NCT06132490

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Koç University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-07-15
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2023-11-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: Turkey (Türkiye)