NCT02804529

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

June 15, 2016

Last Update Submit

February 8, 2018

Conditions

Laparoscopic Entry Technique

Keywords

Laparoscopic entryMeng's pointVeress needle

Outcome Measures

Primary Outcomes (1)

  • Complications during entry in laparoscopy

    During surgery

Secondary Outcomes (1)

  • Time to enter in the abdominal cavity

    During surgery

Study Arms (3)

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.

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

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.

Device: Veress needle

Interventions

Veress needleDEVICE
Meng's Point entryPalmer's Point entryPeriumbilllicus entry

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient suitable for laparoscopic abdominal surgery

You may not qualify if:

  • previous abdominal surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20452584BACKGROUND

  • 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.

    PMID: 24103531BACKGROUND

  • 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.

    PMID: 26329306BACKGROUND

Study Officials

  • Fanqiang Meng, MD,CSCRS

    China-Japan Friendship Hospital

    STUDY DIRECTOR

Central Study Contacts

Fangqiang Meng, MD,CSCRS

CONTACT

861084206168mengfq75@163.com

Chunmao Wang, MD.,PhD.

CONTACT

861084206168bjchest@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD.

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

February 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)