Evaluation StudiesNCT03718572
Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy
An observational study of Evaluation Studies, run by Assiut University at 1 site in Egypt.
Trial summary
Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluation Studies
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults male and female age of or above 18 years
Who may be able to join
- Adults male and female age of or above 18 years
- Symptomatic chronic calculous cholecystitis
- Ultrasound confirmed Gall bladder stones
Who cannot join
- Complicated chronic calculous cholecystitis
- Malignant Gall bladder
Trial locations and contacts
1 site in 1 country.
About this study
Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy.
Read the detailed description
Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 30 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.
- Conditions
- Evaluation Studies
- Being tested
- Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Surgical removal of Gall bladder using laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| Scoring factors | Not described Receives: Procedure: Laparoscopic cholecystectomy | |
| Difficulty criteria | Not described Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy
Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation StudiesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElRhman Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718572
- Sponsor's protocol ID
- AssiutU1001
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03718572
- Acronym / sponsor ID
- AssiutU1001
- Conditions
- Evaluation Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy.
Detailed description
Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 30 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoring factors | – | Procedure: Laparoscopic cholecystectomy |
| Difficulty criteria | – | Procedure: Laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults male and female age of or above 18 years
Key inclusion criteria (3 listed)
- Adults male and female age of or above 18 years
- Symptomatic chronic calculous cholecystitis
- Ultrasound confirmed Gall bladder stones
Key exclusion criteria (2 listed)
- Complicated chronic calculous cholecystitis
- Malignant Gall bladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomySurgical removal of Gall bladder using laparoscopy | Procedure or surgery | Difficulty criteria, Scoring factors |
Primary outcome
Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy
Time frame: 6 monthes
Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation Studies, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AbdElRhman Mohamed, Dr (0201065787845, elabassi1001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy (time frame: 6 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.