Individualized Pneumoperitoneum PressureIPPCollapseINCT03000465
Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery
An observational study of Individualized Pneumoperitoneum Pressure, run by Hospital Universitario La Fe.
Trial summary
Optimizing all factors that increase the intra-abdominal volume and performing an individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared to the standard strategy of maintaining fixed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Individualized Pneumoperitoneum Pressure
- What is being tested?
- Laparoscopic colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2016
- Phase
- Observational
- 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
Study population: Patients undergoing colorectal laparoscopic surgery. Patients will be excluded of the analysis if the surgery cannot be finished by laparoscopy,
Who may be able to join
- Over 18 years of age
- ASA I-III (American Society of Anesthesiologists physical status classification)
- Signed informed consent
- Absence of cognitive deficit
Who cannot join
- Urgent surgery
- Pregnancy or breastfeeding
- Immune Disorder
- Advanced renal, hepatic or cardiopulmonary disease
- Negative to participate in the study
- Under 18 years
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- Inability to give consent
- Associated neuromuscular disorders
- Allergy to rocuronium/sugammadex
- Contraindication for use of rocuronium/sugammadex
About this study
Official title: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-I)
Optimizing all factors that increase the intra-abdominal volume and performing an individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15 mmHg).
Read the detailed description
In the context of multimodal rehabilitation in colorectal laparoscopic surgery (Fast Track or ERAS (Enhance Recovery After Surgery)) multiple strategies have been introduced that have managed to improve patient recovery, decrease postoperative complications, decrease hospital days and decrease the overall costs per process.
The possibility of performing individualized colorectal laparoscopic surgery with the minimum insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and this would allow us to reduce the impact of surgery on the patient, decrease perioperative morbidity and improve patient recovery.
In our study, abdominal compliance, Pv0 and maximal Pv were determined during the initial performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of intra-abdominal pressure (IAP) insufflation was stablished with evaluation by the surgeons, until reaching the minimal insufflation IAP in which optimal surgical conditions are maintained.
- Conditions
- Individualized Pneumoperitoneum Pressure
- Being tested
- Laparoscopic colorectal surgery
- Keywords
- pneumoperitoneum pressure, laparoscopic pressure, intra-abdominal insufflation, intra-abdominal pressures, abdominal compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic colorectal surgeryProcedure or surgery
Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients undergoing laparoscopic colorectal surgery Receives: Procedure: Laparoscopic colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal intra-abdominal pressure
To obtain values of intra-abdominal pressure level of minimum insufflation that guarantees optimal surgical conditions following an individualized strategy [mmHg].
Measured: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Secondary outcomes (7)
Ventilation pattern pressure
Airway pressures at different levels of IAP (peak pressure, PEEP (positive end expiratory pressure), plateau pressure, driving pressure) [mmH2O].
Measured: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Intra-abdominal pressures (Pv0, maximal IAP)
Pv0 (IAP with volume 0) and maximal IAP [mmHg].
Measured: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Intra-abdominal pressures (abdominal compliance).
Dynamic abdominal compliance per liter (DV/DP, difference in volume/difference in pressure [L/mmHg]).
Measured: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Surgeon skills and experience
Previous experience of the surgeon in laparoscopic surgery, annual cases, years of experience, previous experience with low IAP.
Measured: Years of experience, up to 10 years.
Duration of surgery
Duration of surgery in minutes from incision to abdominal wall closure.
Measured: The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes.
Postoperative complications
Evolution and complications in the postoperative period: Postoperative pain in the first 24 hours. Postoperative complications were assessed using the Clavier-Dindo classification.
Measured: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.
Hospital stay
Hospital stay in days
Measured: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionOct 2016
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 Individualized Pneumoperitoneum PressureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
- Investigators
- Oscar Diaz Cambronero, Principal investigator, Physician, Specialist in Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000465
- Sponsor's protocol ID
- 2015/0094
- Acronym
- IPPCollapseI
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Diaz-Cambronero O, Flor Lorente B, Mazzinari G, Vila Montanes M, Garcia Gregorio N, Robles Hernandez D, Olmedilla Arnal LE, Argente Navarro MP, Schultz MJ, Errando CL; IPPColLapSe study group. A multifaceted individualized pneumoperitoneum strategy for laparoscopic colorectal surgery: a multicenter observational feasibility study. Surg Endosc. 2019 Jan;33(1):252-260. doi: 10.1007/s00464-018-6305-y. Epub 2018 Jun 27.
PubMed 29951750
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-I)
- ClinicalTrials.gov ID
- NCT03000465
- Acronym / sponsor ID
- IPPCollapseI / 2015/0094
- Conditions
- Individualized Pneumoperitoneum Pressure
- Keywords
- pneumoperitoneum pressure, laparoscopic pressure, intra-abdominal insufflation, intra-abdominal pressures, abdominal compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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.
Optimizing all factors that increase the intra-abdominal volume and performing an individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15 mmHg).
Detailed description
In the context of multimodal rehabilitation in colorectal laparoscopic surgery (Fast Track or ERAS (Enhance Recovery After Surgery)) multiple strategies have been introduced that have managed to improve patient recovery, decrease postoperative complications, decrease hospital days and decrease the overall costs per process.
The possibility of performing individualized colorectal laparoscopic surgery with the minimum insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and this would allow us to reduce the impact of surgery on the patient, decrease perioperative morbidity and improve patient recovery.
In our study, abdominal compliance, Pv0 and maximal Pv were determined during the initial performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of intra-abdominal pressure (IAP) insufflation was stablished with evaluation by the surgeons, until reaching the minimal insufflation IAP in which optimal surgical conditions are maintained.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Laparoscopic colorectal surgeryPatients undergoing laparoscopic colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colorectal laparoscopic surgery. Patients will be excluded of the analysis if the surgery cannot be finished by laparoscopy,
Key inclusion criteria (4 listed)
- Over 18 years of age
- ASA I-III (American Society of Anesthesiologists physical status classification)
- Signed informed consent
- Absence of cognitive deficit
Key exclusion criteria (10 listed)
- Urgent surgery
- Pregnancy or breastfeeding
- Immune Disorder
- Advanced renal, hepatic or cardiopulmonary disease
- Negative to participate in the study
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 colorectal surgeryMinimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy | Procedure or surgery | Patients |
Primary outcome
Minimal intra-abdominal pressure
Time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
To obtain values of intra-abdominal pressure level of minimum insufflation that guarantees optimal surgical conditions following an individualized strategy [mmHg].
7 secondary outcomes
Ventilation pattern pressure
Time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Intra-abdominal pressures (Pv0, maximal IAP)
Time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Intra-abdominal pressures (abdominal compliance).
Time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Surgeon skills and experience
Time frame: Years of experience, up to 10 years.
Duration of surgery
Time frame: The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes.
Postoperative complications
Time frame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.
Hospital stay
Time frame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 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 22 Dec 2016.
- Derived from this study: PubMed 29951750Diaz-Cambronero O, Flor Lorente B, Mazzinari G, Vila Montanes M, Garcia Gregorio N, Robles Hernandez D, Olmedilla Arnal LE, Argente Navarro MP, Schultz MJ, Errando CL; IPPColLapSe study group. A multifaceted individualized pneumoperitoneum strategy for laparoscopic colorectal surgery: a multicenter observational feasibility study. Surg Endosc. 2019 Jan;33(1):252-260. doi: 10.1007/s00464-018-6305-y. Epub 2018 Jun 27.
- Individual participant dataSharing planned: Undecided
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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.
Oscar Diaz Cambronero principal investigator
Physician, Specialist in Anesthesiology
Questions about this trial
What is this clinical trial studying?
An observational study of Individualized Pneumoperitoneum Pressure, run by Hospital Universitario La Fe.
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 4 inclusion and 10 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 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Minimal intra-abdominal pressure (time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.). 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 NCT03000465, 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 Dec 2016.