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Completed

NCT Number: NCT03000465

Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

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).

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Key information

Conditions

Individualized Pneumoperitoneum Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years of age
  • ASA I-III (American Society of Anesthesiologists physical status classification)
  • Signed informed consent
  • Absence of cognitive deficit

Exclusion criteria

  • Urgent surgery
  • Pregnancy or breastfeeding
  • Immune Disorder
  • Advanced renal, hepatic or cardiopulmonary disease
  • Negative to participate in the study
  • Under 18 years
  • Inability to give consent
  • Associated neuromuscular disorders
  • Allergy to rocuronium/sugammadex
  • Contraindication for use of rocuronium/sugammadex

Treatment and study plan

Laparoscopic colorectal surgery

Procedure

Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy

Primary outcomes

  1. 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].

Secondary outcomes

  1. 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].

  2. 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].

  3. 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]).

  4. 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.

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Collaborators

  • Instituto de Investigacion Sanitaria La Fe

Registry information

Official study title

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

Acronym: IPPCollapseI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2016
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.