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

NCT06645392 | Completed DMC

• 1 other identifier: LAPAROSCOPIC TROCARS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Entry Technique

Keywords

Visual - Transparent - Bladed-Bladeless - Ternamian - trocar laparoscopy).

Outcome Measures

Primary Outcomes (1)

• laparoscopic entry time

  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.

  6 months

Secondary Outcomes (1)

• Entry complications

  6 months

Study Arms (2)

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

Device: visual transparent bladed trocar of

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.

Device: Ternamian bladeless trocar

Interventions

visual transparent bladed trocar of DEVICE

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

Group A, (Visual transparent bladed trocar group)

Ternamian bladeless trocar DEVICE

Ternamian bladeless trocar of diameter 10 mm

Group B ( Ternamian bladeless trocar group)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy Teaching Hospital, Cairo University

Giza, Giza Governorate, 22387, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marwa Abdalla

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from now forever
• Access Criteria: everyone

Locations

EG (1)