Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .

NCT ID: NCT06048029

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-03
• Study Completion Date: 2025-12-10

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Cholecystectomy in children

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

Group Type: OTHER

laparscopic Cholecystectomy in children

Intervention Type: PROCEDURE

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

Open Cholecystectomy in children

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

Group Type: OTHER

laparscopic Cholecystectomy in children

Intervention Type: PROCEDURE

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

Interventions

laparscopic Cholecystectomy in children

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

Intervention Type: PROCEDURE

Other Intervention Names

open Cholecystectomy in children

Eligibility Criteria

Inclusion Criteria

1. Patients with age less than 18 years old presented to assiut university hospitals at pediatric surgeey unit.

2. fit for surgery

Exclusion Criteria

1. patients with co-existent common bile duct stones based on imaging and biochemical criteria.

2. Patients with Pancreatitis .

3. Patients with previous upper abdominal surgery.

5_Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Chronic Pulmonary Disease, significant Cardiac Disease)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mohamed Korashy

primary investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 10987028 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22108744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27521713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24528968 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24887542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29368285 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 33847061 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34386554 (View on PubMed)

Other Identifiers

Cholecystectomy

Identifier Type: -

Identifier Source: org_study_id