Colorectal Surgery, Laparoscopy
Conditions
Keywords
Colorectal Laparoscopic Surgery
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.
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.
Interventions
PROCEDUREIPP 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.
PROCEDURESPP 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).
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
neuromuscular blocking agents as type of drug
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative Quality of Recovery Scale (PQRS) Physiologic Domain | 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
| Measure | Time frame | Description |
|---|---|---|
| Daily postoperative complications until hospital discharge (Clavien-Dindo) | Up to postoperative day 28 | Postoperative complications clavien dindo classification |
| Basic features of airway pressures (plateauP, peakP, pulmonary Compliance) | Up to 300 minutes during surgical intervention | Airway pressures in cmH2O |
| Intraabdominal pressure | Up to 300 minutes during surgical intervention | Intraabdominal pressures in mm Hg |
| Chnge Postoperative Quality of Recovery Scale (PQRS) | 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. |
| Spontaneous / coughing movements . | Up to 300 minutes during surgical intervention | yes or no |
| Substudy- Hepatic perfusion during pneumoperitoneum.Plasma disappearance rate of indocyanine green (PDRICG) | Up to 300 minutes during surgical intervention | Plasma disappearance rate of indocyanine green |
| Change in Surgical stress and inflammatory markers | Up to postoperative day 3. This is a longitudinal outcome | (neutrophil/lymphocyte ratio, C-reactive protein,interleukin-6 and procalcitonin). |
| Intraabdominal volume | Up to 300 minutes during surgical intervention | Intraabdominal pressures in ml |
Countries
Spain
Outcome results
None listed