Subserosal Laparoscopic Cholecystectomy | NCT05770128

Studies
Subserosal Laparoscopic Cholecystectomy

NCT05770128

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 15, 2023Actual

Enrollment

65Estimated

Phase

Not provided

Conditions

Cholecystitis

Interventions

laparoscope

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Estimated

Primary Completion Date

Nov 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Oct 25, 2021

First Submission Date that Met QC Criteria

Mar 14, 2023

First Posted Date

Mar 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscope	Procedure	subserosal manipulation of gallbladder with laparoscope .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique.	incidence of bleeding after subserosal laparoscopic cholecystectomy in comparison to conventional technique.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult with age of or above 18 years.
Diagnosis of chronic cholecystitis , symptomatic cholelithiasis

Exclusion Criteria:

Previous operation or adhesion
severe Acute Calculus pancreatitis
gall bladder cancer
Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)
Recurrent cases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

any patient admitted to surgical department wth age above 18 years old suffering & diagnosed of chronic cholecystitis , symptomatic cholelithiasis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed M. Hussein, resident	Contact	+201010729020		ahmed.s7s1929@gmail.com
Abdallah B. Abdallah, professor	Contact	+201000002283		badawy@aun.edu.eg

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020706	Laparoscopes

Ancestor Terms

ID	Term
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D013523	Surgical Equipment

Browse Leaves

Not provided

Browse Branches

Not provided