Abdominal DisorderNCT06317779
Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair
An observational study of Abdominal Disorder, run by Assiut University.
Trial summary
Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy. Read more about this study
- Who is it for?
- Ages 10 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Disorder
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia
Who may be able to join
- Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia
Who cannot join
- Patients with associated diseases such as chronic pulmonary disease, cardiac disease, chronic renal failure.
- patients with strangulated para-umbilical hernia
- patients with recurrent paraumbilical hernia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy.
Read the detailed description
Laparoscopy is a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin.
The use of laparoscopy in abdominal surgeries increases for its great benefits over open surgery as:
1)faster recovery, 2)shorter hospital stays 3)decrease blood loss, 4)decreased postoperative pain 5)earlier return to work and resumption of normal daily activity as well as, 6)cosmetic benefits. few studies discuss the efficacy and safety of using Laparoscopy in management of lap cholecyctectomy and concomitant paraumbilical hernia repair
- Conditions
- Abdominal Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair
the incidence of recurrence of hernia
Measured: Baseline
Secondary outcomes (1)
Secondary outcomes measures
Decrease duration of operation by doing two by hours minutes operation at same session
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal DisorderStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Mohamed Fazary, Assiut University
- Investigators
- Ahmed M Ali, Study director, General surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317779
- Sponsor's protocol ID
- abdominal laparotomy
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair
- ClinicalTrials.gov ID
- NCT06317779
- Acronym / sponsor ID
- abdominal laparotomy
- Conditions
- Abdominal Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Mar 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.
Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy.
Detailed description
Laparoscopy is a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin.
The use of laparoscopy in abdominal surgeries increases for its great benefits over open surgery as:
1)faster recovery, 2)shorter hospital stays 3)decrease blood loss, 4)decreased postoperative pain 5)earlier return to work and resumption of normal daily activity as well as, 6)cosmetic benefits. few studies discuss the efficacy and safety of using Laparoscopy in management of lap cholecyctectomy and concomitant paraumbilical hernia repair
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia
Key inclusion criteria (1 listed)
- Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia
Key exclusion criteria (3 listed)
- Patients with associated diseases such as chronic pulmonary disease, cardiac disease, chronic renal failure.
- patients with strangulated para-umbilical hernia
- patients with recurrent paraumbilical hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair
Time frame: Baseline
the incidence of recurrence of hernia
1 secondary outcome
Secondary outcomes measures
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Ahmed M Ali study director
General surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Disorder, 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moustafa M Fazary (01021790211, mm0982429@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair (time frame: Baseline). 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 19 Mar 2024.