Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

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

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2023-12-30

Brief Summary

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The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.

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Detailed Description

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Adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. Patients will be randomized in three groups. In group I, conventional insufflators will be used with 12 mmHg intra-abdominal pressure; in group II, valveless insufflators will be used with 12 mmHg intra-abdominal pressure and in group III, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. Each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (PCA). Postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. Patient length of stay, time to first flatus, urine output, postoperative complications(graded by Clavien Dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.

Conditions

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Post Operative Pain Hemodynamic Instability Hypercapnia Complication,Postoperative Intraoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

The patient and the pain nurses will be blind to the intervention due to the study design.

Study Groups

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Valveless 12

Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure.

Group Type EXPERIMENTAL

Valveless Insufflator with 12 mmHg intra-abdominal pressure

Intervention Type DEVICE

In this group valveless insufflators, which are relatively new in clinical practice, will be used under low intra-abdominal pressure throughout the surgery.

Valveless 8

Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure.

Group Type EXPERIMENTAL

Valveless Insufflator with 8 mmHg intra-abdominal pressure

Intervention Type DEVICE

In this group valveless insufflators, which are relatively new in clinical practice, will be used under ultra-low intra-abdominal pressure throughout the surgery.

Interventions

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Valveless Insufflator with 12 mmHg intra-abdominal pressure

In this group valveless insufflators, which are relatively new in clinical practice, will be used under low intra-abdominal pressure throughout the surgery.

Intervention Type DEVICE

Valveless Insufflator with 8 mmHg intra-abdominal pressure

In this group valveless insufflators, which are relatively new in clinical practice, will be used under ultra-low intra-abdominal pressure throughout the surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.)
* ASA (American Society of Anesthesiologists) Physical Status I-II-III

Exclusion Criteria

* Patients without consent
* Emergency surgery
* Bleeding diathesis
* Pregnancy or lactation
* Prior history of major abdominal/pelvic surgery
* Chronic kidney disease
* Chronic opioid consumption for chronic pain
* Inability to communicate with the patient due to language barriers or mental status

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No