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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773173
• Other study ID #: IPPCollapse-II
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2017
• Est. completion date: November 19, 2018

Study information

• Verified date: August 2019
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• Laparoscopy
• Pneumoperitoneum

Intervention

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.
• 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).

Locations

Country	Name	City	State
Spain	Hospital universitario y Politécnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Daily postoperative complications until hospital discharge (Clavien-Dindo)	Postoperative complications clavien dindo classification	Up to postoperative day 28
Secondary	Basic features of airway pressures (plateauP, peakP, pulmonary Compliance)	Airway pressures in cmH2O	Up to 300 minutes during surgical intervention
Secondary	Intraabdominal pressure	Intraabdominal pressures in mm Hg	Up to 300 minutes during surgical intervention
Secondary	Intraabdominal volume	Intraabdominal pressures in ml	Up to 300 minutes during surgical intervention
Secondary	Spontaneous / coughing movements .	yes or no	Up to 300 minutes during surgical intervention
Secondary	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
Secondary	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