An observational study in Laparoscopic Entry Technique, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Cairo University · Observational
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.
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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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.
Exclusion Criteria:
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
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
visual transparent bladed trocar of diameter 10 mm and Ternamian bladeless trocar of diameter 10 mm
Ternamian bladeless trocar of diameter 10 mm
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.
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: Yes — Laparoscopic primary entry: visual transparent bladed trocar entry vs Ternamian bladeless trocar entry
Supporting information: Study protocol
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Cairo University