NCT05565508

Brief Summary

the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

September 27, 2022

Last Update Submit

October 1, 2022

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

  • time needed to access the peritoneal cavity

    time needed to access the peritoneal cavity

    the first 15 minutes of operation

  • numbers of trials till the good peritoneal access achieved

    numbers of trials till the good peritoneal access achieved

    the first 15 minutes of operation

Secondary Outcomes (1)

  • rate of complications

    the first 15 minutes of operation

Study Arms (2)

new laparoscopic access technique

EXPERIMENTAL

in which we used our new laparoscopic access

Procedure: new laparoscopic access technique for group a

Hasson's technique

EXPERIMENTAL

in which we used the well-known Hasson's technique for primary laparoscopic access

Procedure: Hasson's technique for laparoscopic access in group b

Interventions

new laparoscopic access technique for group aPROCEDURE

new laparoscopic access technique through the epigastric region

Also known as: new laparoscopic access technique
new laparoscopic access technique
Hasson's technique for laparoscopic access in group bPROCEDURE

Hasson's technique for laparoscopic access in group b

Hasson's technique

Eligibility Criteria

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

You may qualify if:

  • Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery.
  • underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022.

You may not qualify if:

  • 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
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Dr

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 4, 2022

Study Start

March 20, 2020

Primary Completion

July 17, 2022

Study Completion

July 20, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations

EG(1)