GallstonesPhase 2NCT02947256
Laparoscopic Cholecystectomy With Retro-infundibular Approach
A Phase 2 study testing standard laparoscopic cholecystectomy and RI approach in people with Gallstones, run by Minia University at 2 sites in Egypt.
Trial summary
Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred chole-cystohepatic (Calot's) triangle. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gallstones
- What is being tested?
- standard laparoscopic cholecystectomy and RI approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesEgypt
- Study dates
- Jul 2013to Jan 2016
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with gallstones
- score difficulty according to Gupta et al 2013 > 6
- patient fit for laparoscopic surgery
Who cannot join
- score difficulty according to Gupta et al 2013 > 6
- patient unfit for laparoscopic surgery
- refusal to share in the study
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine
Minya, 61511
Minia University Hospital
Minya, 61511
About this study
Official title: Laparoscopic Cholecystectomy With Retro-infundibular Approach Versus Standard Laparoscopic Cholecystectomy in Difficult Cases, Where Calot's Triangle is Unsafe to be Dissected
Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred chole-cystohepatic (Calot's) triangle.
Read the detailed description
This study is a prospective cohort study, conducted in Minia university hospital and Minia insurance hospital in the period from July 2013 to January 2016, where 597 patients with gallstones were admitted for laparoscopic cholecystectomy and were done by the same surgeon. Based on the preoperative scoring system to predict the degree of difficulty in laparoscopic cholecystectomy, patients that had the score > 6 and were fit for laparoscopic surgery were included in the study. Only 125 met these criteria and agreed to share in the study and gave their informed consent. 60 patients were operated by SLC (Group 1).This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery. While, 65 patients were operated by laparoscopic cholecystectomy using RI approach (Group 2). This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
Operative procedure of by RI approach:
The site of trocars was the same as for the standard cholecystectomy. After dissection of adhesion masking the GB, if present, to reach the Hartmann pouch, at this point Calot's triangle usually was scarred and frozen, the surgeon never tried to dissect it and instead the surgeon continued as follow :
- De-shouldering of GB: by incising the serosal covering on either side of the infundibulum and lower part of the body.
- This followed by dissection and separation of the lower third of GB body from its bed, using suction-irrigation probe or hook dissector. Dissection continued downward till the GB pedicle (duct and artery).
- Mass ligation of cystic artery and duct, using intracorporeal note by vicryl number 1 suture.
- Then the surgeon cut above the ligature using diathermy on scissor or ultrasound sealing device. During this step the cut end of the GB was grasped by forceps trying to prevent spillage of its content, if happened, stones were collected in a bag and extracted.
- Then GB was dissected from its bed as usual and extracted in a bag. In cases where the GB was hugely distended, it was aspirated firstly to facilitate its grasping. Also in cases of Mirizzi syndrome the GB was opened direct on the stone to remove it, to facilitate grasping of GB then we continued as described above
- Conditions
- Gallstones
- Being tested
- standard laparoscopic cholecystectomy, RI approach
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard laparoscopic cholecystectomyProcedure or surgery
Also called SLC
which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery
RI approachProcedure or surgery
which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
| Study group | Role | What they receive |
|---|---|---|
| standard laparoscopic cholecystectomy | Active comparator | This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery. Receives: Procedure: standard laparoscopic cholecystectomy |
| RI approach | Experimental | Retroinfundibular laparoscopic cholecystectomy: This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
Operative procedure of by RI approach: Receives: Procedure: RI approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion to open
the incidence of conversion to open
Measured: 24 hours
biliary injury
the incidence of biliary injury
Measured: 2 weeks
Secondary outcomes (3)
operative time
time from skin opening to skin closure
Measured: 24 hours
hospital stay
time of hospital stay
Measured: 6 weeks
mortality
incidence of operative related mortality
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJul 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstonesStudies of the same condition, open and under way.
- More trials run by Minia 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
- Investigators
- Alaa M Sewefy, MD, Principal investigator, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947256
- Sponsor's protocol ID
- fac.med.011
- Status last verified
- Oct 2016
- First submitted
- 22 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Cholecystectomy With Retro-infundibular Approach Versus Standard Laparoscopic Cholecystectomy in Difficult Cases, Where Calot's Triangle is Unsafe to be Dissected
- ClinicalTrials.gov ID
- NCT02947256
- Acronym / sponsor ID
- fac.med.011
- Conditions
- Gallstones
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Oct 2016 (estimated)
- 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.
Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred chole-cystohepatic (Calot's) triangle.
Detailed description
This study is a prospective cohort study, conducted in Minia university hospital and Minia insurance hospital in the period from July 2013 to January 2016, where 597 patients with gallstones were admitted for laparoscopic cholecystectomy and were done by the same surgeon. Based on the preoperative scoring system to predict the degree of difficulty in laparoscopic cholecystectomy, patients that had the score > 6 and were fit for laparoscopic surgery were included in the study. Only 125 met these criteria and agreed to share in the study and gave their informed consent. 60 patients were operated by SLC (Group 1).This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery. While, 65 patients were operated by laparoscopic cholecystectomy using RI approach (Group 2). This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
Operative procedure of by RI approach:
The site of trocars was the same as for the standard cholecystectomy. After dissection of adhesion masking the GB, if present, to reach the Hartmann pouch, at this point Calot's triangle usually was scarred and frozen, the surgeon never tried to dissect it and instead the surgeon continued as follow :
- De-shouldering of GB: by incising the serosal covering on either side of the infundibulum and lower part of the body.
- This followed by dissection and separation of the lower third of GB body from its bed, using suction-irrigation probe or hook dissector. Dissection continued downward till the GB pedicle (duct and artery).
- Mass ligation of cystic artery and duct, using intracorporeal note by vicryl number 1 suture.
- Then the surgeon cut above the ligature using diathermy on scissor or ultrasound sealing device. During this step the cut end of the GB was grasped by forceps trying to prevent spillage of its content, if happened, stones were collected in a bag and extracted.
- Then GB was dissected from its bed as usual and extracted in a bag. In cases where the GB was hugely distended, it was aspirated firstly to facilitate its grasping. Also in cases of Mirizzi syndrome the GB was opened direct on the stone to remove it, to facilitate grasping of GB then we continued as described above
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard laparoscopic cholecystectomy | Active comparator | Procedure: standard laparoscopic cholecystectomyThis included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery. |
| RI approach | Experimental | Procedure: RI approachRetroinfundibular laparoscopic cholecystectomy: This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both. Operative procedure of by RI approach: |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient with gallstones
- score difficulty according to Gupta et al 2013 > 6
- patient fit for laparoscopic surgery
Key exclusion criteria (3 listed)
- score difficulty according to Gupta et al 2013 > 6
- patient unfit for laparoscopic surgery
- refusal to share in the study
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 |
|---|---|---|
| standard laparoscopic cholecystectomyAlso: SLCwhich included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery | Procedure or surgery | standard laparoscopic cholecystectomy |
| RI approachwhich included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both. | Procedure or surgery | RI approach |
Primary outcome
conversion to open
Time frame: 24 hours
the incidence of conversion to open
biliary injury
Time frame: 2 weeks
the incidence of biliary injury
3 secondary outcomes
operative time
Time frame: 24 hours
hospital stay
Time frame: 6 weeks
mortality
Time frame: 6 weeks
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 1 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Gallstones
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
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.
Alaa M Sewefy, MD principal investigator
Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing standard laparoscopic cholecystectomy and RI approach in people with Gallstones, run by Minia University at 2 sites in Egypt.
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 3 inclusion and 3 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
conversion to open (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 1 Nov 2016.