Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

Completed

• Conditions: Individualized Pneumoperitoneum Pressure
• Interventions: Procedure: Laparoscopic colorectal surgery

• Registration Number: NCT03000465
• Lead Sponsor: Hospital Universitario La Fe

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Study First Posted: 2016-12-22
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Laparoscopic colorectal surgery	Patients undergoing laparoscopic colorectal surgery

Primary Outcome Measures

Name	Time	Method
Minimal intra-abdominal pressure	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 Outcome Measures

Name	Time	Method
Ventilation pattern pressure	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) \[mmH2O\].
Hospital stay	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
Intra-abdominal pressures (Pv0, maximal IAP)	From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.	Pv0 (IAP with volume 0) and maximal IAP \[mmHg\].
Surgeon skills and experience	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.
Intra-abdominal pressures (abdominal compliance).	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 \[L/mmHg\]).
Duration of surgery	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.
Postoperative complications	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.