Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

NCT03000465 | Completed

• 1 other identifier: 2015/0094
• Study Type: observational
• Target: 92
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Individualized Pneumoperitoneum Pressure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Minimal intra-abdominal pressure

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

  From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.

Secondary Outcomes (7)

• Ventilation pattern pressure

  From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.

• Intra-abdominal pressures (Pv0, maximal IAP)

  From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.

• Intra-abdominal pressures (abdominal compliance).

  From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.

• Surgeon skills and experience

  Years of experience, up to 10 years.

• Duration of surgery

  The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes.

Study Arms (1)

Patients

Patients undergoing laparoscopic colorectal surgery

Procedure: Laparoscopic colorectal surgery

Interventions

Laparoscopic colorectal surgery PROCEDURE

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead
• Instituto de Investigacion Sanitaria La Fe: collaborator

Related Publications (1)

• 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.

  PMID: 29951750 DERIVED

Study Officials

• Oscar Diaz Cambronero

  Physician, Specialist in Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, specialist in Anesthesiology

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 22, 2016
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12