Intraoperative Spillage of Bile and Gallstones During Laparoscopic Cholecysetectomy

July 30, 2019 updated by: Omar mohamed ahmed mohamed, Assiut University
  1. determine the most important factors which is responsible for the outcome post bile and gallstones spillage during laparoscopic cholecystectomy
  2. the management of complications of bile and gallstones spillage

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Our purpose was to report the occurrence of complications following spilled gallstones during laparoscopic cholecystectomy at assiut university Hospital
Time Frame: Follow up complication for 6 months postoperative by abdominal ultrasound and multiple slice ct abdomen if needed
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

July 27, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bile spillage intraoperative

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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