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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773173
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Surgery Laparoscopy Procedure: IPP in colorectal laparoscopic surgery Procedure: SPP in colorectal laparoscopic surgery Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: neuromuscular blocking agents as type of drug
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse II)
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Arm Intervention/treatment
Experimental: Individualized Pneumoperitoneum Pressure
In Individualized Pneumoperitoneum Pressure (IPP) group, measures to optimize and individualize intra-abdominal pressure (PIA) will be apply.
Procedure: IPP in colorectal laparoscopic 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.

Standard Pneumoperitoneum Pressure
In Standard Pneumoperitoneum Pressure (SPP) group, a conventional operation without optimization measures and PIA preset to 12 mmHg will be conducted.
Procedure: SPP in colorectal laparoscopic 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).




Primary Outcome Measures :
  1. Change in Postoperative Quality of Recovery Scale (PQRS) Physiologic Domain [ Time Frame: Up to postoperative day 3. This is a longitudinal outcome. ]
    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' .


Secondary Outcome Measures :
  1. Chnge Postoperative Quality of Recovery Scale (PQRS) [ Time Frame: Up to postoperative day 3. This is a longitudinal outcome. ]
    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.

  2. Daily postoperative complications until hospital discharge (Clavien-Dindo) [ Time Frame: Up to postoperative day 28 ]
    Postoperative complications clavien dindo classification

  3. Basic features of airway pressures (plateauP, peakP, pulmonary Compliance) [ Time Frame: Up to 300 minutes during surgical intervention ]
    Airway pressures in cmH2O

  4. Intraabdominal pressure [ Time Frame: Up to 300 minutes during surgical intervention ]
    Intraabdominal pressures in mm Hg

  5. Intraabdominal volume [ Time Frame: Up to 300 minutes during surgical intervention ]
    Intraabdominal pressures in ml

  6. Spontaneous / coughing movements . [ Time Frame: Up to 300 minutes during surgical intervention ]
    yes or no

  7. Substudy- Hepatic perfusion during pneumoperitoneum.Plasma disappearance rate of indocyanine green (PDRICG) [ Time Frame: Up to 300 minutes during surgical intervention ]
    Plasma disappearance rate of indocyanine green

  8. Change in Surgical stress and inflammatory markers [ Time Frame: Up to postoperative day 3. This is a longitudinal outcome ]
    (neutrophil/lymphocyte ratio, C-reactive protein,interleukin-6 and procalcitonin).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773173


Locations
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Spain
Hospital universitario y Politécnico La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Principal Investigator: Óscar Díaz Instituto de Investigación Sanitaria La Fe
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT02773173    
Other Study ID Numbers: IPPCollapse-II
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Colorectal Laparoscopic Surgery
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases