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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Instituto de Investigacion Sanitaria La Fe

Current Primary Outcome:

  • Postoperative Quality of Recovery Scale (PQRS) [ Time Frame: Baseline and after admission to PACU (postanesthesia care unit) at 15 minutes (T15) ]
  • Postoperative Quality of Recovery Scale (PQRS) [ Time Frame: Baseline and after admission to PACU (postanesthesia care unit) at 40 minutes (T40) . ]
  • Postoperative Quality of Recovery Scale (PQRS) [ Time Frame: Postoperatively on day 1 (POD1). ]
  • Postoperative Quality of Recovery Scale (PQRS) [ Time Frame: Postoperatively on day 3 (POD3). ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patients characteristics (demographic data) [ Time Frame: Day 0 ]
  • Previous experience with low IAP [ Time Frame: Day 0 ]
  • Duration of laparoscopic surgery [ Time Frame: Day 1 ]
  • laparoscopic surgery-cases annually [ Time Frame: Day 0 ]
  • Basic features of airway pressures (plateauP, peakP, pulmonary Compliance) [ Time Frame: During surgery ]
  • Spontaneous / coughing movements. [ Time Frame: During surgery ]
  • Postoperative pain (area under VAS,opioid rescue,referred pain to the shoulder) [ Time Frame: In the first 24 hours after surgery ]
  • Surgical stress and inflammatory markers (neutrophil/lymphocyte ratio, C-reactive protein,interleukin-6 and procalcitonin). [ Time Frame: In the first 24 hours after surgery ]
  • Selected complications (scale of Clavier-Dindo). [ Time Frame: During surgery ]
  • Inpatient days. [ Time Frame: Day 4 ]
  • Intra-abdominal pressure (IAP) [ Time Frame: During surgery ]
  • Intra-abdominal pressure (IAP) [ Time Frame: Day 1 ]
  • Intra-abdominal pressure (IAP) [ Time Frame: Day 3 ]
  • Intra-abdominal pressure with volume 0 (PV0) [ Time Frame: During surgery ]
  • Intra-abdominal pressure with volume 0 (PV0) [ Time Frame: Day 1 ]
  • Intra-abdominal pressure with volume 0 (PV0) [ Time Frame: Day 3 ]
  • Intra-abdominal pressure (IAP) max [ Time Frame: During surgery ]
  • Intra-abdominal pressure (IAP) max [ Time Frame: Day 1 ]
  • Intra-abdominal pressure (IAP) max [ Time Frame: Day 3 ]
  • Years of Surgeon experience in laparoscopic surgery [ Time Frame: Day 0 ]
  • Dynamic compliance (Vt / Peak Pressure (P1)) [ Time Frame: During surgery ]
    Dynamic compliance is determinated using the airway pressure peak. Dynamic Compliance = Vt / Peak Pressure (P1)


Original Secondary Outcome: Same as current

Information By: Instituto de Investigacion Sanitaria La Fe

Dates:
Date Received: May 2, 2016
Date Started: January 25, 2017
Date Completion: October 2019
Last Updated: April 20, 2017
Last Verified: April 2017