Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

Individualized Pneumoperitoneum Pressure Clinical Trial

— IPPCollapseI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000465
• Other study ID #: 2015/0094
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 19, 2016
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Individualized Pneumoperitoneum Pressure
• Pneumoperitoneum

Intervention

Procedure:
• Laparoscopic colorectal surgery
Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario La Fe	Instituto de Investigacion Sanitaria La Fe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No