Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

Comparison of the Perioperative Effects of Intra-abdominal Pressure Created With Standard and Valveless Insufflators in Robotic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Complications; Complication,Postoperative; Post Operative Pain; Hypercapnia; Hemodynamic Instability
• Intervention / Treatment: Device: Valveless Insufflator with 12 mmHg intra-abdominal pressure; Device: Valveless Insufflator with 8 mmHg intra-abdominal pressure

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34010
    • Koc University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valveless 12; Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure.	Device: 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.
Experimental: Valveless 8; Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of manipulations done by the attending anesthesiologists	After the induction of general anesthesia, orotracheal intubation and arterial catheterization; a standard ventilation and anesthesia maintenance strategy will be applied. Every manipulation performed to keep the parameters monitored by the anesthesiologists within physiological limits will be recorded: ventilation frequency setting, remifentail infusion titration, administration of vasoactive agents, etc.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood gas lactate levels	Arterial blood gas will be sampled at standardized times during the operation and lactate levels will be compared among the groups	Intraoperative
Peak airway pressures	Peak airway pressures (cmH2O) will be compared among the groups	Intraoperative
Mean airway pressures	Mean airway pressures (cmH2O) will be compared among the groups	Intraoperative
Lung compliance	Lung compliance (mL/cmH2O) will be compared among the groups	Intraoperative
End tidal carbon dioxide levels	End tidal carbon dioxide levels (mmHg) will be compared among the groups	Intraoperative
Minute ventilation	Minute ventilation (L/minute) will be compared among the groups	Intraoperative
Systolic blood pressure	Systolic arterial pressures (mmHg) will be compared among the groups.	Intraoperative
Diastolic blood pressure	Diastolic arterial pressures (mmHg) will be compared among the groups.	Intraoperative
Mean blood pressure	Mean arterial pressures (mmHg) will be compared among the groups.	Intraoperative
Heart rate	Heart rate (beat per minute) will be compared among the groups	Intraoperative
Acute Postoperative Pain	Acute postoperative pain reported with numeric rating scale (0-10) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours with 0 meaning no pain and 10 meaning worst imaginable pain.	Postoperative 24 hours
Postoperative morphine consumption	Intravenous morphine consumption (mg) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours	Postoperative 24 hours
Anesthesia time and operative time	Anesthesia and operative times wil be recorded as minutes	Intraoperative
Intraoperative bleeding	Total bleeding level estimated by the surgical nurse will be recorded as milliliters at the end of the surgery	Intraoperative
Urine output	Kidney function will be monitored by using intraoperative and daily postoperative urine output (mL)	Intraoperative and daily untill discharge
Creatinine levels	Kidney function will be monitored by using daily creatinine levels (mg/dL)	Preoperative and postoperative (up to one month)
Hemoglobin levels	Intraoperative and daily postoperative hemoglobin levels will be recorded	Intraoperative and daily untill discharge
Need for blood product transfusion	Blood product transfusions will be recorded	Intraoperative and daily untill discharge
Number of participants with pulmonary complications	Pulmonary complications like atelectasis, pulmonary oedema, pleural effusion, pneumothorax, pneumonia, ventilatory failure will be recorded for each patient. And number of patients with pulmonary complications will be compared among the groups.	Postoperative, up to one month
Flatus time	Postoperative time to first flatus will be recorded	Postoperative one week
Time to oral intake	Postoperative time to oral intake will be recorded	Postoperative 3 days
Number of participants with subcutaneous emphysema	Subcutaneous emphysema diagnosed with chest radiograph will be recorded	Postoperative, up to one month
Length of hospital stay	Length of hospital stay will be recorded as hours	Postoperative, up to one month
The Clavien-Dindo classification of surgical complications	Any postoperative complication will be graded by the Clavien-Dindo classification between I to V with I meaning any deviation from the postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions and V meaning death of a patient.	Postoperative, up to one month

Collaborators and Investigators

• Sponsor: Koç University

Publications and helpful links

General Publications

• Feng TS, Heulitt G, Islam A, Porter JR. Comparison of valve-less and standard insufflation on pneumoperitoneum-related complications in robotic partial nephrectomy: a prospective randomized trial. J Robot Surg. 2021 Jun;15(3):381-388. doi: 10.1007/s11701-020-01117-z. Epub 2020 Jul 6.
• Horstmann M, Horton K, Kurz M, Padevit C, John H. Prospective comparison between the AirSeal(R) System valve-less Trocar and a standard Versaport Plus V2 Trocar in robotic-assisted radical prostatectomy. J Endourol. 2013 May;27(5):579-82. doi: 10.1089/end.2012.0632. Epub 2013 Feb 5.
• Paull JO, Parsacandola SA, Graham A, Hota S, Pudalov N, Obias V. The impact of the AirSeal(R) valve-less trocar system in robotic colorectal surgery: a single-surgeon retrospective review. J Robot Surg. 2021 Feb;15(1):87-92. doi: 10.1007/s11701-020-01071-w. Epub 2020 Apr 24.
• La Falce S, Novara G, Gandaglia G, Umari P, De Naeyer G, D'Hondt F, Beresian J, Carette R, Penicka M, Mo Y, Vandenbroucke G, Mottrie A. Low Pressure Robot-assisted Radical Prostatectomy With the AirSeal System at OLV Hospital: Results From a Prospective Study. Clin Genitourin Cancer. 2017 Dec;15(6):e1029-e1037. doi: 10.1016/j.clgc.2017.05.027. Epub 2017 Jun 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: intra-abdominal pressure; postoperative pain; robotic surgery; postoperative complications; intraoperative complications; insufflator
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Respiratory; Pain, Postoperative; Postoperative Complications; Intraoperative Complications; Hypercapnia
• Other Study ID Numbers: 2022.094.IRB1.040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g , meta-analyses) upon request to the corresponding author, and with a signed data access agreement.
• IPD Sharing Time Frame: 6 months after the publication
• IPD Sharing Access Criteria: Academic purposes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No