A Comparison of Three Different Entry Points to Establish the Pneumoperitoneum

February 8, 2018 updated by: Fanqiang Meng, China-Japan Friendship Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient suitable for laparoscopic abdominal surgery

Exclusion Criteria:

  • previous abdominal surgeries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complications during entry in laparoscopy
Time Frame: During surgery
During surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to enter in the abdominal cavity
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Investigators

  • Study Director: Fanqiang Meng, MD,CSCRS, China-Japan Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinaJapanFH Meng001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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