Intraoperative Spillage of Bile and Gallstones During Lap... | NCT04041726

Studies
Intraoperative Spillage of Bile and Gallstones During Laparoscopic Cholecysetectomy

NCT04041726

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 1, 2019Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Cholecystitis; Gallstone

Interventions

Not provided

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

Jul 2019

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

Sep 1, 2019Estimated

Primary Completion Date

Sep 1, 2020Estimated

Completion Date

Oct 1, 2020Estimated

First Submitted Date

Jul 27, 2019

First Submission Date that Met QC Criteria

Jul 30, 2019

First Posted Date

Aug 1, 2019Actual

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

Jul 30, 2019

Last Update Posted Date

Aug 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omar mohamed ahmed mohamed, Resident at general surgery department, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

determine the most important factors which is responsible for the outcome post bile and gallstones spillage during laparoscopic cholecystectomy
the management of complications of bile and gallstones spillage

Detailed Description

Laparoscopic cholecystectomy is preferred surgical treatment for symptomatic gallstones .laparscopic procedure is superior to open procedue .the incidence of gallbladder perforation and spillage of bile and gallstones has been found as high as 40% .complications and management of gall bladder perforation and spillage of gallstones and bile

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Our purpose was to report the occurrence of complications following spilled gallstones during laparoscopic cholecystectomy at assiut university Hospital	Complications of intraoperative spilled gallstones and bile in laparoscopic cholecystectomy (inta abdominal abscess and localized bile collection ) and follow up for late complications	Follow up complication for 6 months postoperative by abdominal ultrasound and multiple slice ct abdomen if needed

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all age groups
only laparoscopic cholecystectomy
all types ,numbers and sizes os gall stones

Exclusion Criteria:

open cholecystectomh
patient refuse to enrol this study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Results from intraoperative spillage of bile and gallstones intra abdomen during laparascopic cholecystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omar mohamed Ahmed Mohamed	Contact	00201022533837		Omarmakhlof1993@gmail.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis
D042882	Gallstones

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D002769	Cholelithiasis

Browse Leaves

Not provided

Browse Branches

Not provided