low-pressure pneumoperitoneum and microlaparoscopic surgery. A phase III double-blind, prospective, randomized, controlled, multi-centric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with classical laparoscopic instruments 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) which showed that low-pressure laparoscopic colectomy for benign or malign disease was feasible and safe with shorter length of stay and decrease post-operative pain with reduction of analgesic consumption.
Minimally invasive technics like microlaparoscopic surgery, developed last years had also an impact by decreasing post operative pain. The Low Impact Laparoscopy concept was developed in colo-rectal surgery with the association of low-pressure pneumoperitoneum and microlaparoscopic surgery.
The aim of the study is to assess the impact of low-pressure pneumoperitoneum with microlaparoscopic instruments on post-operative pain without taking opioids, compared with low-pressure laparoscopy with classical laparoscopic instruments in patients undergoing colorectal surgeries.
The design of this study is a phase III double-blind, prospective, randomized, controlled, multi-centric trial. The primary endpoint is the rate of patients with postoperative pain defined 24h after the end of the intervention by visual analog scale (VAS) ≤ 3 without taking opioids (analgesics level II or III). Secondary outcomes are operating time, conversion rate in normal pressure laparoscopy or in laparotomy, morbidity at 3 months, quality of oncological surgery, length of stay, impact of microlaparoscopic instruments of aesthetic appearance at 3 months.
The primary end point will be assessed at 24h after the end of the surgery by a blind nurse evaluating the pain intensity. After discharge of the hospital, patients will be followed with postoperative consultation at 1 month and 3 month.
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 + microsurgical instruments | Experimental | Procedure: Low pressure + microsurgical instrumentsLow pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments) |
| Low pressure + standard instruments | Active comparator | Procedure: Low pressure + standard instrumentsLow pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Scheduled colectomy for malignant or benign pathology
- Right colon: ileocecal resection, right colectomy, right colectomy extended to the middle of the transverse
- Left colon: sigmoidectomy, left colectomy
- Rectal resection without stoma for cancer of the upper rectum
- Patient operable by laparoscopy (classic or robot assisted for the Standard group)
Key exclusion criteria (20 listed)
- Laparotomy procedure
- Patients with electronic implant (ex : pacemaker)
- Total or Subtotal Colectomy
- Transverse segmental colectomy
- Left angular colectomy
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 |
|---|---|---|
| Low pressure + microsurgical instrumentsLow pressure pneumoperitoneum ((≤ 8 mmHg) and use of microsurgical instruments (3mm and 5mm instruments) | Procedure or surgery | Low pressure + microsurgical instruments |
| Low pressure + standard instrumentsLow pressure pneumoperitoneum ((≤ 8 mmHg) and use of standard instruments (5mm and 10mm instruments) | Procedure or surgery | Low pressure + standard instruments |
Primary outcome
Number of patients with pain at 24 hours after the end of the intervention by NRS ≤ 3 without taking opioids (without pain reliever 2 and 3)
Time frame: At 24 hours after the end of surgery
Pain is evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)
13 secondary outcomes
Operating time
Time frame: During surgery
Conversion rate in normal pressure laparoscopy and or in laparotomy
Time frame: During surgery
Intraoperative analgesia nociception index (ANI)
Time frame: During surgery
Peri-operative cardiovascular and respiratory components
Time frame: During surgery
Time to resume transit and gas
Time frame: An average of 5 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
Number of lymph nodes examined
Time frame: During surgery
Length of stay in hospital
Time frame: From surgery to the end of the hospitalization (max 30 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
Impact of microsurgical instruments on the aesthetic appearance
Time frame: 30 days after surgery and 3 months of follow up
Mean score of the EQ-5D-5L Quality of life
Time frame: From randomization until 3 months of follow up
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 22 May 2025.
- Derived from this study: PubMed 37897108Marichez A, Eude A, Martenot M, Celerier B, Capdepont M, Rullier E, Denost Q, Fernandez B. Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial. Colorectal Dis. 2023 Dec;25(12):2403-2413. doi: 10.1111/codi.16787. Epub 2023 Oct 27.
Related trials for Malignant or Benign Pathology
RecruitingObservational study
Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)
Colorectal Surgery, Benign or Malignant Rectal or Colon Tumors
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.
Christophe LAURENT principal investigator
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low pressure + microsurgical instruments and Low pressure + standard instruments in people with Malignant or Benign Pathology, run by University Hospital, Bordeaux at 3 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 8 inclusion and 20 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 Christophe LAURENT (+33 (0)5 56 79 58 10, christophe.laurent@chu-bordeaux.fr), or a site near the patient. 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 NRS ≤ 3 without taking opioids (without pain reliever 2 and 3) (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 NCT04742881, 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 22 May 2025.