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CompletedNCT04329143Updated Apr 3, 2020

Post-Cholecystectomy Gall Bladder Remnant and Cystic Duct Stump Stone

An interventional study of open completion cholecystectomy and lap completion cholecystectomy in Laparocele, sponsored by Zagazig University. Completed. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-04-03.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 2 months after the study started (first participant enrolled Jan 2013, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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...

Read the detailed description

The incidence of gall bladder and cystic duct stump stones has been reported to be 5% of patients after urgent cholecystectomy, and it is rare after elective operations . The incidence of incomplete gallbladder removal following laparoscopic cholecystectomy is 13.3% . Partial cholecystectomy may be resorted to in many conditions such as difficult dissection in Calot's triangle that can be hazardous to common bile duct and/or blood vessels. In such cases, many surgeons leave a part of the gall bladder in the manner described by author after removing all stones from the remaining cuff of the gallbladder To prevent the incidence of gallbladder remnant/cystic duct stump calculi, the cystic duct should be fully skeletonized till 1 cm from the common bile duct. Stones in the cystic duct should be milked back to the gallbladder before clipping Routine use of intraoperative cholangiography is not a must but when used it can be useful in detecting calculi in the cystic duct The diagnosis of cystic duct stump syndrome is always into the dilemma of post cholecystectomy syndromes and leads to delayed diagnosis. Cystic duct stump syndrome may be misdiagnosed with reflux esophagitis, peptic ulceration, irritable bowel syndrome or chronic pancreatitis hepatitis, mesenteric ischemia, diverticulitis, and organic or motor intestinal disorders.

The imaging approach to post cholecystectomy syndrome includes ultrasonography, computed tomography (CT) scan, endoscopic retrograde cholangiopancreatography (ERCP), and magnetic resonance cholangiopancreatography (MRCP).

The purpose of this study is to emphasis that laparoscopic completion cholecystectomy is the best surgical option for cystic duct stump and gall bladder remnant syndrome as regard safety to the patients...

There may be gender specific risk factor for developing post-cholecystectomy syndrome, in present study; the incidence was 70% in females (14 cases) compared to 30% in males (6 cases). This higher incidence in females was also reported , whom stated that the male to female ratio was 1:1.45.

The symptoms of gall bladder syndrome may be nil or they can present with acute symptoms (biliary colic, acute cholecystitis or acute pancreatitis) or chronic symptoms (persistent right upper quadrant discomfort or pain, food intolerance, nausea or jaundice). The persistence of symptoms after cholecystectomy points to the possibility of a gallbladder remnant, especially when coupled with radiation of pain to the shoulder, food intolerance, nausea or jaundice . abdominal pain and persistent dyspepsia as the commonest presentation were stated by other study , while , reported that patients was referred to their institution without persistent symptoms after cholecystectomy .In the present study, most cases presented with right hypochondrial pain (18 cases) and asymptomatic cases are 2 cases and discovered accidently by ultrasonography for other unrelated symptoms.

02

Conditions studied

  • Laparocele

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Keywords

  • Post cholecystectomy
  • Stump
  • stone
03

In context

Calculi

51 studies on the registry are indexed under Calculi; 6 are open to participants now.

This study's enrollment of 2 is below the median of 74 across 43 interventional studies indexed under Calculi.

Browse Calculi studies →

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Age: 30-50

      • Both sex
      • Previous cholecystectomy(open or laparoscopic)
      • With or without common bile duct stone.
      • Symptomatic or

Exclusion criteria

Exclusion Criteria:

    • 1-patients unfit for surgery

      • 2-patient refused surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2 participants (actual)

Study arms

  • Active comparator
    open completion cholecystectomy

    open completion cholecystectomy for cystic duct stump stone

    Procedure: open completion cholecystectomy

  • Active comparator
    laparoscopic completion cholecystectomy

    lap completion cholecystectomy for cystic duct stump stone

    Procedure: lap completion cholecystectomy

Interventions

  • Procedureopen completion cholecystectomy

    open excision of cystic duct remnant

  • Procedurelap completion cholecystectomy

    lap excision of cystic duct stone

06

What researchers measure

Primary outcomes

  1. postoperative pain severity on visual analogue score

    assessement of pain severity after operation in record of 10

    Time frame: 2 weeks

Secondary outcomes

  1. intraoperative time in minutes

    assessement of time in the operation in minutes

    Time frame: 2 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2013 to primary completion in Jan 2018, 60 months.

Of 16 interventional studies with no phase under Calculi, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 60. This study's 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2020
First posted
Apr 1, 2020
StartActual
Jan 1, 2013
Primary completionActual
Jan 1, 2018
CompletionActual
Jan 1, 2020
Last update
Apr 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04329143
Lead sponsor
Zagazig University
Responsible party
Tamer Alsaied Alnaimy (assistant professour, Zagazig University) — Principal investigator
First posted
Apr 1, 2020
Start date
Jan 1, 2013
Primary completion
Jan 1, 2018
Completion
Jan 1, 2020
Last update
Apr 3, 2020

Study contacts

tamer A. alnaimy, MD
principal investigator · Zagazig University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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