NCT05475470

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,005

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 20, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

July 24, 2022

Last Update Submit

July 24, 2022

Conditions

Laparoscopic SurgeryOperative Surgical ProcedureInsufflationSafety Issues

Keywords

veress needleHasson's techniquelaparoscopic accessblade-finger technique

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • rate of complications

    the first 15 minutes of operation

Study Arms (3)

group a

EXPERIMENTAL

the group we used our new blade-finger technique

Procedure: finger-blade technique

group b

EXPERIMENTAL

the group we used Hasson's technique

Procedure: Hasson's technique

group c

EXPERIMENTAL

the group we used veress needle technique

Procedure: veress needle technique

Interventions

finger-blade techniquePROCEDURE

laparoscopic access technique for group a

Also known as: laparoscopic access technique
group a
Hasson's techniquePROCEDURE

laparoscopic access technique for group b

Also known as: laparoscopic access technique
group b
veress needle techniquePROCEDURE

laparoscopic access technique for group c

Also known as: laparoscopic access technique for group c
group c

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 27, 2022

Study Start

March 20, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations

EG(1)