Clinical trial NCT02773173: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-II)
Official title: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Surgery
Laparoscopy
Keywords: Colorectal Laparoscopic Surgery
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: neuromuscular blocking agents as type of drug
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Postoperative Quality of Recovery Scale (PQRS) Physiologic Domain
timeFrame: Up to postoperative day 3. This is a longitudinal outcome.
Secondary outcomes:
measure: Chnge Postoperative Quality of Recovery Scale (PQRS)
timeFrame: Up to postoperative day 3. This is a longitudinal outcome.
measure: Daily postoperative complications until hospital discharge (Clavien-Dindo)
timeFrame: Up to postoperative day 28
measure: Basic features of airway pressures (plateauP, peakP, pulmonary Compliance)
timeFrame: Up to 300 minutes during surgical intervention
measure: Intraabdominal pressure
timeFrame: Up to 300 minutes during surgical intervention
measure: Intraabdominal volume
timeFrame: Up to 300 minutes during surgical intervention
measure: Spontaneous / coughing movements .
timeFrame: Up to 300 minutes during surgical intervention
measure: Substudy- Hepatic perfusion during pneumoperitoneum.Plasma disappearance rate of indocyanine green (PDRICG)
timeFrame: Up to 300 minutes during surgical intervention
measure: Change in Surgical stress and inflammatory markers
timeFrame: Up to postoperative day 3. This is a longitudinal outcome
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital universitario y Politécnico La Fe
Study officials:
affiliation: Instituto de Investigación Sanitaria La Fe
name: Óscar Díaz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.