NCT06645392

COMPARATIVE STUDY BETWEEN TERNAMIAN BLADELESS TROCAR ENTRY and VISUAL TRANSPARENT BLADED TROCAR ENTRY in LAPAROSCOPIC PROCEDURES

COMPARATIVE STUDY BETWEEN TERNAMIAN BLADELESS TROCAR ENTRY and VISUAL TRANSPARENT BLADED TROCAR ENTRY in LAPAROSCOPIC PROCEDURES; a PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety between Ternamian bladeless trocar entry and visual, transparent bladed trocar entry in laparoscopic procedures. A prospective randomized controlled study will be conducted among 100 female patients who will be admitted to the department of Gynecology and Obstetrics at Kasr Alainy university hospital for diagnostic and/or therapeutic laparoscopic intervention. Patients will be randomly assigned (1:1) using computer-generated random numbers to undergo laproscopic entry either by the visual transparent bladed trocar or the Ternamian bladeless trocar. Main outcome measures: entry time of trocar entry in seconds and visceral or major vascular injury during trocar entry.

Detailed description

To compare the efficacy and safety between Ternamian bladeless trocar entry and visual transparent bladed trocar entry in laparoscopic procedures. A prospective randomized controlled study will be conducted among 100 female patients who were admitted to the department of Gynecology and Obstetrics at Kasr Alainy university hospital for diagnostic and/or therapeutic laparoscopic intervention. Patients were randomly assigned (1:1) using computer-generated random numbers to undergo laproscopic entry either by the visual transparent bladed trocar or the Ternamian bladeless trocar. Entry time in seconds starting from the moment the trocar is applied through the umbilical incision to the moment the peritoneal cavity is entered, guided by transmitted images on the monitor, will be used to assess the efficacy of the used trocar type. Complications including major vessel injury or visceral injury that maybe encountered during laparoscopic entry could be immediately detected in both groups through the transmitted in time monitor images to assess safety of the used trocar type. Main outcome measures: entry time of trocar entry in seconds and visceral or major vascular injury during trocar entry.

Conditions

• Laparoscopic Entry Technique

Interventions

Type	Name	Description
DEVICE	visual transparent bladed trocar of	visual transparent bladed trocar of diameter 10 mm and Ternamian bladeless trocar of diameter 10 mm
DEVICE	Ternamian bladeless trocar	Ternamian bladeless trocar of diameter 10 mm

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: Egypt