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Completed

NCT Number: NCT06645392

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Kasr Al Ainy Teaching Hospital, Cairo University

Giza, Giza Governorate, 22387, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • included patients aged from 20 to 50 years old with uterine and/or adnexal benign lesions, infertility, or chronic pelvic pain indicated for diagnostic and/or therapeutic intervention, and with a body mass index (BMI) less than 40.

Exclusion criteria

  • included patients who have had a history suggestive of pelvic adhesions as previous 4 or more laparotomies, a history of bleeding tendency, and patients with suspected pelvic malignancies.

Treatment and study plan

visual transparent bladed trocar of

Device

visual transparent bladed trocar of diameter 10 mm and Ternamian bladeless trocar of diameter 10 mm

Ternamian bladeless trocar

Device

Ternamian bladeless trocar of diameter 10 mm

Primary outcomes

  1. laparoscopic entry time

    Time frame: 6 months

    Time of entry was accurately estimated in both groups 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.

Secondary outcomes

  1. Entry complications

    Time frame: 6 months

    Complications including major vessel injury or visceral injury that may be encountered during laparoscopic entry could be immediately detected in both groups through the transmitted in time monitor images.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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