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

NCT ID: NCT06645392

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-11-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A, (Visual transparent bladed trocar group)

visual transparent bladed trocar of diameter 10 mm is used for abdominal entry; the assistant holds the laparoscope mounted in the cannula of the trocar, and the surgeon lowers the unit (laparoscope and mounted cannula) deep into the umbilical wound where the surgeon uses the muscles of the dominant wrist to rotate the cannula clockwise while keeping the forearm horizontal the patient's abdomen. Downwards axial pressure during rotation is kept to a minimum. Rotation serves to lift the anterior abdominal wall and transpose successive tissue layers onto the cannula's outer thread. The white anterior rectus fascia, red rectus fascia, pearly white posterior rectus fascia, yellowish preperitoneal space, and transparent greyish peritoneal membrane are all observed sequentially on the monitor. Further clockwise rotation parts the peritoneal membrane radially to advance the cannula incrementally into the peritoneal cavity under direct visual control while avoiding cannula overshot

visual transparent bladed trocar of

Intervention Type: DEVICE

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

Group B ( Ternamian bladeless trocar group)

Ternamian bladeless trocar of diameter 10 mm is used for abdominal entry; this trocar is hollow in which a laparoscope is loaded for the distal crystal tip to transmit real-time monitor images while transecting abdominal wall tissue layers. The assistant holds the laparoscope during entry allowing the wrist to move freely while the surgeon applies significant axial thrust through the dominant upper body muscles while twisting the handle to advance the trocar tip and dissect successive tissue layers on its way towards the abdomen. A considerable axial force is applied by the surgeon for the retention of the push-through trocar design with no mechanism to offset overshoot.

Ternamian bladeless trocar

Intervention Type: DEVICE

Ternamian bladeless trocar of diameter 10 mm

Interventions

visual transparent bladed trocar of

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

Intervention Type: DEVICE

Ternamian bladeless trocar

Ternamian bladeless trocar of diameter 10 mm

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohamed Abdalla

Dr. Marwa Abdalla

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Al Ainy Teaching Hospital, Cairo University

Giza, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

LAPAROSCOPIC TROCARS

Identifier Type: -

Identifier Source: org_study_id