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

Overview

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).

Interventions

• 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
• 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

Primary outcome measures

• total operative time [Time frame: baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Massive bowel distension
• BMI >35

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07473934 · Direct Trocar Versus Vs Needle

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗