Blade Finger Technique for Safe Laparoscopic Entery

Safety Issues Clinical Trial

— new technique  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05475470
• Other study ID #: zuh 247
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1005
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insufflation
• Laparoscopic Surgery
• Safety Issues

Intervention

Procedure:
• finger-blade technique
laparoscopic access technique for group a
• Hasson's technique
laparoscopic access technique for group b
• veress needle technique
laparoscopic access technique for group c

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time needed to access the peritoneal cavity	the time of the procedure of access	the first 15 minutes of operation
Primary	numbers of trials till the good peritoneal access achieved	number of trials till succeeded peritoneal access	the first 15 minutes of operation
Secondary	rate of complications	bleeding, bowel injury	the first 15 minutes of operation