Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery (IPPCollapseI)

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

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).

Study Overview

• Status: Completed
• Conditions: Individualized Pneumoperitoneum Pressure
• Intervention / Treatment: Procedure: Laparoscopic colorectal surgery

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.

• Study Type: Observational
• Enrollment (Actual): 92

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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,

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients undergoing laparoscopic colorectal surgery	Procedure: Laparoscopic colorectal surgery; Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe
• Collaborators: Instituto de Investigacion Sanitaria La Fe
• Investigators: Principal Investigator: Oscar Diaz Cambronero, Physician, Specialist in Anesthesiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 22, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: pneumoperitoneum pressure; laparoscopic pressure; intra-abdominal insufflation; intra-abdominal pressures; abdominal compliance
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: 2015/0094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED