Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

NCT06132490 | Completed

• 1 other identifier: 2022.094.IRB1.040
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain; Hemodynamic Instability; Hypercapnia; Complication,Postoperative; Intraoperative Complications

Keywords

robotic surgery; intra-abdominal pressure; insufflator; postoperative pain; postoperative complications; intraoperative complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Arterial blood gas lactate levels

  Intraoperative

• Peak airway pressures

  Intraoperative

• Mean airway pressures

  Intraoperative

• Lung compliance

  Intraoperative

• End tidal carbon dioxide levels

  Intraoperative

Study Arms (2)

Valveless 12

EXPERIMENTAL

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

Valveless 8

EXPERIMENTAL

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

Interventions

Valveless Insufflator with 12 mmHg intra-abdominal pressure 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 12

Valveless Insufflator with 8 mmHg intra-abdominal pressure 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.

Valveless 8

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32632561 BACKGROUND

• 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.

  PMID: 23186377 BACKGROUND

• 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.

  PMID: 32333365 BACKGROUND

• 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.

  PMID: 28669704 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Hypercapnia; Postoperative Complications; Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient and the pain nurses will be blind to the intervention due to the study design.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: November 15, 2023
• Study Start: July 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 15, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after the publication
• Access Criteria: Academic purposes

Locations

TU (1)