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Status unknownNCT02804529Updated Feb 9, 2018

A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum

An interventional study of Veress needle in Laparoscopic Entry Technique, sponsored by China-Japan Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-02-09.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Laparoscopic Entry Technique

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Keywords

  • Laparoscopic entry
  • Meng's point
  • Veress needle
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In context

Pneumoperitoneum

149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.

This study's planned enrollment of 90 is above the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.

Browse Pneumoperitoneum studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Any patient suitable for laparoscopic abdominal surgery

Exclusion criteria

Exclusion Criteria:

  • previous abdominal surgeries
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Meng's Point entry

    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.

    Device: Veress needle

  • Experimental
    Palmer's Point entry

    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

    Device: Veress needle

  • Experimental
    Periumbilllicus entry

    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.

    Device: Veress needle

Interventions

  • DeviceVeress needle
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What researchers measure

Primary outcomes

  1. Complications during entry in laparoscopy

    Time frame: During surgery

Secondary outcomes

  1. Time to enter in the abdominal cavity

    Time frame: During surgery

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Study locations

1 of 1 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, Beijing 100029, China
    Recruiting
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References and documents

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 20452584 ↗
  • Angioli 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 24103531 ↗
  • Ahmad 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 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02804529
Lead sponsor
China-Japan Friendship Hospital
Responsible party
Fanqiang Meng (MD. PhD., China-Japan Friendship Hospital) — Principal investigator
First posted
Jun 17, 2016
Start date
Jul 2016
Primary completion
Jun 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Feb 9, 2018

Study contacts

Fangqiang Meng, MD,CSCRS
Contact
mengfq75@163.com
861084206168
Chunmao Wang, MD.,PhD.
Contact
bjchest@163.com
861084206168
Fanqiang Meng, MD,CSCRS
study director · China-Japan Friendship Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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