LaparoscopyNCT02896036
Veress Entry With/Without Concomitant CO2
A study testing Veress needle entry with concomitant CO2 and Veress needle entry with subsequent CO2 in people with Laparoscopy and Laparoscopic Surgery, run by University of South Florida at 1 site in United States.
Trial summary
Purpose: The primary objective is to compare the time required for adequate intraperitoneal insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the number of attempts needed before successful entry is achieved. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Laparoscopy, Laparoscopic Surgery, Insufflation
- What is being tested?
- Veress needle entry with concomitant CO2 and Veress needle entry with subsequent CO2
- 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
- Aug 2016to 10 Mar 2018
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All female patients within the ages of 18-70 presenting to TGH for benign gynecologic laparoscopic surgery performed by the study investigators. The following surgeries will be considered as part of the study:
- Diagnostic laparoscopy
- Laparoscopic adnexal surgery
- Laparoscopic hysterectomy
- Laparoscopic myomectomy
- Robotic assisted hysterectomy
- Robotic assisted myomectomy
Who cannot join
- Patients unable to provide informed consent
- Previous midline laparotomy
- 3 or more previous cesarean sections through a Pfannenstiel incision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Entry Technique With a Veress Needle Insertion With and Without Concomitant CO2 Insufflation - Does it Matter?
Purpose: The primary objective is to compare the time required for adequate intraperitoneal insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the number of attempts needed before successful entry is achieved. The secondary objectives will evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental injury between the two techniques.
Study design: prospective randomized control trial
Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation, and will require less number of attempts to achieve successful entry.
Read the detailed description
Subject Recruitment and Consent:
All female patients age 18-70 scheduled for benign gynecologic laparoscopic surgery at TGH by a participating attending surgeon will be recruited. Each participant will be educated about the study; its objectives, potential benefits and risks, and the research team will obtain informed consent. Plan to enroll 90 participants.
Materials and Methods:
This will be a randomized control trial in which participants will be randomly assigned to have laparoscopic entry with Veress needle connected to CO2 tubing for concomitant insufflation versus Veress needle entry with subsequent connection to CO2 tubing for insufflation. The investigators will inform the patients about the two entry techniques during the pre-operative office visit. Participants will be consented to participate in the study prior to the surgery by the study research coordinators during their pre-operative visit. Patients who do not consent for the study will still undergo the scheduled procedure with standard entry technique as clinically indicated by their provider. Randomization will occur in the operating room just before the surgery starts. The healthcare provider performing the procedure will open the next sequentially numbered envelope, within which there will be a piece of paper indicating the entry technique to be performed. This will then be recorded in the study log. The study log will include enrolled participants, assigned study number which will range from 001 to the minimum number of participants required for the study as indicated by sample size calculation (see below). The participant will be positioned in the dorsal lithotomy position and prepped and draped in the standard fashion. Preoperative antibiotics will be provided as per standard indication for the procedure. For the group of participants who will be randomized to concomitant CO2 insufflation; the Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the Veress will be withdrawn and reinserted up to 3 times. A failed entry will be called if the peritoneal cavity cannot be insufflated after 3 attempts. For the other group of patients who will be randomized to subsequent CO2 insufflation; the Veress needle will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by insertion of the Veress needle. The gas insufflation will be started and the opening pressure will be noted. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the Veress needle will be withdrawn and reinserted up to 3 times. Each time the needle is to reinserted, the CO2 insufflator will be switched off until the location of the Veress needle is felt to be adequate. The time will be recorded from incision to the time it takes to achieve intraperitoneal pressure of 15 mmHg. In addition to the above primary and secondary outcomes of the study, participant demographic information, procedure specific variables and outcomes will be collected and recorded in the study log (See data collection sheet). Common laparoscopic complications will also be recorded, including the following:
- Vascular injury: any tear or injury to any intraabdominal blood vessels.
- Visceral injury: any serosal (superficial) or full thickness (deep) injury to the small or the large bowel.
- Gas embolism: entrapment of carbon dioxide in an injured vein, artery or solid organ, and results in blockage of the right ventricle (RV) or pulmonary artery
- Solid organ injury: any injury of a solid abdominal or pelvic organ including but not limited to, liver, spleen or the uterus.
- Failed entry: failure to establish pneumoperitoneum after 3 attempts of Veress insufflation.
- Extraperitoneal insufflation: insufflating the preperitoneal space with carbon dioxide.
- Omental injury: any injury to the greater omentum that results in bleeding of omental insufflation.
Sample size: 90 patients will be recruited based on the sample size calculations already performed.
- Being tested
- Veress needle entry with concomitant CO2, Veress needle entry with subsequent CO2
- Keywords
- Laparoscopic Entry, Veress Needle, Intraperitoneal insufflation, Time, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veress needle entry with concomitant CO2Procedure or surgery
The Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle.
Veress needle entry with subsequent CO2Procedure or surgery
A skin incision will be made with the scalpel. The Veress needle will be inserted until intraperitoneal location obtained. This will be followed by starting CO2 gas insufflation until the standard 15 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Veress needle entry with concomitant CO2 | Experimental | For the group of participants who will be randomized to concomitant CO2 insufflation; the Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the veress will be withdrawn and reinserted up to 3 times. A failed entry will be called if the peritoneal cavity cannot be insufflated after 3 attempts. Receives: Procedure: Veress needle entry with concomitant CO2 |
| Veress needle entry with subsequent CO2 | Active comparator | For the other group of participants who will be randomized to subsequent CO2 insufflation; the Veress needle will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by insertion of the Veress needle. The gas insufflation will be started and the opening pressure will be noted. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the Veress needle will be withdrawn and reinserted up to 3 times. Each time the needle is to reinserted, the CO2 insufflator will be switched off until the location of the Veress needle is felt to be adequate. Receives: Procedure: Veress needle entry with subsequent CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for adequate intraperitoneal insufflation.
Time from insertion of Veress to insufflation of peritoneum to 15 mmHg.
Measured: intraoperative
Secondary outcomes (8)
Evaluate rates of failed entry between the two techniques
Evaluate occurrence of failed entry (more than 3 attempts with the Veress without intraperitoneal insufflation)
Measured: intraoperative
Evaluate rates of extraperitoneal insufflation between the two techniques
Measured: intraoperative
Evaluate rates of vascular injury between the two techniques
Measured: intraoperative
Evaluate rates of visceral injury between the two techniques
Measured: intraoperative
Evaluate rates of gas embolism between the two techniques
omental injury between the two techniques
Measured: intraoperative
Evaluate rates of solid organ injury between the two techniques
Measured: intraoperative
Evaluate rates of omental injury between the two techniques
Measured: intraoperative
Evaluate number of entry attempts.
Record the number of attempts taken with Veress needle to obtain successful intraperitoneal entry.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion10 Mar 2018
- Study completion10 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Tampa General Hospital
- Responsible party
- Sponsor
- Investigators
- Emad Mikhail, MD, Principal investigator, University of South Florida Department of Obstetrics and GynecologyAnthony Imudia, MD, Study director, University of South Florida Department of Obstetrics and GynecologyElisabeth Sappenfield, MD, Study chair, University of South Florida Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896036
- Sponsor's protocol ID
- Pro00025352
- Status last verified
- Mar 2018
- First submitted
- 31 May 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Entry Technique With a Veress Needle Insertion With and Without Concomitant CO2 Insufflation - Does it Matter?
- ClinicalTrials.gov ID
- NCT02896036
- Acronym / sponsor ID
- Pro00025352
- Keywords
- Laparoscopic Entry, Veress Needle, Intraperitoneal insufflation, Time, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Tampa General Hospital
- Study start
- Aug 2016 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 10 Mar 2018 (actual)
- First posted
- 12 Sep 2016 (estimated)
- 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.
Purpose: The primary objective is to compare the time required for adequate intraperitoneal insufflation (from skin incision to reaching intraperitoneal pressure of 15 mmHg). Also the number of attempts needed before successful entry is achieved. The secondary objectives will evaluate rates of secondary outcomes measures such as; failed entry, extra peritoneal insufflation, vascular injury, visceral injury, gas embolism, solid organ injury, and omental injury between the two techniques.
Study design: prospective randomized control trial
Hypothesis: The investigators hypothesize that participant's undergoing laparoscopic surgery for benign Gynecologic indications at TGH who undergo laparoscopic entry technique of Veress needle entry with concomitant CO2 insufflation will require less time to achieve a 15 mmHg of intraperitoneal pressure as opposed to Veress needle entry with subsequent CO2 insufflation, and will require less number of attempts to achieve successful entry.
Detailed description
Subject Recruitment and Consent:
All female patients age 18-70 scheduled for benign gynecologic laparoscopic surgery at TGH by a participating attending surgeon will be recruited. Each participant will be educated about the study; its objectives, potential benefits and risks, and the research team will obtain informed consent. Plan to enroll 90 participants.
Materials and Methods:
This will be a randomized control trial in which participants will be randomly assigned to have laparoscopic entry with Veress needle connected to CO2 tubing for concomitant insufflation versus Veress needle entry with subsequent connection to CO2 tubing for insufflation. The investigators will inform the patients about the two entry techniques during the pre-operative office visit. Participants will be consented to participate in the study prior to the surgery by the study research coordinators during their pre-operative visit. Patients who do not consent for the study will still undergo the scheduled procedure with standard entry technique as clinically indicated by their provider. Randomization will occur in the operating room just before the surgery starts. The healthcare provider performing the procedure will open the next sequentially numbered envelope, within which there will be a piece of paper indicating the entry technique to be performed. This will then be recorded in the study log. The study log will include enrolled participants, assigned study number which will range from 001 to the minimum number of participants required for the study as indicated by sample size calculation (see below). The participant will be positioned in the dorsal lithotomy position and prepped and draped in the standard fashion. Preoperative antibiotics will be provided as per standard indication for the procedure. For the group of participants who will be randomized to concomitant CO2 insufflation; the Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the Veress will be withdrawn and reinserted up to 3 times. A failed entry will be called if the peritoneal cavity cannot be insufflated after 3 attempts. For the other group of patients who will be randomized to subsequent CO2 insufflation; the Veress needle will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by insertion of the Veress needle. The gas insufflation will be started and the opening pressure will be noted. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the Veress needle will be withdrawn and reinserted up to 3 times. Each time the needle is to reinserted, the CO2 insufflator will be switched off until the location of the Veress needle is felt to be adequate. The time will be recorded from incision to the time it takes to achieve intraperitoneal pressure of 15 mmHg. In addition to the above primary and secondary outcomes of the study, participant demographic information, procedure specific variables and outcomes will be collected and recorded in the study log (See data collection sheet). Common laparoscopic complications will also be recorded, including the following:
- Vascular injury: any tear or injury to any intraabdominal blood vessels.
- Visceral injury: any serosal (superficial) or full thickness (deep) injury to the small or the large bowel.
- Gas embolism: entrapment of carbon dioxide in an injured vein, artery or solid organ, and results in blockage of the right ventricle (RV) or pulmonary artery
- Solid organ injury: any injury of a solid abdominal or pelvic organ including but not limited to, liver, spleen or the uterus.
- Failed entry: failure to establish pneumoperitoneum after 3 attempts of Veress insufflation.
- Extraperitoneal insufflation: insufflating the preperitoneal space with carbon dioxide.
- Omental injury: any injury to the greater omentum that results in bleeding of omental insufflation.
Sample size: 90 patients will be recruited based on the sample size calculations already performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veress needle entry with concomitant CO2 | Experimental | Procedure: Veress needle entry with concomitant CO2For the group of participants who will be randomized to concomitant CO2 insufflation; the Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the veress will be withdrawn and reinserted up to 3 times. A failed entry will be called if the peritoneal cavity cannot be insufflated after 3 attempts. |
| Veress needle entry with subsequent CO2 | Active comparator | Procedure: Veress needle entry with subsequent CO2For the other group of participants who will be randomized to subsequent CO2 insufflation; the Veress needle will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by insertion of the Veress needle. The gas insufflation will be started and the opening pressure will be noted. If the opening pressure is less than or equal to 10 mmHg, the process of insufflation will be allowed to continue. In case of a higher opening pressure, the Veress needle will be withdrawn and reinserted up to 3 times. Each time the needle is to reinserted, the CO2 insufflator will be switched off until the location of the Veress needle is felt to be adequate. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All female patients within the ages of 18-70 presenting to TGH for benign gynecologic laparoscopic surgery performed by the study investigators. The following surgeries will be considered as part of the study:
Key exclusion criteria (3 listed)
- Patients unable to provide informed consent
- Previous midline laparotomy
- 3 or more previous cesarean sections through a Pfannenstiel incision
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 |
|---|---|---|
| Veress needle entry with concomitant CO2The Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle. | Procedure or surgery | Veress needle entry with concomitant CO2 |
| Veress needle entry with subsequent CO2A skin incision will be made with the scalpel. The Veress needle will be inserted until intraperitoneal location obtained. This will be followed by starting CO2 gas insufflation until the standard 15 mmHg. | Procedure or surgery | Veress needle entry with subsequent CO2 |
Primary outcome
Time required for adequate intraperitoneal insufflation.
Time frame: intraoperative
Time from insertion of Veress to insufflation of peritoneum to 15 mmHg.
8 secondary outcomes
Evaluate rates of failed entry between the two techniques
Time frame: intraoperative
Evaluate rates of extraperitoneal insufflation between the two techniques
Time frame: intraoperative
Evaluate rates of vascular injury between the two techniques
Time frame: intraoperative
Evaluate rates of visceral injury between the two techniques
Time frame: intraoperative
Evaluate rates of gas embolism between the two techniques
Time frame: intraoperative
Evaluate rates of solid organ injury between the two techniques
Time frame: intraoperative
Evaluate rates of omental injury between the two techniques
Time frame: intraoperative
Evaluate number of entry attempts.
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- 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.
Emad Mikhail, MD principal investigator
University of South Florida Department of Obstetrics and Gynecology
Anthony Imudia, MD study director
University of South Florida Department of Obstetrics and Gynecology
Elisabeth Sappenfield, MD study chair
University of South Florida Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veress needle entry with concomitant CO2 and Veress needle entry with subsequent CO2 in people with Laparoscopy and Laparoscopic Surgery, run by University of South Florida 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 7 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: finished, as of the sponsor's last update on 30 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for adequate intraperitoneal insufflation. (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2018.