Cholecystitis, ChronicNCT04569370
A Scoring System for Difficult Laparoscopic Cholecystectomy
An observational study of Cholecystitis, Chronic, run by Assiut University.
Trial summary
Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease. Difficult laparoscopic cholecystectomy (LC) is the most common "difficult" surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cholecystitis, Chronic
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Nov 2021
- How long will I take part?
- 1 Month
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals
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
No sites are listed yet.
Besher Abo-el soud, Doctor contact
About this study
Official title: A Scoring System for Laparoscopic Cholycystectomy to Pick up Difficult Cases
Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease. Difficult laparoscopic cholecystectomy (LC) is the most common "difficult" surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a scoring system to avoid difficult 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 100 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
- Cholecystitis, Chronic
- Being tested
- Laparoscopic Cholecystectomy
- Medical subject headings
- Cholecystitis, Bronchiolitis Obliterans Syndrome
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 Factor | Intervention: Procedure: Laparoscopic cholecystectomy Receives: Procedure: Laparoscopic Cholecystectomy | |
| Difficult criteria | Intervention: Procedure: Laparoscopic cholecystectomy 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: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, ChronicStudies 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
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abobakr Mahfouz Abobakr, Assiut University
- Investigators
- Salah Ibrahim, Prof, Study director, Professor at faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569370
- Sponsor's protocol ID
- Scoring system for lap Choly
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Veerank N, Togale MD. VALIDATION OF A SCORING SYSTEM TO PREDICT DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY: A ONE-YEAR CROSS-SECTIONAL STUDY. J West Afr Coll Surg. 2018 Jan-Mar;8(1):23-39.
PubMed 30899702
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scoring System for Laparoscopic Cholycystectomy to Pick up Difficult Cases
- ClinicalTrials.gov ID
- NCT04569370
- Acronym / sponsor ID
- Scoring system for lap Choly
- Conditions
- Cholecystitis, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 29 Sep 2020 (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.
Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease. Difficult laparoscopic cholecystectomy (LC) is the most common "difficult" surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a scoring system to avoid difficult 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 100 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
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoring Factor | – | Procedure: Laparoscopic CholecystectomyIntervention: Procedure: Laparoscopic cholecystectomy |
| Difficult criteria | – | Procedure: Laparoscopic CholecystectomyIntervention: Procedure: Laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals
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 | Difficult criteria, Scoring Factor |
Primary outcome
Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy
Time frame: 1 year
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 29 Sep 2020.
- Background: PubMed 30899702Veerank N, Togale MD. VALIDATION OF A SCORING SYSTEM TO PREDICT DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY: A ONE-YEAR CROSS-SECTIONAL STUDY. J West Afr Coll Surg. 2018 Jan-Mar;8(1):23-39.
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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.
Besher Abo-el soud, Doctor contact
Salah Ibrahim, Prof study director
Professor at faculty of medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Chronic, run by Assiut University.
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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Abobakr Mahfouz Abobakr, Resident (00201066336030 ext. 00201554228866, karemmahfouz99@yahoo.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: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569370, which also lists 1 linked publication.
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 29 Sep 2020.