Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery
NCT ID: NCT06305975
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-03-22
2025-03-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Blunt fascial entry
The blunt fascial entry technique will be used for patients in this arm
Blunt fascial abdominal entry
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.
Veress needle entry technique
The Veress needle entry technique will be used for patients in this arm
Veress needle abdominal entry
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.
Interventions
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Blunt fascial abdominal entry
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.
Veress needle abdominal entry
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.
Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. 18 years of age or older
4. Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Exclusion Criteria
2. Urgent/non-scheduled surgery
3. Non-eligible for umbilical entry
18 Years
FEMALE
Yes
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Raanan Meyer
Principal Investigator
Principal Investigators
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Raanan Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Kacey Hamilton
Role: CONTACT
Facility Contacts
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References
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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.
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.
Makai G, Isaacson K. Complications of gynecologic laparoscopy. Clin Obstet Gynecol. 2009 Sep;52(3):401-11. doi: 10.1097/GRF.0b013e3181b0c080.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00003169
Identifier Type: -
Identifier Source: org_study_id
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