Laparoscopic Cholecystectomy in ChildrenNCT06048029
Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .
A study testing laparscopic Cholecystectomy in children in people with Laparoscopic Cholecystectomy in Children, run by Assiut University.
Trial summary
Cholecystectomy is the most common procedure in biliary surgery which may be open or laparoscopic.laparoscopic cholecystectomy is widely accepted as the gold standard technique in both adults and children .over recent years there has been a significant increase in paediatric cholecystectomies alongside a rising… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy in Children
- What is being tested?
- laparscopic Cholecystectomy in children
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2023to 10 Dec 2025
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with age less than 18 years old presented to assiut university hospitals at pediatric surgeey unit.
- fit for surgery
Who cannot join
- patients with co-existent common bile duct stones based on imaging and biochemical criteria.
- Patients with Pancreatitis .
- Patients with previous upper abdominal surgery.
- 5Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Chronic Pulmonary Disease, significant Cardiac Disease)
About this study
Cholecystectomy is the most common procedure in biliary surgery which may be open or laparoscopic.laparoscopic cholecystectomy is widely accepted as the gold standard technique in both adults and children .over recent years there has been a significant increase in paediatric cholecystectomies alongside a rising incidence of childhood gall stones.
Read the detailed description
The majority of paediatric gallstones are related to haemolytic diseases such as hereditary spherocytosis. In recent decades, the incidence of gallstone disease in children has risen which may be related to the epidemic of paediatric obesity and improved survival of critically ill neonates who have received long-term total parenteral nutrition or correction of abnormalities resulting in increased incidence of cholelithiasis in the paediatric population such as short gut syndrome.The rate of conversion to open cholecystectomy ranges between 2% and 20%. Certain preoperative and operative factors can reliably predict the chances of conversion to the open procedure. Until recently large studies are lacking of assessment of the risk factors that my be responsible for conversion of laparoscopic cholecystectomy to open cholecystectomy . This study aims to assess preoperative and operative risk factors for conversion to open surgery .
- Conditions
- Laparoscopic Cholecystectomy in Children
- Being tested
- laparscopic Cholecystectomy in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparscopic Cholecystectomy in childrenProcedure or surgery
Also called open Cholecystectomy in children
Evaluate preoperative and operative risk factors for conversion of laparoscopic cholecystectomy to open cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Cholecystectomy in children | Other | Evaluate preoperative and operative risk factors for laparoscopic cholecystectomy compared to open cholecystetcomy Receives: Procedure: laparscopic Cholecystectomy in children |
| Open Cholecystectomy in children | Other | Evaluate preoperative and operative risk factors for open cholecystectomy compared to laparoscopic cholecystetcomy Receives: Procedure: laparscopic Cholecystectomy in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholecystectomy in children
Evaluate and the risk factors for conversion of laparoscopic to open cholecystectomy
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 posted21 Sep 2023
- Study start3 Dec 2023 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Cholecystectomy in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Korashy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048029
- Sponsor's protocol ID
- Cholecystectomy
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gadacz TR. Update on laparoscopic cholecystectomy, including a clinical pathway. Surg Clin North Am. 2000 Aug;80(4):1127-49. doi: 10.1016/s0039-6109(05)70217-6.
PubMed 10987028van der Steeg HJ, Alexander S, Houterman S, Slooter GD, Roumen RM. Risk factors for conversion during laparoscopic cholecystectomy - experiences from a general teaching hospital. Scand J Surg. 2011;100(3):169-73. doi: 10.1177/145749691110000306.
PubMed 22108744Rothstein DH, Harmon CM. Gallbladder disease in children. Semin Pediatr Surg. 2016 Aug;25(4):225-31. doi: 10.1053/j.sempedsurg.2016.05.005. Epub 2016 May 11.
PubMed 27521713Khoo AK, Cartwright R, Berry S, Davenport M. Cholecystectomy in English children: evidence of an epidemic (1997-2012). J Pediatr Surg. 2014 Feb;49(2):284-8; discussion 288. doi: 10.1016/j.jpedsurg.2013.11.053. Epub 2013 Nov 18.
PubMed 24528968Zeidan MM, Pandian TK, Ibrahim KA, Moir CR, Ishitani MB, Zarroug AE. Laparoscopic cholecystectomy in the pediatric population: a single-center experience. Surg Laparosc Endosc Percutan Tech. 2014 Jun;24(3):248-50. doi: 10.1097/SLE.0b013e3182a4c039.
PubMed 24887542Palser TR, Ceney A, Navarro A, Swift S, Bowrey DJ, Beckingham IJ. Variation in laparoscopic anti-reflux surgery across England: a 5-year review. Surg Endosc. 2018 Jul;32(7):3208-3214. doi: 10.1007/s00464-018-6038-y. Epub 2018 Jan 24.
PubMed 29368285Padbury RTA. Day-only laparoscopic cholecystectomy in 2021. ANZ J Surg. 2021 Apr;91(4):484. doi: 10.1111/ans.16686. No abstract available.
PubMed 33847061Rio-Tinto R, Canena J. Endoscopic Treatment of Post-Cholecystectomy Biliary Leaks. GE Port J Gastroenterol. 2021 Jul;28(4):265-273. doi: 10.1159/000511527. Epub 2020 Dec 8.
PubMed 34386554
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .
- ClinicalTrials.gov ID
- NCT06048029
- Acronym / sponsor ID
- Cholecystectomy
- Conditions
- Laparoscopic Cholecystectomy in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Dec 2023 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
Cholecystectomy is the most common procedure in biliary surgery which may be open or laparoscopic.laparoscopic cholecystectomy is widely accepted as the gold standard technique in both adults and children .over recent years there has been a significant increase in paediatric cholecystectomies alongside a rising incidence of childhood gall stones.
Detailed description
The majority of paediatric gallstones are related to haemolytic diseases such as hereditary spherocytosis. In recent decades, the incidence of gallstone disease in children has risen which may be related to the epidemic of paediatric obesity and improved survival of critically ill neonates who have received long-term total parenteral nutrition or correction of abnormalities resulting in increased incidence of cholelithiasis in the paediatric population such as short gut syndrome.The rate of conversion to open cholecystectomy ranges between 2% and 20%. Certain preoperative and operative factors can reliably predict the chances of conversion to the open procedure. Until recently large studies are lacking of assessment of the risk factors that my be responsible for conversion of laparoscopic cholecystectomy to open cholecystectomy . This study aims to assess preoperative and operative risk factors for conversion to open surgery .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Cholecystectomy in children | Other | Procedure: laparscopic Cholecystectomy in childrenEvaluate preoperative and operative risk factors for laparoscopic cholecystectomy compared to open cholecystetcomy |
| Open Cholecystectomy in children | Other | Procedure: laparscopic Cholecystectomy in childrenEvaluate preoperative and operative risk factors for open cholecystectomy compared to laparoscopic cholecystetcomy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with age less than 18 years old presented to assiut university hospitals at pediatric surgeey unit.
- fit for surgery
Key exclusion criteria (4 listed)
- patients with co-existent common bile duct stones based on imaging and biochemical criteria.
- Patients with Pancreatitis .
- Patients with previous upper abdominal surgery.
- 5Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Chronic Pulmonary Disease, significant Cardiac Disease)
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 |
|---|---|---|
| laparscopic Cholecystectomy in childrenAlso: open Cholecystectomy in childrenEvaluate preoperative and operative risk factors for conversion of laparoscopic cholecystectomy to open cholecystectomy | Procedure or surgery | Laparoscopic Cholecystectomy in children, Open Cholecystectomy in children |
Primary outcome
Cholecystectomy in children
Time frame: one year
Evaluate and the risk factors for conversion of laparoscopic to open cholecystectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 10987028Gadacz TR. Update on laparoscopic cholecystectomy, including a clinical pathway. Surg Clin North Am. 2000 Aug;80(4):1127-49. doi: 10.1016/s0039-6109(05)70217-6.
- Background: PubMed 22108744van der Steeg HJ, Alexander S, Houterman S, Slooter GD, Roumen RM. Risk factors for conversion during laparoscopic cholecystectomy - experiences from a general teaching hospital. Scand J Surg. 2011;100(3):169-73. doi: 10.1177/145749691110000306.
- Background: PubMed 27521713Rothstein DH, Harmon CM. Gallbladder disease in children. Semin Pediatr Surg. 2016 Aug;25(4):225-31. doi: 10.1053/j.sempedsurg.2016.05.005. Epub 2016 May 11.
- Background: PubMed 24528968Khoo AK, Cartwright R, Berry S, Davenport M. Cholecystectomy in English children: evidence of an epidemic (1997-2012). J Pediatr Surg. 2014 Feb;49(2):284-8; discussion 288. doi: 10.1016/j.jpedsurg.2013.11.053. Epub 2013 Nov 18.
- Background: PubMed 24887542Zeidan MM, Pandian TK, Ibrahim KA, Moir CR, Ishitani MB, Zarroug AE. Laparoscopic cholecystectomy in the pediatric population: a single-center experience. Surg Laparosc Endosc Percutan Tech. 2014 Jun;24(3):248-50. doi: 10.1097/SLE.0b013e3182a4c039.
- Background: PubMed 29368285Palser TR, Ceney A, Navarro A, Swift S, Bowrey DJ, Beckingham IJ. Variation in laparoscopic anti-reflux surgery across England: a 5-year review. Surg Endosc. 2018 Jul;32(7):3208-3214. doi: 10.1007/s00464-018-6038-y. Epub 2018 Jan 24.
- Background: PubMed 33847061Padbury RTA. Day-only laparoscopic cholecystectomy in 2021. ANZ J Surg. 2021 Apr;91(4):484. doi: 10.1111/ans.16686. No abstract available.
- Background: PubMed 34386554Rio-Tinto R, Canena J. Endoscopic Treatment of Post-Cholecystectomy Biliary Leaks. GE Port J Gastroenterol. 2021 Jul;28(4):265-273. doi: 10.1159/000511527. Epub 2020 Dec 8.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing laparscopic Cholecystectomy in children in people with Laparoscopic Cholecystectomy in Children, 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 2 inclusion and 4 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 21 Sep 2023. 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?
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?
Cholecystectomy in children (time frame: one 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 NCT06048029, which also lists 8 linked publications.
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 21 Sep 2023.