Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

Study Overview
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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.

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

Conditions
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Individualized Pneumoperitoneum Pressure

Intervention / Treatment
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* Procedure: Laparoscopic colorectal surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients undergoing laparoscopic colorectal surgery | Procedure: Laparoscopic colorectal surgery<br>* Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumoperitoneum pressure, laparoscopic pressure, intra-abdominal insufflation, intra-abdominal pressures, abdominal compliance