LaparoceleNCT04329143
Post-Cholecystectomy Gall Bladder Remnant and Cystic Duct Stump Stone
A study testing open completion cholecystectomy and lap completion cholecystectomy in people with Laparocele, run by Zagazig University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Laparocele
- What is being tested?
- open completion cholecystectomy and lap completion cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jan 2020
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Age: 30-50
- Both sex
- Previous cholecystectomy(open or laparoscopic)
- With or without common bile duct stone.
- Symptomatic or
Who cannot join
- • 1-patients unfit for surgery
- 2-patient refused surgery.
About this study
Official title: Post-Cholecystectomy Gall Bladder Remnant and Cystic Duct Stump Stone: Surgical Pitfalls, Causes of Occurrence and Completion Cholecystectomy (Open Vs Laparoscopic) as a Safe Surgical Option of Treatment
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.
- Conditions
- Laparocele
- Being tested
- open completion cholecystectomy, lap completion cholecystectomy
- Keywords
- Post cholecystectomy, Stump, stone
- Medical subject headings
- Postcholecystectomy Syndrome, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open completion cholecystectomyProcedure or surgery
open excision of cystic duct remnant
lap completion cholecystectomyProcedure or surgery
lap excision of cystic duct stone
| Study group | Role | What they receive |
|---|---|---|
| open completion cholecystectomy | Active comparator | open completion cholecystectomy for cystic duct stump stone Receives: Procedure: open completion cholecystectomy |
| laparoscopic completion cholecystectomy | Active comparator | lap completion cholecystectomy for cystic duct stump stone Receives: Procedure: lap completion cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain severity on visual analogue score
assessement of pain severity after operation in record of 10
Measured: 2 weeks
Secondary outcomes (1)
intraoperative time in minutes
assessement of time in the operation in minutes
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Jan 2013
- Primary completion1 Jan 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoceleStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer Alsaied Alnaimy, Zagazig University
- Investigators
- tamer A. alnaimy, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329143
- Sponsor's protocol ID
- cystic duct stump stone
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Cholecystectomy Gall Bladder Remnant and Cystic Duct Stump Stone: Surgical Pitfalls, Causes of Occurrence and Completion Cholecystectomy (Open Vs Laparoscopic) as a Safe Surgical Option of Treatment
- ClinicalTrials.gov ID
- NCT04329143
- Acronym / sponsor ID
- cystic duct stump stone
- Conditions
- Laparocele
- Keywords
- Post cholecystectomy, Stump, stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 1 Apr 2020 (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.
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...
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open completion cholecystectomy | Active comparator | Procedure: open completion cholecystectomyopen completion cholecystectomy for cystic duct stump stone |
| laparoscopic completion cholecystectomy | Active comparator | Procedure: lap completion cholecystectomylap completion cholecystectomy for cystic duct stump stone |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Age: 30-50
Key exclusion criteria (2 listed)
- • 1-patients unfit for surgery
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 |
|---|---|---|
| open completion cholecystectomyopen excision of cystic duct remnant | Procedure or surgery | open completion cholecystectomy |
| lap completion cholecystectomylap excision of cystic duct stone | Procedure or surgery | laparoscopic completion cholecystectomy |
Primary outcome
postoperative pain severity on visual analogue score
Time frame: 2 weeks
assessement of pain severity after operation in record of 10
1 secondary outcome
intraoperative time in minutes
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: No
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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.
tamer A. alnaimy, MD principal investigator
Zagazig University
Questions about this trial
What is this clinical trial studying?
A study testing open completion cholecystectomy and lap completion cholecystectomy in people with Laparocele, run by Zagazig 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 3 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative pain severity on visual analogue score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2020.