Gynecologic LaparoscopyNCT07473934
Direct Trocar Versus Verres Needle Entry at Gynecologic Laparoscopy in Previous Scarred Abdomen: A Randomised Clinical Trial
A study testing Veress Needle Entry and Direct Trocar in people with Gynecologic Laparoscopy, run by Assiut University.
Trial summary
Laparoscopy is a minimally invasive technique employed for diagnostic and surgical approaches. Minimally invasive technique compared to laparotomy offer the advantages such as reduced hospital stay, lower morbidity, reduced pain, and faster recovery(1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Laparoscopy
- What is being tested?
- Veress Needle Entry and Direct Trocar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- previous abdominal and pelvic surgeries
- patients age > 19 years
Who cannot join
- Massive bowel distension
- BMI >35
About this study
Laparoscopy is a minimally invasive technique employed for diagnostic and surgical approaches. Minimally invasive technique compared to laparotomy offer the advantages such as reduced hospital stay, lower morbidity, reduced pain, and faster recovery(1). It has become the primary approach for diagnosing and treating gynecological diseases, favored for both benign and malignant conditions involving the uterus, ovaries, and fallopian tubes, as well as for diagnostic evaluations in cases like chronic pelvic pain and infertility (2).
Access to the abdomen is the main challenge of laparoscopic surgery. To minimize entry-related injuries like, subcutaneous emphysema, gastrointestinal tract perforation, and minor and major vascular injury for creation of pneumoperitoneum. Several techniques, instruments, and approaches have been introduced. Despite widespread awareness of laparoscopic entry guidelines, considerable variation in the techniques was adopted in clinical practice(3) However, the initial step of accessing the abdominal cavity presents inherent challenges, especially in patients with previous cesarean sections, whose abdominal anatomy may be altered by adhesions or scar tissue(4).
Read more
Several methods are used for laparoscopic entry. The most common techniques include Veress needle insertion (VNI), direct optical trocar entry, direct trocar insertion (DTI), and the Hasson technique(5).
VNI is the most common method that is used nowadays despite its slow insufflation rates and fatal complications .Veress needle can be introduced periumbilical or in the left hypochondrium. The Palmer's point is a favoured option for periumbilical Veress needle insertion. The point is located 3 cm below the left costal border at the mid-clavicular line. Many studies have found that there are safer and more effective alternate procedures for peritoneal access in patients following abdominal surgery(6).
The DTI technique requires the advancing of the trocar with a blind twisting motion into the peritoneum after the elevation of the anterior abdominal wall with one hand or with towel clamps. If visual inspection with the camera confirms proper placement, pneumoperitoneum is established with the insufflation of a gas. VN requires the insertion and retraction of a spring-loaded needle with an external diameter of 2 mm. When the tip of the needle penetrates through tissues and enters the peritoneal cavity, the inner stylet springs forward. Then, carbon dioxide is insufflated creating a pneumoperitoneum(7).
- Conditions
- Gynecologic Laparoscopy
- Being tested
- Veress Needle Entry, Direct Trocar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veress Needle EntryProcedure or surgery
a stab incision will be made on the selected site for entry (usually transumbilical or umbilical superior crease). The lifting of the abdominal wall will be performed with the non-dominant hand in all cases. The reusable Veress needle fortified with "spring-loaded obturator" will be introduced intraperitoneally at an angle of approximately 90º by the surgeon holding the needle like a dart. The double-click safety test will be employed to verify the precise intraperitoneal location for the needle. This will be followed by attachment of the gas tube to the Veress needle for gas insufflation. Once satisfactory pneumoperitoneum will be realized, the Veress needle will be detached with the subsequent extension of the stab incision to 11 mm incision. The sharp pointed reusable Trocar/cannula will be inserted by rotary movement as described above.
Direct TrocarProcedure or surgery
patient's abdominal wall before the insertion, a transverse or vertical umbilical incision of 1-1.5cm with the scalpel will be made to easily accommodate the first trocar.
The trocar will be inserted until it came into contact with the muscular fascia at an angle of 90o. Subsequently, the abdominal wall will be elevated, caudal to the umbilical scar, creating a tent between the parietal peritoneum and the intracavitary structures.
The anterior abdominal wall will be adequately elevated by hand, and the trocar will be inserted directly into the abdominal cavity, aiming towards the pelvic hollow.
The trocar will be gently inserted into the abdominal cavity at an angle of 45o towards the pelvis, until the click of the security system will be perceived. This indicates the retraction of the blade secondary to the pressure change produced by its entry. There is hissing sound of air gushing in peritoneal cavity will be heard and as air entered the cavity all content fall from the ab
| Study group | Role | What they receive |
|---|---|---|
| Direct Trocar group | Active comparator | Not described Receives: Procedure: Direct Trocar |
| Verres Needle Entry | Active comparator | Not described Receives: Procedure: Veress Needle Entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
total operative time
total length of the procedure/total operative time (in minutes)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic LaparoscopyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedek Ahmed Sedek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473934
- Sponsor's protocol ID
- Direct Trocar Versus Vs Needle
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Trocar Versus Verres Needle Entry at Gynecologic Laparoscopy in Previous Scarred Abdomen: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07473934
- Acronym / sponsor ID
- Direct Trocar Versus Vs Needle
- Conditions
- Gynecologic Laparoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
Laparoscopy is a minimally invasive technique employed for diagnostic and surgical approaches. Minimally invasive technique compared to laparotomy offer the advantages such as reduced hospital stay, lower morbidity, reduced pain, and faster recovery(1). It has become the primary approach for diagnosing and treating gynecological diseases, favored for both benign and malignant conditions involving the uterus, ovaries, and fallopian tubes, as well as for diagnostic evaluations in cases like chronic pelvic pain and infertility (2).
Access to the abdomen is the main challenge of laparoscopic surgery. To minimize entry-related injuries like, subcutaneous emphysema, gastrointestinal tract perforation, and minor and major vascular injury for creation of pneumoperitoneum. Several techniques, instruments, and approaches have been introduced. Despite widespread awareness of laparoscopic entry guidelines, considerable variation in the techniques was adopted in clinical practice(3) However, the initial step of accessing the abdominal cavity presents inherent challenges, especially in patients with previous cesarean sections, whose abdominal anatomy may be altered by adhesions or scar tissue(4).
Several methods are used for laparoscopic entry. The most common techniques include Veress needle insertion (VNI), direct optical trocar entry, direct trocar insertion (DTI), and the Hasson technique(5).
VNI is the most common method that is used nowadays despite its slow insufflation rates and fatal complications .Veress needle can be introduced periumbilical or in the left hypochondrium. The Palmer's point is a favoured option for periumbilical Veress needle insertion. The point is located 3 cm below the left costal border at the mid-clavicular line. Many studies have found that there are safer and more effective alternate procedures for peritoneal access in patients following abdominal surgery(6).
The DTI technique requires the advancing of the trocar with a blind twisting motion into the peritoneum after the elevation of the anterior abdominal wall with one hand or with towel clamps. If visual inspection with the camera confirms proper placement, pneumoperitoneum is established with the insufflation of a gas. VN requires the insertion and retraction of a spring-loaded needle with an external diameter of 2 mm. When the tip of the needle penetrates through tissues and enters the peritoneal cavity, the inner stylet springs forward. Then, carbon dioxide is insufflated creating a pneumoperitoneum(7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Trocar group | Active comparator | Procedure: Direct Trocar |
| Verres Needle Entry | Active comparator | Procedure: Veress Needle Entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- previous abdominal and pelvic surgeries
- patients age > 19 years
Key exclusion criteria (2 listed)
- Massive bowel distension
- BMI >35
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 |
|---|---|---|
| Veress Needle Entrya stab incision will be made on the selected site for entry (usually transumbilical or umbilical superior crease). The lifting of the abdominal wall will be performed with the non-dominant hand in all cases. The reusable Veress needle fortified with "spring-loaded obturator" will be introduced intraperitoneally at an angle of approximately 90º by the surgeon holding the needle like a dart. The double-click safety test will be employed to verify the precise intraperitoneal location for the needle. This will be followed by attachment of the gas tube to the Veress needle for gas insufflation. Once satisfactory pneumoperitoneum will be realized, the Veress needle will be detached with the subsequent extension of the stab incision to 11 mm incision. The sharp pointed reusable Trocar/cannula will be inserted by rotary movement as described above. | Procedure or surgery | Verres Needle Entry |
| Direct Trocarpatient's abdominal wall before the insertion, a transverse or vertical umbilical incision of 1-1.5cm with the scalpel will be made to easily accommodate the first trocar. The trocar will be inserted until it came into contact with the muscular fascia at an angle of 90o. Subsequently, the abdominal wall will be elevated, caudal to the umbilical scar, creating a tent between the parietal peritoneum and the intracavitary structures. The anterior abdominal wall will be adequately elevated by hand, and the trocar will be inserted directly into the abdominal cavity, aiming towards the pelvic hollow. The trocar will be gently inserted into the abdominal cavity at an angle of 45o towards the pelvis, until the click of the security system will be perceived. This indicates the retraction of the blade secondary to the pressure change produced by its entry. There is hissing sound of air gushing in peritoneal cavity will be heard and as air entered the cavity all content fall from the ab | Procedure or surgery | Direct Trocar group |
Primary outcome
total operative time
Time frame: baseline
total length of the procedure/total operative time (in minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Veress Needle Entry and Direct Trocar in people with Gynecologic Laparoscopy, run by Assiut University.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
total operative time (time frame: baseline). 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 Mar 2026.