Clinical Trial: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: Optimizing all factors that increase the intra-abdominal volume and performing an individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15 mmHg).

Detailed Summary:

In the context of multimodal rehabilitation in colorectal laparoscopic surgery (Fast Track or ERAS (Enhance Recovery After Surgery)) multiple strategies have been introduced that have managed to improve patient recovery, decrease postoperative complications, decrease hospital days and decrease the overall costs per process.

The possibility of performing individualized colorectal laparoscopic surgery with the minimum insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and this would allow us to reduce the impact of surgery on the patient, decrease perioperative morbidity and improve patient recovery.

In our study, abdominal compliance, Pv0 and maximal Pv were determined during the initial performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of intra-abdominal pressure (IAP) insufflation was stablished with evaluation by the surgeons, until reaching the minimal insufflation IAP in which optimal surgical conditions are maintained.


Sponsor: Hospital Universitario La Fe

Current Primary Outcome: Minimal intra-abdominal pressure [ Time Frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes. ]

To obtain values of intra-abdominal pressure level of minimum insufflation that guarantees optimal surgical conditions following an individualized strategy [mmHg].


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ventilation pattern pressure [ Time Frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes. ]
    Airway pressures at different levels of IAP (peak pressure, PEEP (positive end expiratory pressure), plateau pressure, driving pressure) [mmH2O].
  • Intra-abdominal pressures (Pv0, maximal IAP) [ Time Frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes. ]
    Pv0 (IAP with volume 0) and maximal IAP [mmHg].
  • Intra-abdominal pressures (abdominal compliance). [ Time Frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes. ]
    Dynamic abdominal compliance per liter (DV/DP, difference in volume/difference in pressure [L/mmHg]).
  • Surgeon skills and experience [ Time Frame: Years of experience, up to 10 years. ]
    Previous experience of the surgeon in laparoscopic surgery, annual cases, years of experience, previous experience with low IAP.
  • Duration of surgery [ Time Frame: The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes. ]
    Duration of surgery in minutes from incision to abdominal wall closure.
  • Postoperative complications [ Time Frame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days. ]
    Evolution and complications in the postoperative period: Postoperative pain in the first 24 hours. Postoperative complications were assessed using the Clavier-Dindo classification.
  • Hospital stay [ Time Frame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days. ]
    Hospital stay in days


Original Secondary Outcome: Same as current

Information By: Hospital Universitario La Fe

Dates:
Date Received: December 15, 2016
Date Started: May 2015
Date Completion:
Last Updated: December 19, 2016
Last Verified: December 2016