Laparoscopic Entry TechniqueNCT06645392
COMPARATIVE STUDY BETWEEN TERNAMIAN BLADELESS TROCAR ENTRY and VISUAL TRANSPARENT BLADED TROCAR ENTRY in LAPAROSCOPIC PROCEDURES
An observational study of Laparoscopic Entry Technique, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Laparoscopic Entry Technique
- What is being tested?
- visual transparent bladed trocar of and Ternamian bladeless trocar
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Nov 2022
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Al Ainy Teaching Hospital, Cairo University
Giza, Giza Governorate, 22387
About this study
Official title: COMPARATIVE STUDY BETWEEN TERNAMIAN BLADELESS TROCAR ENTRY and VISUAL TRANSPARENT BLADED TROCAR ENTRY in LAPAROSCOPIC PROCEDURES; a PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
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.
Read the 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
- Being tested
- visual transparent bladed trocar of, Ternamian bladeless trocar
- Keywords
- Visual - Transparent - Bladed-Bladeless - Ternamian - trocar laparoscopy).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual transparent bladed trocar ofDevice
visual transparent bladed trocar of diameter 10 mm and Ternamian bladeless trocar of diameter 10 mm
Ternamian bladeless trocarDevice
Ternamian bladeless trocar of diameter 10 mm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Ternamian bladeless trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Entry complications
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Entry TechniqueStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645392
- Sponsor's protocol ID
- LAPAROSCOPIC TROCARS
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Laparoscopic primary entry: visual transparent bladed trocar entry vs Ternamian bladeless trocar entry
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE STUDY BETWEEN TERNAMIAN BLADELESS TROCAR ENTRY and VISUAL TRANSPARENT BLADED TROCAR ENTRY in LAPAROSCOPIC PROCEDURES; a PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT06645392
- Acronym / sponsor ID
- LAPAROSCOPIC TROCARS
- Conditions
- Laparoscopic Entry Technique
- Keywords
- Visual - Transparent - Bladed-Bladeless - Ternamian - trocar laparoscopy).
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, (Visual transparent bladed trocar group) | – | Device: visual transparent bladed trocar ofvisual 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 |
| Group B ( Ternamian bladeless trocar group) | – | Device: Ternamian bladeless trocarTernamian 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual transparent bladed trocar ofvisual transparent bladed trocar of diameter 10 mm and Ternamian bladeless trocar of diameter 10 mm | Device | Group A, (Visual transparent bladed trocar group) |
| Ternamian bladeless trocarTernamian bladeless trocar of diameter 10 mm | Device | Group B ( Ternamian bladeless trocar group) |
Primary outcome
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.
1 secondary outcome
Entry complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: Yes. Laparoscopic primary entry: visual transparent bladed trocar entry vs Ternamian bladeless trocar entry
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Entry Technique, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laparoscopic entry time (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.