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Completed

NCT Number: NCT02773173

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.

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Key information

Conditions

Colorectal Surgery Laparoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital universitario y Politécnico La Fe

Valencia, 46026, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPP in colorectal laparoscopic surgery

Procedure

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 surgery

Procedure

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2016
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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