Clinical trial NCT03000465: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery
Official title: Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-I)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Individualized Pneumoperitoneum Pressure
Keywords: pneumoperitoneum pressure
laparoscopic pressure
intra-abdominal insufflation
intra-abdominal pressures
abdominal compliance
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
Collaborators: name: Instituto de Investigacion Sanitaria La Fe
First posted: 2016-12-22
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing colorectal laparoscopic surgery. Patients will be excluded of the analysis if the surgery cannot be finished by laparoscopy,

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Minimal intra-abdominal pressure
timeFrame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
Secondary outcomes:
measure: Ventilation pattern pressure
timeFrame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
measure: Intra-abdominal pressures (Pv0, maximal IAP)
timeFrame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
measure: Intra-abdominal pressures (abdominal compliance).
timeFrame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
measure: Surgeon skills and experience
timeFrame: Years of experience, up to 10 years.
measure: Duration of surgery
timeFrame: The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes.
measure: Postoperative complications
timeFrame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.
measure: Hospital stay
timeFrame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.
Other outcomes:
Locations:
Study officials:
affiliation: Physician, Specialist in Anesthesiology
name: Oscar Diaz Cambronero
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz-Cambronero O, Flor Lorente B, Mazzinari G, Vila Montanes M, Garcia Gregorio N, Robles Hernandez D, Olmedilla Arnal LE, Argente Navarro MP, Schultz MJ, Errando CL; IPPColLapSe study group. A multifaceted individualized pneumoperitoneum strategy for laparoscopic colorectal surgery: a multicenter observational feasibility study. Surg Endosc. 2019 Jan;33(1):252-260. doi: 10.1007/s00464-018-6305-y. Epub 2018 Jun 27.