NCT06048029

Brief 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 incidence of childhood gall stones.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 3, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 15, 2023

Last Update Submit

September 15, 2023

Conditions

Laparoscopic Cholecystectomy in Children

Outcome Measures

Primary Outcomes (1)

  • Cholecystectomy in children

    Evaluate and the risk factors for conversion of laparoscopic to open cholecystectomy

    one year

Study Arms (2)

Laparoscopic Cholecystectomy in children

OTHER

Evaluate preoperative and operative risk factors for laparoscopic cholecystectomy compared to open cholecystetcomy

Procedure: laparscopic Cholecystectomy in children

Open Cholecystectomy in children

OTHER

Evaluate preoperative and operative risk factors for open cholecystectomy compared to laparoscopic cholecystetcomy

Procedure: laparscopic Cholecystectomy in children

Interventions

laparscopic Cholecystectomy in childrenPROCEDURE

Evaluate preoperative and operative risk factors for conversion of laparoscopic cholecystectomy to open cholecystectomy

Also known as: open Cholecystectomy in children
Laparoscopic Cholecystectomy in childrenOpen Cholecystectomy in children

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with age less than 18 years old presented to assiut university hospitals at pediatric surgeey unit.
  • fit for surgery

You may not qualify if:

  • patients with co-existent common bile duct stones based on imaging and biochemical criteria.
  • Patients with Pancreatitis .
  • Patients with previous upper abdominal surgery.
  • \_Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Chronic Pulmonary Disease, significant Cardiac Disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 10987028BACKGROUND

  • van 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.

    PMID: 22108744BACKGROUND

  • Rothstein 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.

    PMID: 27521713BACKGROUND

  • Khoo 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.

    PMID: 24528968BACKGROUND

  • Zeidan 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.

    PMID: 24887542BACKGROUND

  • Palser 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.

    PMID: 29368285BACKGROUND

  • Padbury RTA. Day-only laparoscopic cholecystectomy in 2021. ANZ J Surg. 2021 Apr;91(4):484. doi: 10.1111/ans.16686. No abstract available.

    PMID: 33847061BACKGROUND

  • Rio-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.

    PMID: 34386554BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
primary investigator

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

December 3, 2023

Primary Completion

December 10, 2024

Study Completion

December 10, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09