Laparoscopic Entry TechniqueNCT02804529
A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum
A study testing Veress needle in people with Laparoscopic Entry Technique, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The Palmer's point and periumbilical region are the common laparoscopic entry site to establish the pneumoperitoneum. In the present study, the investigators assess the safety and feasibility of Meng's point as a new laparoscopic entry site in cases to perform the gastrointestinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Entry Technique
- What is being tested?
- Veress needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient suitable for laparoscopic abdominal surgery
Who cannot join
- previous abdominal surgeries
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Fanqiang Meng, MA, +8684206168, mengfq75@163.com
About this study
Official title: A Comparison of Three Different Puncture Points to Establish the Pneumoperitoneum in Laparoscopic Gastrointestinal Surgery: A Randomized Prospective Trial
The Palmer's point and periumbilical region are the common laparoscopic entry site to establish the pneumoperitoneum. In the present study, the investigators assess the safety and feasibility of Meng's point as a new laparoscopic entry site in cases to perform the gastrointestinal surgery.
This prospective and randomized study will compare the three entry techniques with regard to:
- Complications related to the entry technique
- Time taken to enter the abdomen.
- The number of attempts taken to enter the abdomen
Read the detailed description
Patients of China-Japan Friendship Hospital that are having a laparoscopic surgery for general surgery purposes will participate in the study. Patients with previous abdominal surgeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the three arms of the trial. All patient information will be confidential and only be available to researches involved in the study. Only one attending surgeon of the General Surgery Department of China-Japan Friendship Hospital will participate in the study. 90 patients will be recruited over one year period and the data will be analysed by a statistician.
- Conditions
- Laparoscopic Entry Technique
- Being tested
- Veress needle
- Keywords
- Laparoscopic entry, Meng's point, Veress needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veress needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Meng's Point entry | Experimental | Meng's entry involved a 0.2 cm horizontal or vertical incision using the Veress needle in the cross of lateral border of the left rectus abdominis and rib arch. Receives: Device: Veress needle |
| Palmer's Point entry | Experimental | Palmer's entry involved a 0.2 cm horizontal or vertical incision with the Veress needle in the left midclavicular line approximately 3 cm caudal to the 10th rib Receives: Device: Veress needle |
| Periumbilllicus entry | Experimental | Periumbilllicus entry involved a 0.2 cm horizontal or vertical midline incision using the Veress needle in the lower or uper border of the umbilicus. Receives: Device: Veress needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications during entry in laparoscopy
Measured: During surgery
Secondary outcomes (1)
Time to enter in the abdominal cavity
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Entry TechniqueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanqiang Meng, China-Japan Friendship Hospital
- Investigators
- Fanqiang Meng, MD,CSCRS, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804529
- Sponsor's protocol ID
- ChinaJapanFH Meng001
- Status last verified
- Feb 2018
- First submitted
- 15 Jun 2016
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Granata M, Tsimpanakos I, Moeity F, Magos A. Are we underutilizing Palmer's point entry in gynecologic laparoscopy? Fertil Steril. 2010 Dec;94(7):2716-9. doi: 10.1016/j.fertnstert.2010.03.055. Epub 2010 May 10.
PubMed 20452584Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.
PubMed 24103531Ahmad G, Gent D, Henderson D, O'Flynn H, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2015 Aug 31;8:CD006583. doi: 10.1002/14651858.CD006583.pub4.
PubMed 26329306
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Different Puncture Points to Establish the Pneumoperitoneum in Laparoscopic Gastrointestinal Surgery: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT02804529
- Acronym / sponsor ID
- ChinaJapanFH Meng001
- Conditions
- Laparoscopic Entry Technique
- Keywords
- Laparoscopic entry, Meng's point, Veress needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 17 Jun 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.
The Palmer's point and periumbilical region are the common laparoscopic entry site to establish the pneumoperitoneum. In the present study, the investigators assess the safety and feasibility of Meng's point as a new laparoscopic entry site in cases to perform the gastrointestinal surgery.
This prospective and randomized study will compare the three entry techniques with regard to:
- Complications related to the entry technique
- Time taken to enter the abdomen.
- The number of attempts taken to enter the abdomen
Detailed description
Patients of China-Japan Friendship Hospital that are having a laparoscopic surgery for general surgery purposes will participate in the study. Patients with previous abdominal surgeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the three arms of the trial. All patient information will be confidential and only be available to researches involved in the study. Only one attending surgeon of the General Surgery Department of China-Japan Friendship Hospital will participate in the study. 90 patients will be recruited over one year period and the data will be analysed by a statistician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meng's Point entry | Experimental | Device: Veress needleMeng's entry involved a 0.2 cm horizontal or vertical incision using the Veress needle in the cross of lateral border of the left rectus abdominis and rib arch. |
| Palmer's Point entry | Experimental | Device: Veress needlePalmer's entry involved a 0.2 cm horizontal or vertical incision with the Veress needle in the left midclavicular line approximately 3 cm caudal to the 10th rib |
| Periumbilllicus entry | Experimental | Device: Veress needlePeriumbilllicus entry involved a 0.2 cm horizontal or vertical midline incision using the Veress needle in the lower or uper border of the umbilicus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient suitable for laparoscopic abdominal surgery
Key exclusion criteria (1 listed)
- previous abdominal surgeries
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 | Device | Meng's Point entry, Palmer's Point entry, Periumbilllicus entry |
Primary outcome
Complications during entry in laparoscopy
Time frame: During surgery
1 secondary outcome
Time to enter in the abdominal cavity
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Background: PubMed 20452584Granata M, Tsimpanakos I, Moeity F, Magos A. Are we underutilizing Palmer's point entry in gynecologic laparoscopy? Fertil Steril. 2010 Dec;94(7):2716-9. doi: 10.1016/j.fertnstert.2010.03.055. Epub 2010 May 10.
- Background: PubMed 24103531Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.
- Background: PubMed 26329306Ahmad G, Gent D, Henderson D, O'Flynn H, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2015 Aug 31;8:CD006583. doi: 10.1002/14651858.CD006583.pub4.
- Individual participant dataSharing planned: Yes
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.
Fanqiang Meng, MD,CSCRS study director
China-Japan Friendship Hospital
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 in people with Laparoscopic Entry Technique, run by China-Japan Friendship Hospital at 1 site in China.
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 1 inclusion and 1 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 Feb 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 China. 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 Fangqiang Meng, MD,CSCRS (861084206168, mengfq75@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications during entry in laparoscopy (time frame: During surgery). 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 NCT02804529, which also lists 3 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 Feb 2018.