Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-II)
- Conditions
- Colorectal SurgeryLaparoscopy
- Interventions
- Procedure: SPP in colorectal laparoscopic surgeryProcedure: IPP in colorectal laparoscopic surgery
- Registration Number
- NCT02773173
- Lead Sponsor
- Instituto de Investigacion Sanitaria La Fe
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- Patients older than 18 years
- Classification of the American Society of Anesthesiologists (ASA I-III)
- No cognitive deficits
- Signed informed consent prior to surgery
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Pneumoperitoneum Pressure SPP in colorectal laparoscopic surgery In Standard Pneumoperitoneum Pressure (SPP) group, a conventional operation without optimization measures and PIA preset to 12 mmHg will be conducted. Individualized Pneumoperitoneum Pressure IPP in colorectal laparoscopic surgery In Individualized Pneumoperitoneum Pressure (IPP) group, measures to optimize and individualize intra-abdominal pressure (PIA) will be apply.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Spontaneous / coughing movements . Up to 300 minutes during surgical intervention yes or no
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 volume Up to 300 minutes during surgical intervention Intraabdominal pressures in ml
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
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.
Intraabdominal pressure Up to 300 minutes during surgical intervention Intraabdominal pressures in mm Hg
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).
Trial Locations
- Locations (1)
Hospital universitario y Politécnico La Fe
🇪🇸Valencia, Spain