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Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

NCT ID: NCT03000465

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Individualized Pneumoperitoneum Pressure

Keywords

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pneumoperitoneum pressure laparoscopic pressure intra-abdominal insufflation intra-abdominal pressures abdominal compliance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients undergoing laparoscopic colorectal surgery

Laparoscopic colorectal surgery

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic colorectal surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role lead

Responsible Party

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Oscar Diaz-Cambronero

Physician, specialist in Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oscar Diaz Cambronero

Role: PRINCIPAL_INVESTIGATOR

Physician, Specialist in Anesthesiology

References

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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.

Reference Type DERIVED
PMID: 29951750 (View on PubMed)

Other Identifiers

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2015/0094

Identifier Type: -

Identifier Source: org_study_id