Laparoscopic SurgeryBluntFascialNCT06305975
Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery
A study testing Blunt fascial abdominal entry and Veress needle abdominal entry in people with Laparoscopic Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Blunt fascial abdominal entry and Veress needle abdominal entry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 18 years of age or older
- Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Who cannot join
- Pregnancy
- Urgent/non-scheduled surgery
- Non-eligible for umbilical entry
Trial locations and contacts
1 site in 1 country.
Kacey Hamilton contact
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Raanan Meyer, MD, 310-423-9268, Raanan.Meyer@cshs.org
Kacey Hamilton, MD, 3104239268, Kacey.Hamilton@cshs.org
About this study
Official title: Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery: A Randomized Controlled 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.
Read more
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.
Read the detailed description
This will be a single-center, single-blinded randomized controlled trial evaluating the impact of peritoneal entry technique on insufflation times, entry failure, post-operative pain and surgical outcomes among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that the blunt fascial entry technique will be associated with shorter insufflation times with no effect on other surgical outcomes. The study will include 2 groups corresponding to the entry techniques: blunt facial entry and Veress needle entry. Participants will be 1:1 allocated to each technique by block randomization.
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
- Laparoscopic Surgery
- Being tested
- Blunt fascial abdominal entry, Veress needle abdominal entry
- Keywords
- Abdominal entry, Laparoscopy, Insufflation time, Postoperative pain, Safety
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blunt fascial abdominal entryProcedure or surgery
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 entryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Blunt fascial entry | Experimental | The blunt fascial entry technique will be used for patients in this arm Receives: Procedure: Blunt fascial abdominal entry |
| Veress needle entry technique | Active comparator | The Veress needle entry technique will be used for patients in this arm Receives: Procedure: Veress needle abdominal entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insufflation time
The time it takes to insufflate the abdominal cavity to 15 mm Hg.
Measured: Intraoperative
Success upon peritoneal entry
Successful abdominal entry in the first trial
Measured: Intraoperative
Secondary outcomes (5)
Intraoperative complications
- Intraoperative complications upon peritoneal entry
Measured: Intraoperative
Postoperative complications
Any postoperative complications
Measured: Postoperative period within 30 days of surgery
Patients pain scores
- First reported pain score in PACU using the numerical rating scale (0-10).
- Last reported pain score in PACU prior to discharge using the numerical rating scale (0-10).
Measured: Day of surgery, postoperatively and before discharge
Analgesics use
- Total analgesic requirements in PACU
Measured: Day of surgery, postoperatively and before discharge
Length of hospital stay
- Length of stay- from arrival to PACU to discharge home)
Measured: Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start22 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raanan Meyer, Cedars-Sinai Medical Center
- Investigators
- Raanan Meyer, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305975
- Sponsor's protocol ID
- STUDY00003169
- Acronym
- BluntFascial
- Status last verified
- May 2024
- First submitted
- 22 Feb 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30657163Jansen 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.
PubMed 9166204Makai G, Isaacson K. Complications of gynecologic laparoscopy. Clin Obstet Gynecol. 2009 Sep;52(3):401-11. doi: 10.1097/GRF.0b013e3181b0c080.
PubMed 19661756Molloy 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.
PubMed 12230057Azevedo 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.
PubMed 19263124Jiang 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.
PubMed 22423957Krishnakumar S, Tambe P. Entry complications in laparoscopic surgery. J Gynecol Endosc Surg. 2009 Jan;1(1):4-11. doi: 10.4103/0974-1216.51902.
PubMed 22442503Kendrick 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.
PubMed 16291435Cepeda 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.
PubMed 14499431Foley 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.
PubMed 32572753
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06305975
- Acronym / sponsor ID
- BluntFascial / STUDY00003169
- Conditions
- Laparoscopic Surgery
- Keywords
- Abdominal entry, Laparoscopy, Insufflation time, Postoperative pain, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a single-center, single-blinded randomized controlled trial evaluating the impact of peritoneal entry technique on insufflation times, entry failure, post-operative pain and surgical outcomes among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that the blunt fascial entry technique will be associated with shorter insufflation times with no effect on other surgical outcomes. The study will include 2 groups corresponding to the entry techniques: blunt facial entry and Veress needle entry. Participants will be 1:1 allocated to each technique by block randomization.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blunt fascial entry | Experimental | Procedure: Blunt fascial abdominal entryThe blunt fascial entry technique will be used for patients in this arm |
| Veress needle entry technique | Active comparator | Procedure: Veress needle abdominal entryThe Veress needle entry technique will be used for patients in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- 18 years of age or older
- Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
Key exclusion criteria (3 listed)
- Pregnancy
- Urgent/non-scheduled surgery
- Non-eligible for umbilical entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blunt fascial abdominal entryBlunt 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. | Procedure or surgery | Blunt fascial entry |
| Veress needle abdominal entryVeress 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. | Procedure or surgery | Veress needle entry technique |
Primary outcome
Insufflation time
Time frame: Intraoperative
The time it takes to insufflate the abdominal cavity to 15 mm Hg.
Success upon peritoneal entry
Time frame: Intraoperative
Successful abdominal entry in the first trial
5 secondary outcomes
Intraoperative complications
Time frame: Intraoperative
Postoperative complications
Time frame: Postoperative period within 30 days of surgery
Patients pain scores
Time frame: Day of surgery, postoperatively and before discharge
Analgesics use
Time frame: Day of surgery, postoperatively and before discharge
Length of hospital stay
Time frame: Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 30657163Ahmad 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.
- Background: PubMed 9166204Jansen 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.
- Background: PubMed 19661756Makai G, Isaacson K. Complications of gynecologic laparoscopy. Clin Obstet Gynecol. 2009 Sep;52(3):401-11. doi: 10.1097/GRF.0b013e3181b0c080.
- Background: PubMed 12230057Molloy 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.
- Background: PubMed 19263124Azevedo 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.
- Background: PubMed 22423957Jiang 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.
- Background: PubMed 22442503Krishnakumar S, Tambe P. Entry complications in laparoscopic surgery. J Gynecol Endosc Surg. 2009 Jan;1(1):4-11. doi: 10.4103/0974-1216.51902.
- Background: PubMed 16291435Kendrick 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.
- Background: PubMed 14499431Cepeda 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.
- Background: PubMed 32572753Foley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kacey Hamilton contact
Raanan Meyer, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blunt fascial abdominal entry and Veress needle abdominal entry in people with Laparoscopic Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raanan Meyer, MD (3104234073, Raanan.Meyer@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insufflation time (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305975, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.