Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery

NCT06305975 | Recruiting

• 1 other identifier: STUDY00003169
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Surgery

Keywords

Abdominal entry; Laparoscopy; Insufflation time; Postoperative pain; Safety

Outcome Measures

Primary Outcomes (2)

• Insufflation time

  The time it takes to insufflate the abdominal cavity to 15 mm Hg.

  Intraoperative

• Success upon peritoneal entry

  Successful abdominal entry in the first trial

  Intraoperative

Secondary Outcomes (5)

• Intraoperative complications

  Intraoperative

• Postoperative complications

  Postoperative period within 30 days of surgery

• Patients pain scores

  Day of surgery, postoperatively and before discharge

• Analgesics use

  Day of surgery, postoperatively and before discharge

• Length of hospital stay

  Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day.

Study Arms (2)

Blunt fascial entry

EXPERIMENTAL

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

Procedure: Blunt fascial abdominal entry

Veress needle entry technique

ACTIVE COMPARATOR

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

Procedure: Veress needle abdominal entry

Interventions

Blunt fascial abdominal entry PROCEDURE

Blunt fascial entry technique description: a 5 mm incision is made in the umbilicus. Next, a curved Kelly forceps is used to open the fascia, and, if possible, the peritoneum. The Kelly forceps are then used to expand the opening to a 10 mm diameter. A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.

Blunt fascial entry

Veress needle abdominal entry PROCEDURE

Veress needle abdominal entry technique description: a 5 mm incision is made in the umbilicus. Next, a Veress needle is used to enter the peritoneal cavity and inflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.

Veress needle entry technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• years of age or older
• Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.

You may not qualify if:

• Pregnancy
• Urgent/non-scheduled surgery
• Non-eligible for umbilical entry

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (10)

• Ahmad G, Baker J, Finnerty J, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2019 Jan 18;1(1):CD006583. doi: 10.1002/14651858.CD006583.pub5.

  PMID: 30657163 BACKGROUND

• Jansen FW, Kapiteyn K, Trimbos-Kemper T, Hermans J, Trimbos JB. Complications of laparoscopy: a prospective multicentre observational study. Br J Obstet Gynaecol. 1997 May;104(5):595-600. doi: 10.1111/j.1471-0528.1997.tb11539.x.

  PMID: 9166204 BACKGROUND

• Makai G, Isaacson K. Complications of gynecologic laparoscopy. Clin Obstet Gynecol. 2009 Sep;52(3):401-11. doi: 10.1097/GRF.0b013e3181b0c080.

  PMID: 19661756 BACKGROUND

• Molloy D, Kaloo PD, Cooper M, Nguyen TV. Laparoscopic entry: a literature review and analysis of techniques and complications of primary port entry. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):246-54. doi: 10.1111/j.0004-8666.2002.00246.x.

  PMID: 12230057 BACKGROUND

• Azevedo JL, Azevedo OC, Miyahira SA, Miguel GP, Becker OM Jr, Hypolito OH, Machado AC, Cardia W, Yamaguchi GA, Godinho L, Freire D, Almeida CE, Moreira CH, Freire DF. Injuries caused by Veress needle insertion for creation of pneumoperitoneum: a systematic literature review. Surg Endosc. 2009 Jul;23(7):1428-32. doi: 10.1007/s00464-009-0383-9. Epub 2009 Mar 5.

  PMID: 19263124 BACKGROUND

• Jiang X, Anderson C, Schnatz PF. The safety of direct trocar versus Veress needle for laparoscopic entry: a meta-analysis of randomized clinical trials. J Laparoendosc Adv Surg Tech A. 2012 May;22(4):362-70. doi: 10.1089/lap.2011.0432. Epub 2012 Mar 16.

  PMID: 22423957 BACKGROUND

• Krishnakumar S, Tambe P. Entry complications in laparoscopic surgery. J Gynecol Endosc Surg. 2009 Jan;1(1):4-11. doi: 10.4103/0974-1216.51902.

  PMID: 22442503 BACKGROUND

• Kendrick DB, Strout TD. The minimum clinically significant difference in patient-assigned numeric scores for pain. Am J Emerg Med. 2005 Nov;23(7):828-32. doi: 10.1016/j.ajem.2005.07.009.

  PMID: 16291435 BACKGROUND

• Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3.

  PMID: 14499431 BACKGROUND

• Foley CE, Ryan E, Huang JQ. Less is more: clinical impact of decreasing pneumoperitoneum pressures during robotic surgery. J Robot Surg. 2021 Apr;15(2):299-307. doi: 10.1007/s11701-020-01104-4. Epub 2020 Jun 22.

  PMID: 32572753 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Raanan Meyer, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raanan Meyer, MD

CONTACT

3104234073; Raanan.Meyer@cshs.org

Kacey Hamilton

CONTACT

3104234073

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 12, 2024
• Study Start: March 22, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)