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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Laparoscopy
• Intervention / Treatment: Procedure: IPP in colorectal laparoscopic surgery; Procedure: SPP in colorectal laparoscopic surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Hospital Universitario Y Politecnico La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.
OTHER: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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' .	Up to postoperative day 3. This is a longitudinal outcome.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to postoperative day 3. This is a longitudinal outcome.
Daily postoperative complications until hospital discharge (Clavien-Dindo)	Postoperative complications clavien dindo classification	Up to postoperative day 28
Basic features of airway pressures (plateauP, peakP, pulmonary Compliance)	Airway pressures in cmH2O	Up to 300 minutes during surgical intervention
Intraabdominal pressure	Intraabdominal pressures in mm Hg	Up to 300 minutes during surgical intervention
Intraabdominal volume	Intraabdominal pressures in ml	Up to 300 minutes during surgical intervention
Spontaneous / coughing movements .	yes or no	Up to 300 minutes during surgical intervention
Substudy- Hepatic perfusion during pneumoperitoneum.Plasma disappearance rate of indocyanine green (PDRICG)	Plasma disappearance rate of indocyanine green	Up to 300 minutes during surgical intervention
Change in Surgical stress and inflammatory markers	(neutrophil/lymphocyte ratio, C-reactive protein,interleukin-6 and procalcitonin).	Up to postoperative day 3. This is a longitudinal outcome

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Investigators: Principal Investigator: Óscar Díaz, Instituto de Investigacion Sanitaria La Fe

Publications and helpful links

General 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.
• 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. Erratum In: Trials. 2020 Jan 13;21(1):70.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2017
• Primary Completion (ACTUAL): November 19, 2018
• Study Completion (ACTUAL): November 19, 2018

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (ESTIMATE): May 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Colorectal Laparoscopic Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: IPPCollapse-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No