Colonic DiseaseLoPreColNCT04112654
Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
A study testing Conventional pressure laparoscopy and Low pressure laparoscopy in people with Colonic Disease, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Disease
- What is being tested?
- Conventional pressure laparoscopy and Low pressure laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2020to 18 Oct 2023
- 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
- Colic lesion justifying surgical resection by segmental colectomy,
- Surgery proposed by laparoscopy,
- Body mass index (BMI) ≤30 kg/m2,
- Written informed consent signed by the patient,
- Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen.
Who cannot join
- Probable realization of a stoma during the procedure,
- Robot-assisted approach,
- Contraindication to laparoscopic surgery,
- Pregnant or likely to be pregnant,
- Patient deprived of liberty or placed under the authority of a tutor,
- Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.
- Conditions
- Colonic Disease
- Being tested
- Conventional pressure laparoscopy, Low pressure laparoscopy
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional pressure laparoscopyProcedure or surgery
Conventional pressure laparoscopy using conventional insufflator AirSeal®
Low pressure laparoscopyProcedure or surgery
Low pressure laparoscopy using pressure-controlled insufflator AirSeal®
| Study group | Role | What they receive |
|---|---|---|
| Conventional laparoscopy | Active comparator | Laparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator. Receives: Procedure: Conventional pressure laparoscopy |
| Low pressure laparoscopy | Experimental | Laparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal® Receives: Procedure: Low pressure laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The theoretical hospital stay
The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria)
Measured: from hospitalization day until hospital discharge, assessed up to 15 days
Secondary outcomes (11)
Morbidity rate
Morbidity evaluated according Dindo-clavien classification
Measured: 20 days post surgery
Mortality rate
Dead patient listing
Measured: 20 days post surgery
GastroIntestinal-Quality-of-Life Index (GIQLI)
GastroIntestinal-Quality-of-Life Index (GIQLI) questionnaire, 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.
Measured: 20 days and 3 months post surgery
Short Form Health (SF12) score
This questionnaire is an abbreviated version of the "Medical Outcomes Study Short-Form General Health Survey" (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life).
Measured: 20 days and 3 months post surgery
Pain score using self-report pain assessment tool (EVA)
EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)
Measured: From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery
Intestinal transit recovery time frame
Period duration from surgery to intestinal gas recovery time (in days)
Measured: From surgery to transit recovery assessed up to 15 days
Nausea and vomiting incidence
Nausea and vomiting listing
Measured: From surgery to hospital discharge assessed up to 15 days
Analgesic treatment incidence
Non-morphine and morphine analgesic consumption
Measured: From surgery to 3 months post surgery
Real hospitalization duration
Real hospitalization duration (actual patient discharge date based on non-medical criteria)
Measured: From hospitalization day until hospital discharge assessed up to 15 days
Rehospitalization number
Rehospitalization listing
Measured: from hospital discharge assessed up to 15 days to 3 months post surgery
Differential cost of patient care
According operating room occupation and real hospital stay
Measured: From surgery to hospital discharge assessed up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start29 Jun 2020
- Primary completion7 Jun 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseaseStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecile DE CHAISEMARTIN, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112654
- Sponsor's protocol ID
- LOPRECOL-IPC 2017-02
- Other IDs
- LOPRECOL-IPC 2017-02
- Acronym
- LoPreCol
- Status last verified
- Apr 2024
- First submitted
- 25 Sep 2019
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
- ClinicalTrials.gov ID
- NCT04112654
- Acronym / sponsor ID
- LoPreCol / LOPRECOL-IPC 2017-02
- Conditions
- Colonic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 2 Oct 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.
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional laparoscopy | Active comparator | Procedure: Conventional pressure laparoscopyLaparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator. |
| Low pressure laparoscopy | Experimental | Procedure: Low pressure laparoscopyLaparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Colic lesion justifying surgical resection by segmental colectomy,
- Surgery proposed by laparoscopy,
- Body mass index (BMI) ≤30 kg/m2,
- Written informed consent signed by the patient,
- Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen.
Key exclusion criteria (6 listed)
- Probable realization of a stoma during the procedure,
- Robot-assisted approach,
- Contraindication to laparoscopic surgery,
- Pregnant or likely to be pregnant,
- Patient deprived of liberty or placed under the authority of a tutor,
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 |
|---|---|---|
| Conventional pressure laparoscopyConventional pressure laparoscopy using conventional insufflator AirSeal® | Procedure or surgery | Conventional laparoscopy |
| Low pressure laparoscopyLow pressure laparoscopy using pressure-controlled insufflator AirSeal® | Procedure or surgery | Low pressure laparoscopy |
Primary outcome
The theoretical hospital stay
Time frame: from hospitalization day until hospital discharge, assessed up to 15 days
The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria)
11 secondary outcomes
Morbidity rate
Time frame: 20 days post surgery
Mortality rate
Time frame: 20 days post surgery
GastroIntestinal-Quality-of-Life Index (GIQLI)
Time frame: 20 days and 3 months post surgery
Short Form Health (SF12) score
Time frame: 20 days and 3 months post surgery
Pain score using self-report pain assessment tool (EVA)
Time frame: From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery
Intestinal transit recovery time frame
Time frame: From surgery to transit recovery assessed up to 15 days
Nausea and vomiting incidence
Time frame: From surgery to hospital discharge assessed up to 15 days
Analgesic treatment incidence
Time frame: From surgery to 3 months post surgery
Real hospitalization duration
Time frame: From hospitalization day until hospital discharge assessed up to 15 days
Rehospitalization number
Time frame: from hospital discharge assessed up to 15 days to 3 months post surgery
Differential cost of patient care
Time frame: From surgery to hospital discharge assessed up to 15 days
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 9 Apr 2024.
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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.
Cecile DE CHAISEMARTIN, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional pressure laparoscopy and Low pressure laparoscopy in people with Colonic Disease, run by Institut Paoli-Calmettes 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 6 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 9 Apr 2024. 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?
The theoretical hospital stay (time frame: from hospitalization day until hospital discharge, assessed up to 15 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 9 Apr 2024.