NCT04329143

Brief Summary

Introduction: cholecystectomy relieves pre-surgical symptoms of gallbladder disease. The persistence of symptoms was recorded in 10 - 20% of cases. Residual gall bladder/cystic duct stump stone is one of the most important cause. Aim: to compare between open and laparoscopic completion cholecystectomy of gall bladder remnant and cystic duct stump syndrome as regard short and long term outcome. Methods: This prospective study was conducted on 20 cases with residual GB/cystic duct stump stone. The diagnosis was guided by ultrasound and magnetic resonance cholangio-pancreatography. All cases were managed by using completion cholecystectomy - either open or laparoscopic. All preoperative, operative, and postoperative data were collected...

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

March 30, 2020

Last Update Submit

March 31, 2020

Conditions

Laparocele

Keywords

Post cholecystectomyStumpstone

Outcome Measures

Primary Outcomes (1)

  • postoperative pain severity on visual analogue score

    assessement of pain severity after operation in record of 10

    2 weeks

Secondary Outcomes (1)

  • intraoperative time in minutes

    2 hours

Study Arms (2)

open completion cholecystectomy

ACTIVE COMPARATOR

open completion cholecystectomy for cystic duct stump stone

Procedure: open completion cholecystectomy

laparoscopic completion cholecystectomy

ACTIVE COMPARATOR

lap completion cholecystectomy for cystic duct stump stone

Procedure: lap completion cholecystectomy

Interventions

open completion cholecystectomyPROCEDURE

open excision of cystic duct remnant

open completion cholecystectomy
lap completion cholecystectomyPROCEDURE

lap excision of cystic duct stone

laparoscopic completion cholecystectomy

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 30-50
  • Both sex
  • Previous cholecystectomy(open or laparoscopic)
  • With or without common bile duct stone.
  • Symptomatic or

You may not qualify if:

  • 1-patients unfit for surgery
  • patient refused surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postcholecystectomy SyndromeCalculi

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Officials

  • tamer A. alnaimy, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professour

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

January 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2020

Last Updated

April 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share