Malignant or Benign PathologyPAROSNCT03813797
LaPAroscopic Low pRessure cOlorectal Surgery
A study testing Airseal® and Standard Insufflation in people with Malignant or Benign Pathology, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). 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?
- Airseal® and Standard Insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2019to 26 Jun 2020
- 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
- Age ≥ 18
- Colonic resection (right or left) performed for benign or malignant pathology
- Laparoscopic procedure
- Informed consent signed
- Social Insurance
Who cannot join
- Laparotomy procedure
- Associated resection (except appendectomy or liver biopsy
- Emergency procedure
- Pelvic sepsis
- Pregnant or breast-feeding woman.
- Persons deprived of liberty or under guardianship
- Impossibility for compliance to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is described in the literature for 15 years as the best way to reduce scapular pain, but until the marketing of Airseal, working at 7mmHg was not possible because the space of work was not stable. Moreover, this device makes it possible to obtain a better vision because of the evacuation of the fumes potentially leading to a reduction in the operating time.
Read the detailed description
This research focuses on a medical device that allows the surgeon to perform the surgical procedure at a lower pressure than usual.
The main objective of this study is to compare the duration of hospitalization of patients with laparoscopic colectomy at low pressure (5-7 mmHg) versus standard pressure (12-15 mmHg) It is a prospective randomized monocentric double blind study
- Conditions
- Malignant or Benign Pathology
- Being tested
- Airseal®, Standard Insufflation
- Keywords
- Low Pressure, Laparoscopy, Colectomy, Pneumoperitoneum, AirSeal
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airseal®Device
Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
Standard InsufflationDevice
Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Low Pressure (5-7 mmHg) | Experimental | Laparoscopic colectomy surgery with low pressure (5-7mmHg) Receives: Device: Airseal® |
| Arm B: Standard pressure (12-15 mmHg) | Active comparator | Laparoscopic colectomy surgery with standard pressure (12-15mmHg) Receives: Device: Standard Insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
To determine the length of hospitalization
Measured: From surgery to the end of the hospitalization (max 30 days)
Secondary outcomes (18)
Surgery time
To determine the surgery time
Measured: During surgery
Appreciation of visual quality by surgeon
To determine the rate of visual quality during surgery: poor, medium or good quality
Measured: During surgery
Impact of the use of microlaparoscopic instruments
To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm)
Measured: During surgery
Rates of conversion
Conversion to laparoscopy with standard pressure or conversion to laparotomy
Measured: During surgery
Blood pressure (mmHg)
To examine the variation of blood pressure during surgery (at the beginning, middle and at the end)
Measured: During surgery
Cardiac frequency (/ min)
To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end)
Measured: During surgery
Volume replacement (mL)
To examine the volume replacement during surgery (at the beginning, middle and at the end)
Measured: During surgery
Driving pressure (mmHg)
To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end)
Measured: During surgery
Oxygen saturation (%)
To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end)
Measured: During surgery
Partial pressure of mean expired of carbon dioxide (mmHg)
To examine the variation PECO2 (mmHg) during surgery (at the beginning, middle and at the end)
Measured: During surgery
Surgical and medical morbidity
To analyse the cumulative Clavien-Dindo at 30 days
Measured: From surgery until 30 days (max 45 days)
Postoperative pain
Pain was evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)
Measured: 2 hours, 4 hours, 8 hours and 24 hours after the surgery
Use of analgesics
To evaluate the rate of analgesics administrated (from step1 to step3)
Measured: An average of 5 days after the surgery
Time before the passage of first stool (days)
To determine the delay of the laxation and gas response
Measured: An average of 5 days after the surgery
Time before the passage of first gas (days)
To determine the delay of the gas response
Measured: An average of 5 days after the surgery
Time before mobilization (Days before 1st time sitting and standing)
To determine the delay before mobilization
Measured: An average of 5 days after the surgery
Quality of cancer surgery
Rate of curative surgery (R0)
Measured: During surgery
Number of lymph nodes examed
Number of lymph nodes examed during a cancer surgery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start7 Jan 2019
- Primary completion25 May 2020
- Study completion26 Jun 2020
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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quentin DENOST, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813797
- Sponsor's protocol ID
- CHUBX 2018/42
- Acronym
- PAROS
- Status last verified
- Oct 2020
- First submitted
- 8 Jan 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celarier S, Monziols S, Celerier B, Assenat V, Carles P, Napolitano G, Laclau-Lacrouts M, Rullier E, Ouattara A, Denost Q. Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial. Br J Surg. 2021 Aug 19;108(8):998-1005. doi: 10.1093/bjs/znab069.
PubMed 33755088
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LaPAroscopic Low pRessure cOlorectal Surgery
- ClinicalTrials.gov ID
- NCT03813797
- Acronym / sponsor ID
- PAROS / CHUBX 2018/42
- Conditions
- Malignant or Benign Pathology
- Keywords
- Low Pressure, Laparoscopy, Colectomy, Pneumoperitoneum, AirSeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 23 Jan 2019 (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.
Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is described in the literature for 15 years as the best way to reduce scapular pain, but until the marketing of Airseal, working at 7mmHg was not possible because the space of work was not stable. Moreover, this device makes it possible to obtain a better vision because of the evacuation of the fumes potentially leading to a reduction in the operating time.
Detailed description
This research focuses on a medical device that allows the surgeon to perform the surgical procedure at a lower pressure than usual.
The main objective of this study is to compare the duration of hospitalization of patients with laparoscopic colectomy at low pressure (5-7 mmHg) versus standard pressure (12-15 mmHg) It is a prospective randomized monocentric double blind study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Low Pressure (5-7 mmHg) | Experimental | Device: Airseal®Laparoscopic colectomy surgery with low pressure (5-7mmHg) |
| Arm B: Standard pressure (12-15 mmHg) | Active comparator | Device: Standard InsufflationLaparoscopic colectomy surgery with standard pressure (12-15mmHg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Colonic resection (right or left) performed for benign or malignant pathology
- Laparoscopic procedure
- Informed consent signed
- Social Insurance
Key exclusion criteria (7 listed)
- Laparotomy procedure
- Associated resection (except appendectomy or liver biopsy
- Emergency procedure
- Pelvic sepsis
- Pregnant or breast-feeding woman.
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 |
|---|---|---|
| Airseal®Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg | Device | Arm A: Low Pressure (5-7 mmHg) |
| Standard InsufflationMedical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg | Device | Arm B: Standard pressure (12-15 mmHg) |
Primary outcome
Length of postoperative hospital stay
Time frame: From surgery to the end of the hospitalization (max 30 days)
To determine the length of hospitalization
18 secondary outcomes
Surgery time
Time frame: During surgery
Appreciation of visual quality by surgeon
Time frame: During surgery
Impact of the use of microlaparoscopic instruments
Time frame: During surgery
Rates of conversion
Time frame: During surgery
Blood pressure (mmHg)
Time frame: During surgery
Cardiac frequency (/ min)
Time frame: During surgery
Volume replacement (mL)
Time frame: During surgery
Driving pressure (mmHg)
Time frame: During surgery
Oxygen saturation (%)
Time frame: During surgery
Partial pressure of mean expired of carbon dioxide (mmHg)
Time frame: During surgery
Surgical and medical morbidity
Time frame: From surgery until 30 days (max 45 days)
Postoperative pain
Time frame: 2 hours, 4 hours, 8 hours and 24 hours after the surgery
Use of analgesics
Time frame: An average of 5 days after the surgery
Time before the passage of first stool (days)
Time frame: An average of 5 days after the surgery
Time before the passage of first gas (days)
Time frame: An average of 5 days after the surgery
Time before mobilization (Days before 1st time sitting and standing)
Time frame: An average of 5 days after the surgery
Quality of cancer surgery
Time frame: During surgery
Number of lymph nodes examed
Time frame: During surgery
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 8 Oct 2020.
- Derived from this study: PubMed 33755088Celarier S, Monziols S, Celerier B, Assenat V, Carles P, Napolitano G, Laclau-Lacrouts M, Rullier E, Ouattara A, Denost Q. Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial. Br J Surg. 2021 Aug 19;108(8):998-1005. doi: 10.1093/bjs/znab069.
- Individual participant dataSharing planned: No
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
Recruiting
Low Impact Laparoscopic in Colorectal Resection - PAROS2
Malignant or Benign Pathology
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 principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airseal® and Standard Insufflation in people with Malignant or Benign Pathology, run by University Hospital, Bordeaux at 1 site 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 5 inclusion and 7 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Length of postoperative hospital stay (time frame: From 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?
On the ClinicalTrials.gov record for NCT03813797, 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 8 Oct 2020.