AzTrials
AzTrials

Colorectal SurgeryPhase 4NCT02773173

Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-II)

A Phase 4 study testing IPP in colorectal laparoscopic surgery and SPP in colorectal laparoscopic surgery in people with Colorectal Surgery and Laparoscopy, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the post-operative recovery quality of the Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery of their stay in the Post-Anaesthesia Recovery Unit. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Surgery, Laparoscopy
What is being tested?
IPP in colorectal laparoscopic surgery and SPP in colorectal laparoscopic surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteSpain
Study dates
25 Jan 2017to 19 Nov 2018
Phase
Phase 4
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

  • Patients older than 18 years
  • Classification of the American Society of Anesthesiologists (ASA I-III)
  • No cognitive deficits
  • Signed informed consent prior to surgery

Who cannot join

  • Emergency surgery
  • Pregnancy or lactation
  • Immune disorders
  • Kidney or liver disease or advanced-stage cardiopulmonary
  • Patient refusal to participate in the study
  • Patients under 18 years or inability to consent
  • Associated neuromuscular disorders, contraindication for the use of rocuronium/ sugammadex, allergy or hypersensitivity to rocuronium / sugammadex

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital universitario y Politécnico La Fe

    Valencia, 46026

Other trials in Spain

About this study

Official title: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse II)

The purpose of this study is to assess the post-operative recovery quality of the Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery of their stay in the Post-Anaesthesia Recovery Unit.

Read the detailed description

In the last two decades laparoscopic surgery has settled as a less invasive surgical approach compared to open surgery. It is associated with lower perioperative morbidity and hospital stay. There is growing evidence that increased intra-abdominal pressure (IAP), even for short periods of time, is associated with increased perioperative morbidity (pain, increased inflammatory markers peritoneal injury worse splanchnic perfusion abnormalities hemodynamic and ventilatory ...).

The study is a prospective multicenter randomized clinical intervention trial to assess the impact of IAP individualization strategy (IPP-Individualized pneumoperitoneum Pressure) relative to a IAP standard strategy (SPP-Standard pneumoperitoneum Pressure) using a validated scale (VAS) (PQRS- Postoperative Quality of Recovery Scale). Postoperative pain in the first 24 hours (area under VAS curve , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/lymphocyte, ratio,C-reactive protein, interleukin-6, procalcitonin) are also measured. Postoperative complications are evaluated by Clavier-Dindo classification.

Being tested
IPP in colorectal laparoscopic surgery, SPP in colorectal laparoscopic surgery
Keywords
Colorectal Laparoscopic Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPP in colorectal laparoscopic surgeryProcedure or surgery

    Deep neuromuscular blockade can only be reversed with sugammadex, so in the IPP group, it will be used as neuromuscular blocking agent and its effect will be reversed with sugammadex (4mg / kg) at the end of the surgery. During surgery: deep neuromuscular blockade (PTC 1-5), Protective ventilation strategy, Optimal position and Pre stretching as a tool to decrease intraabdominal pressure maintaining optimal workspace.

  • SPP in colorectal laparoscopic surgeryProcedure or surgery

    A depolarizing neuromuscular blocking will be used (as routine clinical practice at each center) to maintain moderate neuromuscular blockade and its effect will be reversed with anticholinesterase at the end of the surgery. During surgery: Moderate neuromuscular blockade ( TOF 2-4) , position to surgeon criteria, no prestretching and Protective ventilation. Fixed IAP (12mmHg).

Study groups in NCT02773173
Study groupRoleWhat they receive
Individualized Pneumoperitoneum PressureExperimentalIn Individualized Pneumoperitoneum Pressure (IPP) group, measures to optimize and individualize intra-abdominal pressure (PIA) will be apply.
Receives: Procedure: IPP in colorectal laparoscopic surgery
Standard Pneumoperitoneum PressureOtherIn Standard Pneumoperitoneum Pressure (SPP) group, a conventional operation without optimization measures and PIA preset to 12 mmHg will be conducted.
Receives: Procedure: SPP in colorectal laparoscopic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Postoperative Quality of Recovery Scale (PQRS) Physiologic Domain

    The primary outcome of the IPPCollapse II study is the recovery of the Physiologic' component of the PQRS score over the assessed time points. The PQRS is a validated multidimensional patient Reported Outcome (PRO) tool designed to assess patients' recovery to baseline status in the postoperative period (www.postopqrs.com). In every patient a baseline measurement of PQRS is performed prior to surgery. After surgery, the measurement of the PQRS is repeated at 15 min (T15) and at 40 min (T40) after arrival in the PACU, as well as in the ward on the morning of postoperative day ( POD) one and three. Physiologic domain includes 9 variables scored from 1-3, 9 is the minimum and worse recover and 27 is the maximum and full recover. But recovery is related to baseline. Each patient is scored at the predefined time points and is classified as either 'recovered' if the score reaches at least the predetermined baseline score or 'not recovered' .

    Measured: Up to postoperative day 3. This is a longitudinal outcome.

Secondary outcomes (8)

  1. Chnge Postoperative Quality of Recovery Scale (PQRS)

    The PQRS domains, 'nociceptive', 'emotional', 'cognitive', and 'functional' components, as well as the 'overall score' are used as secondary outcomes. In every patient a baseline measurement of PQRS is performed prior to surgery. After surgery, the measurement of the PQRS is repeated at 15 min (T15) and at 40 min (T40) after arrival in the PACU, as well as in the ward on the morning of postoperative day ( POD) one and three. Nociceptive and emotional domains are scored from 1-5 ( from worse to better) and include 4 variables. Functional domain is scored from 1-3 ( From worse to better) and include 4 variables, and cognitive is depicted as recover or not versus baseline score.

    Measured: Up to postoperative day 3. This is a longitudinal outcome.

  2. Daily postoperative complications until hospital discharge (Clavien-Dindo)

    Postoperative complications clavien dindo classification

    Measured: Up to postoperative day 28

  3. Basic features of airway pressures (plateauP, peakP, pulmonary Compliance)

    Airway pressures in cmH2O

    Measured: Up to 300 minutes during surgical intervention

  4. Intraabdominal pressure

    Intraabdominal pressures in mm Hg

    Measured: Up to 300 minutes during surgical intervention

  5. Intraabdominal volume

    Intraabdominal pressures in ml

    Measured: Up to 300 minutes during surgical intervention

  6. Spontaneous / coughing movements .

    yes or no

    Measured: Up to 300 minutes during surgical intervention

  7. Substudy- Hepatic perfusion during pneumoperitoneum.Plasma disappearance rate of indocyanine green (PDRICG)

    Plasma disappearance rate of indocyanine green

    Measured: Up to 300 minutes during surgical intervention

  8. Change in Surgical stress and inflammatory markers

    (neutrophil/lymphocyte ratio, C-reactive protein,interleukin-6 and procalcitonin).

    Measured: Up to postoperative day 3. This is a longitudinal outcome

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2016 (estimated)
  2. Study start25 Jan 2017
  3. Primary completion19 Nov 2018
  4. Study completion19 Nov 2018

Resources

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
neuromuscular blocking agents as type of drug
Masking
Single blind
Who is masked
Participant
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02773173
Sponsor's protocol ID
IPPCollapse-II
Status last verified
Aug 2019
First submitted
2 May 2016
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Diaz-Cambronero O, Mazzinari G, Flor Lorente B, Garcia Gregorio N, Robles-Hernandez D, Olmedilla Arnal LE, Martin de Pablos A, Schultz MJ, Errando CL, Argente Navarro MP; IPPColLapSe II study investigators. Effect of an individualized versus standard pneumoperitoneum pressure strategy on postoperative recovery: a randomized clinical trial in laparoscopic colorectal surgery. Br J Surg. 2020 Nov;107(12):1605-1614. doi: 10.1002/bjs.11736. Epub 2020 Jun 7.

    PubMed 32506481

  • Diaz-Cambronero O, Mazzinari G, Errando CL, Schultz MJ, Flor Lorente B, Garcia-Gregorio N, Vila Montanes M, Robles-Hernandez D, Olmedilla Arnal LE, Martin-De-Pablos A, Marques Mari A, Argente Navarro MP; IPPCollapse-II study group. An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study. Trials. 2019 Apr 3;20(1):190. doi: 10.1186/s13063-019-3255-1.

    PubMed 30944044

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IPP in colorectal laparoscopic surgery and SPP in colorectal laparoscopic surgery in people with Colorectal Surgery and Laparoscopy, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.

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 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 15 Apr 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 Spain. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in Postoperative Quality of Recovery Scale (PQRS) Physiologic Domain (time frame: Up to postoperative day 3. This is a longitudinal outcome.). 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 NCT02773173, which also lists 2 linked publications.

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 15 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in