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A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum

Primary Purpose

Laparoscopic Entry Technique

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Veress needle
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Entry Technique focused on measuring Laparoscopic entry, Meng's point, Veress needle

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient suitable for laparoscopic abdominal surgery

Exclusion Criteria:

  • previous abdominal surgeries

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Meng's Point entry

Palmer's Point entry

Periumbilllicus entry

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

Complications during entry in laparoscopy

Secondary Outcome Measures

Time to enter in the abdominal cavity

Full Information

First Posted
June 15, 2016
Last Updated
February 8, 2018
Sponsor
China-Japan Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02804529
Brief Title
A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum
Official Title
A Comparison of Three Different Puncture Points to Establish the Pneumoperitoneum in Laparoscopic Gastrointestinal Surgery: A Randomized Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Entry Technique
Keywords
Laparoscopic entry, Meng's point, Veress needle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meng's Point entry
Arm Type
Experimental
Arm Description
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.
Arm Title
Palmer's Point entry
Arm Type
Experimental
Arm Description
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
Arm Title
Periumbilllicus entry
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Veress needle
Primary Outcome Measure Information:
Title
Complications during entry in laparoscopy
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Time to enter in the abdominal cavity
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient suitable for laparoscopic abdominal surgery Exclusion Criteria: previous abdominal surgeries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangqiang Meng, MD,CSCRS
Phone
861084206168
Email
mengfq75@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chunmao Wang, MD.,PhD.
Phone
861084206168
Email
bjchest@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanqiang Meng, MD,CSCRS
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanqiang Meng, MA
Phone
+8684206168
Email
mengfq75@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
20452584
Citation
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.
Results Reference
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PubMed Identifier
24103531
Citation
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.
Results Reference
background
PubMed Identifier
26329306
Citation
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.
Results Reference
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A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum

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