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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two techniques for initiating laparoscopic surgery, a minimally invasive procedure. The researchers aim to determine if using a blunt instrument for entry (blunt fascial abdominal entry) is as effective as using a Veress needle (Veress needle abdominal entry), focusing on the time to start the surgery and patient recovery. Individuals undergoing regular laparoscopic surgery at Cedars-Sinai with a gynecologic surgeon may qualify. The trial will assess factors such as the speed of surgery initiation and postoperative pain levels. As an unphased trial, it offers patients the chance to contribute to advancements in surgical techniques that could enhance recovery experiences.

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 prior data suggests that these peritoneal entry techniques are safe for laparoscopic surgery?

Research has shown that both the blunt fascial and Veress needle techniques are generally safe for surgeries. Studies indicate that complications with the blunt fascial entry are rare, occurring in about 1.1 to 5.5 out of every 1000 procedures, with very few people experiencing problems. These studies reported no major injuries, such as damage to blood vessels or gas leaks.

For the Veress needle technique, the risk of injury is slightly higher but remains low, with research suggesting injuries occur in about 2 to 3 out of every 1000 procedures.

Overall, while both techniques carry some risks, most patients tolerate them well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial comparing the blunt fascial entry and Veress needle entry techniques for laparoscopic surgery because it could lead to safer, more efficient surgical procedures. The blunt fascial entry method may reduce the risk of injury to internal organs and blood vessels, a concern with the traditional Veress needle technique. Additionally, the blunt approach could potentially offer quicker recovery times and less postoperative pain for patients. Understanding these differences could improve surgical outcomes and refine best practices in minimal access surgery.

What evidence suggests that this trial's entry techniques could be effective for laparoscopic surgery?

This trial will compare the blunt fascial entry technique with the Veress needle entry technique for laparoscopic surgery. Research has shown that both techniques are generally safe. Participants in the blunt fascial entry arm will experience a method known for consistency and a lower risk of injury compared to non-visual methods, with complication rates between 1.1 and 5.5 per 1000 cases. Participants in the Veress needle entry arm will undergo a technique with about an 89% success rate on the first attempt and a low injury rate of around 0.23% to 0.31%. Both methods are considered equally safe and effective, each offering distinct benefits in ease of use and risk of complications. ^{1 3 5 6 7}

Who Is on the Research Team?

Raanan Meyer, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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

Pregnancy

I require surgery that cannot be scheduled in advance.

Non-eligible for umbilical entry

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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 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]

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]

Citations

1. ajog.org ajog.org/article/S0002-9378(24)00305-3/fulltext

The blunt fascial entry technique - a new abdominal access ... Randomized controlled trials indicate the risk of complications is low and comparable between the different access techniques, ranging from 1.1-5.5 per 1000 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06305975

Blunt Fascial vs. Veress Needle Peritoneal Entry in ... This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12539021/

A Novel, Sutureless, Open Laparoscopic Entry Technique This approach is favored for its reproducibility, safety profile, and reduced risk of visceral or vascular injury compared to blind entry ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6353066/

Laparoscopic entry techniques - PMC - PubMed Central Evidence suggests that laparoscopy provides significant benefits compared to laparotomy in terms of surgical outcomes for patients and costs for healthcare ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213307013000981

Principles of safe abdominal entry in laparoscopic ... The open entry technique is associated with a significant reduction of failed entry, compared to the closed entry technique; however there is no difference in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002937824003053

The blunt fascial entry technique - a new abdominal access ... Randomized controlled trials indicate the risk of complications is low and comparable between the different access techniques, ranging from 1.1-5.5 per 1000 ...

7. journal.utripoli.edu.ly journal.utripoli.edu.ly/index.php/Alqalam/article/view/1125

Evaluation of the Safety and Efficacy of the Open Entry ... Results showed no vascular or visceral injuries, and zero incidence of gas leakage. The technique proved effective across surgeon experience ...