Blunt Fascial vs. Veress Needle Entry for Laparoscopic Surgery

(BluntFascial Trial)

Overseen By Kacey Hamilton

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Pregnancy, Urgent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day of surgery

100 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Blunt Fascial vs. Veress Needle Entry for Laparoscopic Surgery is an effective treatment?

The available research shows that both the Blunt Fascial (open) and Veress Needle (closed) techniques for laparoscopic surgery have their own benefits and risks. The study comparing these techniques found that the choice between them should be based on factors like the surgeon's experience and patient-specific details. The Veress Needle technique is associated with a low rate of injuries, but these can be serious if they occur. On the other hand, the open technique is suggested to reduce the risk of major injuries, especially in patients with abdominal scars. Another study introduced a new blunt-tipped tool that might be safer and faster than the Veress Needle, suggesting that alternatives to both traditional methods are being explored for better safety and efficiency. ^{1 2 3 4 5}

What safety data exists for Blunt Fascial vs. Veress Needle Entry in laparoscopic surgery?

The Veress needle technique, commonly used for initiating pneumoperitoneum in laparoscopic surgery, has a low but notable risk of entry-related injuries, such as intestinal and major vascular injuries, occurring in 0.04-0.1% of cases. These injuries can result in mortality rates between 2.5 and 30% if undiagnosed. The open entry technique, although less popular, is considered safer with fewer complications. Studies comparing the two techniques suggest that the choice should be based on factors like patient characteristics and surgeon experience, as the Veress needle is associated with higher rates of complications, including vascular injuries and bowel perforations. Efforts to improve safety include developing devices like the abdominal wall entry suction device and improved Veress needle prototypes. ^{2 4 6 7 8}

Is Blunt fascial abdominal entry, Veress needle abdominal entry a promising treatment?

The Veress needle technique is commonly used in laparoscopic surgery to create space in the abdomen for better visibility. It is a popular choice among surgeons due to its effectiveness in initiating the procedure. However, the choice between the Veress needle and other techniques often depends on the surgeon's experience and preference, as well as patient-specific factors. ^{2 3 4 8 9}

What is the purpose of this trial?

This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected. The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique. Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique. Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique.

Research Team

Raanan Meyer, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults over 18 who are having laparoscopic surgery at Cedars-Sinai Medical Center with a Minimally Invasive Gynecologic Surgery division surgeon. Participants must consent to the study's procedures and be available throughout its duration.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

I am having laparoscopic surgery at Cedars-Sinai with a specialized surgeon.

Exclusion Criteria

I require surgery that cannot be scheduled in advance.

Pregnancy

Non-eligible for umbilical entry

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic gynecologic surgery using either the blunt fascial or Veress needle peritoneal entry technique

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for postoperative complications and pain scores

30 days

Treatment Details

Interventions

• Blunt fascial abdominal entry
• Veress needle abdominal entry

Trial Overview The study compares two methods of starting laparoscopic surgery: blunt fascial and Veress needle abdominal entry. It will measure how long it takes to inflate the abdomen, success rates, complications, and post-surgery pain levels.

Participant Groups

Group I: Blunt fascial entry Experimental Treatment 1 Intervention

The blunt fascial entry technique will be used for patients in this arm

Group II: Veress needle entry technique Active Control 1 Intervention

The Veress needle entry technique will be used for patients in this arm

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

In a study of 330 patients undergoing laparoscopic procedures, the routine use of an open technique for inserting the Veress needle significantly reduced the risk of severe complications, with no major vascular or visceral injuries reported.

Only 3.6% of patients experienced minor postoperative complications, demonstrating that the open technique is a safer alternative to the traditional blind method, especially in patients with abdominal scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine use of open technique in laparoscopic operations. Nuzzo, G., Giuliante, F., Tebala, GD., et al.[2022]

In a study of 365 patients undergoing laparoscopic abdominal surgery, the choice of entry technique (Veress needle vs. open technique) significantly influenced the occurrence of postoperative complications, particularly abdominal pain, which affected 40.5% of patients.

The findings suggest that the selection of the entry technique should be personalized based on individual patient factors and the surgeon's experience, highlighting the importance of tailored approaches in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Veress Needle Versus Open Technique in Abdominal Surgeries. Alhajress, GI., Al Babtain, I., Alsaghyir, A., et al.[2021]

In a study of 95 patients undergoing laparoscopic surgery, using concomitant CO2 insufflation during Veress needle entry resulted in a significantly higher success rate on the first attempt (89%) compared to subsequent insufflation (67%).

The time taken for adequate insufflation was similar between the two techniques, with no serious complications reported, indicating that both methods are safe but that concomitant insufflation may enhance initial entry success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Entry Technique Using a Veress Needle Insertion with and without Concomitant CO2 Insufflation: A Randomized Controlled Trial. Mikhail, E., Tamhane, N., Sarkar, P., et al.[2020]

The novel abdominal wall entry suction device (AWESD) significantly increased the distance between the abdominal wall and critical structures like the intestines, vena cava, and abdominal aorta, which could potentially reduce the risk of entry-related injuries during laparoscopic surgery.

In a pilot study with 12 participants, the AWESD improved safety margins for Veress needle insertion, but further high-volume studies are needed to confirm its clinical effectiveness and safety in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel abdominal wall entry suction device to increase Veress needle safety: A prospective cohort pilot study. Daemen, JHT., Deden, LN., van den Ende, A., et al.[2022]

The new blunt-tipped trocar was successfully used in laparoscopic procedures for 15 patients, allowing for initial access and abdominal cavity insufflation without the need for a Veress needle.

This technique is potentially safer and more time-efficient than traditional methods, as it eliminates the need for fascial sutures to prevent air leaks, which are required with Hasson-type trocars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urologic laparoscopy with a new blunt-tipped trocar: safe, rapid access without the use of fascial sutures. Ohl, DA., Faerber, GJ., Hurd, WW.[2019]

The open entry technique for laparoscopic surgery is associated with fewer complications compared to the closed entry technique, as indicated by 17 out of 31 studies reviewed.

However, most studies supporting the open technique did not meet the highest standards of evidence-based medicine, highlighting the need for more rigorous randomized studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open versus closed laparoscopy entry--which are the evidences? Opilka, M., Starzewski, J., Lorenc, Z., et al.[2009]

The improved Veress needle design, featuring a distal expandable portion, enhances the safety of laparoscopic surgery by allowing safer insertion of the first trocar, with no reported complications or damage during testing on both Gallus domesticus and porcine models.

In tests involving 20 insertions, the new needle demonstrated excellent ease of use and stability, achieving a high average rating of 4.9 out of 5 for performance, indicating it is as effective as the traditional Veress needle without requiring additional training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer trocar insertion for closed laparoscopic access: ex vivo assessment of an improved Veress needle. Nevler, A., Har-Zahav, G., Rosin, D., et al.[2019]

The use of the Veress needle for initial entry in laparoscopic surgery carries risks, including potential injury to retroperitoneal structures like the kidneys, as demonstrated in a case where a patient developed a hematoma and renal injury after surgery.

Surgeons should be vigilant for signs of hemodynamic instability following entry, as this may indicate serious complications, warranting immediate investigation or intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal Hilum Injury with Veress Needle. Nassar, D., Shu, M., Stevens, R., et al.[2023]

In a study of 453 patients undergoing laparoscopic surgery, the modified Open Approach (OA) technique showed no major complications, making it the safest option compared to Direct Trocar (DT) and Veress Needle (VN) techniques, which had some serious complications.

While DT and VN are quicker methods, they are associated with higher risks of major complications, such as colon and iliac artery injuries, highlighting the modified OA as a more reliable choice for laparoscopic entry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of entry using Direct Trocar and/or Veress Needle compared with modified open approach entry in laparoscopy: six-year experience. Shayani-Nasab, H., Amir-Zargar, MA., Mousavi-Bahar, SH., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Routine use of open technique in laparoscopic operations. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Complications of Veress Needle Versus Open Technique in Abdominal Surgeries. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Entry Technique Using a Veress Needle Insertion with and without Concomitant CO2 Insufflation: A Randomized Controlled Trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A novel abdominal wall entry suction device to increase Veress needle safety: A prospective cohort pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Urologic laparoscopy with a new blunt-tipped trocar: safe, rapid access without the use of fascial sutures. [2019]

6. Greece pubmed.ncbi.nlm.nih.gov

Open versus closed laparoscopy entry--which are the evidences? [2009]

7. Germany pubmed.ncbi.nlm.nih.gov

Safer trocar insertion for closed laparoscopic access: ex vivo assessment of an improved Veress needle. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Renal Hilum Injury with Veress Needle. [2023]

9. Iran pubmed.ncbi.nlm.nih.gov

Complications of entry using Direct Trocar and/or Veress Needle compared with modified open approach entry in laparoscopy: six-year experience. [2013]