NCT02773173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2018

Completed
Last Updated

April 15, 2020

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

May 2, 2016

Last Update Submit

April 14, 2020

Conditions

Colorectal SurgeryLaparoscopy

Keywords

Colorectal Laparoscopic Surgery

Outcome Measures

Primary Outcomes (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' .

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

Secondary Outcomes (8)

  • Chnge Postoperative Quality of Recovery Scale (PQRS)

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

  • Daily postoperative complications until hospital discharge (Clavien-Dindo)

    Up to postoperative day 28

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

    Up to 300 minutes during surgical intervention

  • Intraabdominal pressure

    Up to 300 minutes during surgical intervention

  • Intraabdominal volume

    Up to 300 minutes during surgical intervention

  • +3 more secondary outcomes

Study Arms (2)

Individualized Pneumoperitoneum Pressure

EXPERIMENTAL

In Individualized Pneumoperitoneum Pressure (IPP) group, measures to optimize and individualize intra-abdominal pressure (PIA) will be apply.

Procedure: IPP in colorectal laparoscopic surgery

Standard Pneumoperitoneum Pressure

OTHER

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

Interventions

IPP in colorectal laparoscopic surgeryPROCEDURE

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.

Individualized Pneumoperitoneum Pressure
SPP in colorectal laparoscopic surgeryPROCEDURE

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).

Standard Pneumoperitoneum Pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Related Publications (2)

  • 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.

    PMID: 32506481DERIVED

  • 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. doi: 10.1186/s13063-020-4055-3.

    PMID: 30944044DERIVED

MeSH Terms

Interventions

indolepropanol phosphatesignal peptide peptidase

Study Officials

  • Óscar Díaz

    Instituto de Investigación Sanitaria La Fe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: neuromuscular blocking agents as type of drug
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 16, 2016

Study Start

January 25, 2017

Primary Completion

November 19, 2018

Study Completion

November 19, 2018

Last Updated

April 15, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)