Clinical trial NCT06132490: Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery
Official title: Comparison of the Perioperative Effects of Intra-abdominal Pressure Created With Standard and Valveless Insufflators in Robotic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Hemodynamic Instability
Hypercapnia
Complication,Postoperative
Intraoperative Complications
Keywords: robotic surgery
intra-abdominal pressure
insufflator
postoperative pain
postoperative complications
intraoperative complications
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of manipulations done by the attending anesthesiologists
timeFrame: Intraoperative
Secondary outcomes:
measure: Arterial blood gas lactate levels
timeFrame: Intraoperative
measure: Peak airway pressures
timeFrame: Intraoperative
measure: Mean airway pressures
timeFrame: Intraoperative
measure: Lung compliance
timeFrame: Intraoperative
measure: End tidal carbon dioxide levels
timeFrame: Intraoperative
measure: Minute ventilation
timeFrame: Intraoperative
measure: Systolic blood pressure
timeFrame: Intraoperative
measure: Diastolic blood pressure
timeFrame: Intraoperative
measure: Mean blood pressure
timeFrame: Intraoperative
measure: Heart rate
timeFrame: Intraoperative
measure: Acute Postoperative Pain
timeFrame: Postoperative 24 hours
measure: Postoperative morphine consumption
timeFrame: Postoperative 24 hours
measure: Anesthesia time and operative time
timeFrame: Intraoperative
measure: Intraoperative bleeding
timeFrame: Intraoperative
measure: Urine output
timeFrame: Intraoperative and daily untill discharge
measure: Creatinine levels
timeFrame: Preoperative and postoperative (up to one month)
measure: Hemoglobin levels
timeFrame: Intraoperative and daily untill discharge
measure: Need for blood product transfusion
timeFrame: Intraoperative and daily untill discharge
measure: Number of participants with pulmonary complications
timeFrame: Postoperative, up to one month
measure: Flatus time
timeFrame: Postoperative one week
measure: Time to oral intake
timeFrame: Postoperative 3 days
measure: Number of participants with subcutaneous emphysema
timeFrame: Postoperative, up to one month
measure: Length of hospital stay
timeFrame: Postoperative, up to one month
measure: The Clavien-Dindo classification of surgical complications
timeFrame: Postoperative, up to one month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.