Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06132490
• Other study ID #: 2022.094.IRB1.040
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Koç University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Peak airway pressures	Peak airway pressures (cmH2O) will be compared among the groups	Intraoperative
Secondary	Mean airway pressures	Mean airway pressures (cmH2O) will be compared among the groups	Intraoperative
Secondary	Lung compliance	Lung compliance (mL/cmH2O) will be compared among the groups	Intraoperative
Secondary	End tidal carbon dioxide levels	End tidal carbon dioxide levels (mmHg) will be compared among the groups	Intraoperative
Secondary	Minute ventilation	Minute ventilation (L/minute) will be compared among the groups	Intraoperative
Secondary	Systolic blood pressure	Systolic arterial pressures (mmHg) will be compared among the groups.	Intraoperative
Secondary	Diastolic blood pressure	Diastolic arterial pressures (mmHg) will be compared among the groups.	Intraoperative
Secondary	Mean blood pressure	Mean arterial pressures (mmHg) will be compared among the groups.	Intraoperative
Secondary	Heart rate	Heart rate (beat per minute) will be compared among the groups	Intraoperative
Secondary	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
Secondary	Postoperative morphine consumption	Intravenous morphine consumption (mg) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours	Postoperative 24 hours
Secondary	Anesthesia time and operative time	Anesthesia and operative times wil be recorded as minutes	Intraoperative
Secondary	Intraoperative bleeding	Total bleeding level estimated by the surgical nurse will be recorded as milliliters at the end of the surgery	Intraoperative
Secondary	Urine output	Kidney function will be monitored by using intraoperative and daily postoperative urine output (mL)	Intraoperative and daily untill discharge
Secondary	Creatinine levels	Kidney function will be monitored by using daily creatinine levels (mg/dL)	Preoperative and postoperative (up to one month)
Secondary	Hemoglobin levels	Intraoperative and daily postoperative hemoglobin levels will be recorded	Intraoperative and daily untill discharge
Secondary	Need for blood product transfusion	Blood product transfusions will be recorded	Intraoperative and daily untill discharge
Secondary	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
Secondary	Flatus time	Postoperative time to first flatus will be recorded	Postoperative one week
Secondary	Time to oral intake	Postoperative time to oral intake will be recorded	Postoperative 3 days
Secondary	Number of participants with subcutaneous emphysema	Subcutaneous emphysema diagnosed with chest radiograph will be recorded	Postoperative, up to one month
Secondary	Length of hospital stay	Length of hospital stay will be recorded as hours	Postoperative, up to one month
Secondary	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