Direct Trocar Versus Verres Needle Entry at Gynecologic Laparoscopy in Previous Scarred Abdomen: A Randomised Clinical Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Laparoscopy
• Intervention / Treatment: Procedure: Direct Trocar; Procedure: Veress Needle Entry

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• previous abdominal and pelvic surgeries
• patients age > 19 years

Exclusion Criteria:

• Massive bowel distension
• BMI >35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct Trocar group	Procedure: Direct Trocar; 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
Active Comparator: Verres Needle Entry	Procedure: Veress Needle Entry; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total operative time	total length of the procedure/total operative time (in minutes)	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Direct Trocar Versus Vs Needle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No