NCT04041726

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Status
unknown

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

First Submitted

Initial submission to the registry

July 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 27, 2019

Last Update Submit

July 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • open cholecystectomh
  • patient refuse to enrol this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CholecystitisGallstones

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisCholecystolithiasisCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Omar mohamed Ahmed Mohamed

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at general surgery department

Study Record Dates

First Submitted

July 27, 2019

First Posted

August 1, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

August 1, 2019

Record last verified: 2019-07