Cholecystitis, ChronicNCT06264115
Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience
An observational study of Cholecystitis, Chronic, run by Sohag University at 1 site in Egypt.
Trial summary
To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis, Chronic
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergoing laparoscopic cholecystectomy
Who may be able to join
- Age 18 to 75 years.
- Both sexes.
- Patient with clinical, laboratory and/or radiological evidence that is a candidate for cholecystectomy operation.
Who cannot join
- Patient's refusal.
- Bile duct stones.
- History of obstructive jaundice.
- Severe acute calculus pancreatitis.
- Severe co-morbid diseases (uncontrolled diabetes, hypertension, and severe direct hyperbilirubinemia).
- Prior surgery or adhesion.
Show all 9Show fewer
- Radical cholecystectomy.
- Pregnancy.
- Malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy
Read the detailed description
To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy Randomized clinical trial comparative study will be carried out on 50 patients underwent laparoscopic cholecystectomy in general surgical department, Sohag University. An informed written consent will be obtained from the patients. Every patient will receive an explanation of the purpose of the study and will have a secret code number. Research results will be only used for scientific purposes. Any unexpected risks appearing during the course of research will be clarified to the participants and to the ethical committee on time.
Patients will be randomly classified into two equal groups; 25 patients will be enrolled in each group using computer generated random number in closed sealed envelope.
Group I (3-ports): 25 patients undergo a three-port LC. Group II (4-ports): 25 patients undergo a four-port LC. All patients will be subjected to thorough history taking (age, sex, symptoms, and duration of symptoms) and full clinical evaluation.
Abdominal ultrasound will be done in all patients. Baseline laboratory (complete blood count and coagulation profile) will be ordered in all patients.
- 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
Using Three Ports or Four Ports for Laparoscopic Cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Three ports Laparoscopic Cholecystectomy group | Not described Receives: Procedure: Laparoscopic Cholecystectomy | |
| Four ports Laparoscopic Cholecystectomy group | Not described Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Measurement of postoperative pain in both groups according to visual analogue scale The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Measured: One year
Secondary outcomes (2)
Operative time
Measured: One year
length of hospital stay
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, ChronicStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikel Mokhtar Shafik, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264115
- Sponsor's protocol ID
- Soh-Med-24-01-05MS
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience
- ClinicalTrials.gov ID
- NCT06264115
- Acronym / sponsor ID
- Soh-Med-24-01-05MS
- Conditions
- Cholecystitis, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Feb 2024 (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.
To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy
Detailed description
To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy Randomized clinical trial comparative study will be carried out on 50 patients underwent laparoscopic cholecystectomy in general surgical department, Sohag University. An informed written consent will be obtained from the patients. Every patient will receive an explanation of the purpose of the study and will have a secret code number. Research results will be only used for scientific purposes. Any unexpected risks appearing during the course of research will be clarified to the participants and to the ethical committee on time.
Patients will be randomly classified into two equal groups; 25 patients will be enrolled in each group using computer generated random number in closed sealed envelope.
Group I (3-ports): 25 patients undergo a three-port LC. Group II (4-ports): 25 patients undergo a four-port LC. All patients will be subjected to thorough history taking (age, sex, symptoms, and duration of symptoms) and full clinical evaluation.
Abdominal ultrasound will be done in all patients. Baseline laboratory (complete blood count and coagulation profile) will be ordered in all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three ports Laparoscopic Cholecystectomy group | – | Procedure: Laparoscopic Cholecystectomy |
| Four ports Laparoscopic Cholecystectomy group | – | Procedure: Laparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing laparoscopic cholecystectomy
Key inclusion criteria (3 listed)
- Age 18 to 75 years.
- Both sexes.
- Patient with clinical, laboratory and/or radiological evidence that is a candidate for cholecystectomy operation.
Key exclusion criteria (9 listed)
- Patient's refusal.
- Bile duct stones.
- History of obstructive jaundice.
- Severe acute calculus pancreatitis.
- Severe co-morbid diseases (uncontrolled diabetes, hypertension, and severe direct hyperbilirubinemia).
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 CholecystectomyUsing Three Ports or Four Ports for Laparoscopic Cholecystectomy | Procedure or surgery | Four ports Laparoscopic Cholecystectomy group, Three ports Laparoscopic Cholecystectomy group |
Primary outcome
Postoperative pain score
Time frame: One year
Measurement of postoperative pain in both groups according to visual analogue scale The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
2 secondary outcomes
Operative time
Time frame: One year
length of hospital stay
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cholecystitis, Chronic, run by Sohag 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 9 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 20 Feb 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: One year). 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 20 Feb 2024.