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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2018-11-19

Brief Summary

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The purpose of this study is to assess the post-operative recovery quality of the Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery of their stay in the Post-Anaesthesia Recovery Unit.

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Detailed Description

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In the last two decades laparoscopic surgery has settled as a less invasive surgical approach compared to open surgery. It is associated with lower perioperative morbidity and hospital stay. There is growing evidence that increased intra-abdominal pressure (IAP), even for short periods of time, is associated with increased perioperative morbidity (pain, increased inflammatory markers peritoneal injury worse splanchnic perfusion abnormalities hemodynamic and ventilatory ...).

The study is a prospective multicenter randomized clinical intervention trial to assess the impact of IAP individualization strategy (IPP-Individualized pneumoperitoneum Pressure) relative to a IAP standard strategy (SPP-Standard pneumoperitoneum Pressure) using a validated scale (VAS) (PQRS- Postoperative Quality of Recovery Scale). Postoperative pain in the first 24 hours (area under VAS curve , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/lymphocyte, ratio,C-reactive protein, interleukin-6, procalcitonin) are also measured. Postoperative complications are evaluated by Clavier-Dindo classification.

Conditions

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Colorectal Surgery Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

neuromuscular blocking agents as type of drug

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Individualized Pneumoperitoneum Pressure

In Individualized Pneumoperitoneum Pressure (IPP) group, measures to optimize and individualize intra-abdominal pressure (PIA) will be apply.

Group Type EXPERIMENTAL

IPP in colorectal laparoscopic surgery

Intervention Type PROCEDURE

Deep neuromuscular blockade can only be reversed with sugammadex, so in the IPP group, it will be used as neuromuscular blocking agent and its effect will be reversed with sugammadex (4mg / kg) at the end of the surgery. During surgery: deep neuromuscular blockade (PTC 1-5), Protective ventilation strategy, Optimal position and Pre stretching as a tool to decrease intraabdominal pressure maintaining optimal workspace.

Standard Pneumoperitoneum Pressure

In Standard Pneumoperitoneum Pressure (SPP) group, a conventional operation without optimization measures and PIA preset to 12 mmHg will be conducted.

Group Type OTHER

SPP in colorectal laparoscopic surgery

Intervention Type PROCEDURE

A depolarizing neuromuscular blocking will be used (as routine clinical practice at each center) to maintain moderate neuromuscular blockade and its effect will be reversed with anticholinesterase at the end of the surgery. During surgery: Moderate neuromuscular blockade ( TOF 2-4) , position to surgeon criteria, no prestretching and Protective ventilation. Fixed IAP (12mmHg).

Interventions

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IPP in colorectal laparoscopic surgery

Deep neuromuscular blockade can only be reversed with sugammadex, so in the IPP group, it will be used as neuromuscular blocking agent and its effect will be reversed with sugammadex (4mg / kg) at the end of the surgery. During surgery: deep neuromuscular blockade (PTC 1-5), Protective ventilation strategy, Optimal position and Pre stretching as a tool to decrease intraabdominal pressure maintaining optimal workspace.

Intervention Type PROCEDURE

SPP in colorectal laparoscopic surgery

A depolarizing neuromuscular blocking will be used (as routine clinical practice at each center) to maintain moderate neuromuscular blockade and its effect will be reversed with anticholinesterase at the end of the surgery. During surgery: Moderate neuromuscular blockade ( TOF 2-4) , position to surgeon criteria, no prestretching and Protective ventilation. Fixed IAP (12mmHg).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years
* Classification of the American Society of Anesthesiologists (ASA I-III)
* No cognitive deficits
* Signed informed consent prior to surgery

Exclusion Criteria

* Emergency surgery
* Pregnancy or lactation
* Immune disorders
* Kidney or liver disease or advanced-stage cardiopulmonary
* Patient refusal to participate in the study
* Patients under 18 years or inability to consent
* Associated neuromuscular disorders, contraindication for the use of rocuronium/ sugammadex, allergy or hypersensitivity to rocuronium / sugammadex

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No