Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
1 other identifier
interventional
96
1 country
2
Brief Summary
we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with Palmar's point
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2019
CompletedFirst Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2020
CompletedJuly 17, 2020
January 1, 2020
8 months
December 19, 2019
July 16, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point
the surgeon will calculate the time of surgery for similar cases in both groups and will compare between both groups according to the time factor
6 months
complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point
we will compare the number of participants with vascular or intestinal injuries in both procedures
6 months
coordination of the surgeon movement by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point
questionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy
6 months
Study Arms (3)
randomization
EXPERIMENTALPatients are randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. Group (B):- The umbilicus is the primary entry site.
group A
EXPERIMENTALthese are the patient with palmars point as primary entry site
group B
EXPERIMENTALthese are the patient with umbilicus as primary entry site
Interventions
Patients will be randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. Group (B):- The umbilicus is the primary entry site.
Eligibility Criteria
You may qualify if:
- Patients listed for diagnostic or operative laparoscopy.
You may not qualify if:
- Splenomegaly
- Hepatomegaly
- previous left upper quadrant surgery.
- midline laparotomy
- umbilical surgery
- presence of umbilical hernia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zagazig University
Zagazig, East, 44511, Egypt
Zagazig
Zagazig, East, 44511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of obstetrics and gynecology/ MD ob/gyn
Study Record Dates
First Submitted
December 19, 2019
First Posted
January 3, 2020
Study Start
December 15, 2019
Primary Completion
July 30, 2020
Study Completion
July 30, 2020
Last Updated
July 17, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share