Blade Finger Technique for Safe Laparoscopic Entery (new technique)

A Prospective Randomized Controlled Trial on Safe Laparoscopic Access and Ports Insertion Using the Blade-Finger Technique

blade-finger technique is a new technique for laparoscopic access which is safe

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Safety Issues; Insufflation; Operative Surgical Procedure
• Intervention / Treatment: Procedure: finger-blade technique; Procedure: Hasson's technique; Procedure: veress needle technique

Detailed Description

after optaining irb approval and patients consented, they were divided into 3 groups to whom one of the techniques of laparoscopic entery was applied and there was a comparison between these groups

• Study Type: Interventional
• Enrollment (Actual): 1005
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients more than 18 year-old.
• underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to May, 2022.

Exclusion Criteria:

• Patients with one or more previous abdominal surgery (upper, lower or upper and lower midline scars).
• Patients with distended abdomen due to bowel obstruction.
• Patients with uncorrected coagulopathy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group a; the group we used our new blade-finger technique	Procedure: finger-blade technique; laparoscopic access technique for group a; Other Names: laparoscopic access technique
Experimental: group b; the group we used Hasson's technique	Procedure: Hasson's technique; laparoscopic access technique for group b; Other Names: laparoscopic access technique
Experimental: group c; the group we used veress needle technique	Procedure: veress needle technique; laparoscopic access technique for group c; Other Names: laparoscopic access technique for group c

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time needed to access the peritoneal cavity	the time of the procedure of access	the first 15 minutes of operation
numbers of trials till the good peritoneal access achieved	number of trials till succeeded peritoneal access	the first 15 minutes of operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of complications	bleeding, bowel injury	the first 15 minutes of operation

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: veress needle; Hasson's technique; laparoscopic access; blade-finger technique
• Other Study ID Numbers: zuh 247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No