Gallstone DiseaseNCT01583348
Technical Feasibility of Routine Intraoperative Cholangiography During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy
An observational study of Gallstone Disease, run by Cantonal Hospital, Baselland at 1 site in Switzerland.
Trial summary
While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gallstone Disease
- What is being tested?
- Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Apr 2013
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with symptomatic gallstone disease with an indication for elective cholecystectomy
Who may be able to join
- symptomatic gallstone disease
- age > 18 years
- written informed consent
Who cannot join
- age < 18 years
- not able to understand informed consent
- pregnancy
- vaginal atresia
- florid vaginal infection
- gynecological neoplasia
Show all 9Show fewer
- allergy to Iod
- missing informed consents
- emergency procedure
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cantonal Hospital Baselland, Bruderholz, Department of Surgery
Bruderholz, Basel-Landschaft, 4101
About this study
Official title: An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)
While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.
- Conditions
- Gallstone Disease
- Being tested
- Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy
- Keywords
- transvaginal, NOTES, cholecystectomy, cholangiography, symptomatic gallstone disease
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomyProcedure or surgery
During transvaginal rigid-hybrid NOTES cholecystectomy a intraoperative cholangiography is performed. After dissection of the Calot's triangle and distal clipping of the cystic duct, the cystic duct is incised and a regular cholangiography catheter is inserted. Contrast is injected and an image is obtained using an image-converter. After extraction of the catheter the cystic duct is clipped proximally. This intervention is performed in all patients included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Women with gallstones | 30 women with symptomatic gallstone disease with an indication for elective cholecystectomy Receives: Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)
Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.
Measured: intraoperative
Secondary outcomes (3)
Time required for cholangiography
From incision of the cystic duct to clipping of the cystic duct
Measured: intraoperative
Intraoperative complications
Measured: intraoperative
postoperative complications
Measured: within 6 weeks from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstone DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Steinemann, MD, Cantonal Hospital, Baselland
- Investigators
- Andreas Zerz, MD, Study chair, Cantonal Hospital Baselland, Department of Surgery, Bruderholz, SwitzerlandDaniel C Steinemann, MD, Principal investigator, Cantonal Hospital Baselland, Department of Surgery, Bruderholz, SwitzerlandÖnder Ögredici, MD, Principal investigator, Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583348
- Sponsor's protocol ID
- 45/12
- Status last verified
- Apr 2013
- First submitted
- 20 Apr 2012
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)
- ClinicalTrials.gov ID
- NCT01583348
- Acronym / sponsor ID
- 45/12
- Conditions
- Gallstone Disease
- Keywords
- transvaginal, NOTES, cholecystectomy, cholangiography, symptomatic gallstone disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Apr 2012 (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.
While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with gallstones | – | Procedure: Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy30 women with symptomatic gallstone disease with an indication for elective cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with symptomatic gallstone disease with an indication for elective cholecystectomy
Key inclusion criteria (3 listed)
- symptomatic gallstone disease
- age > 18 years
- written informed consent
Key exclusion criteria (9 listed)
- age < 18 years
- not able to understand informed consent
- pregnancy
- vaginal atresia
- florid vaginal infection
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 |
|---|---|---|
| Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomyDuring transvaginal rigid-hybrid NOTES cholecystectomy a intraoperative cholangiography is performed. After dissection of the Calot's triangle and distal clipping of the cystic duct, the cystic duct is incised and a regular cholangiography catheter is inserted. Contrast is injected and an image is obtained using an image-converter. After extraction of the catheter the cystic duct is clipped proximally. This intervention is performed in all patients included in the study. | Procedure or surgery | Women with gallstones |
Primary outcome
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)
Time frame: intraoperative
Was the introduction of the cholangiography catheter into the cystic duct successfull during transvaginal rigid-hybrid cholecystectomy.
3 secondary outcomes
Time required for cholangiography
Time frame: intraoperative
Intraoperative complications
Time frame: intraoperative
postoperative complications
Time frame: within 6 weeks from surgery
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 30 Apr 2013.
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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.
Andreas Zerz, MD study chair
Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
Daniel C Steinemann, MD principal investigator
Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
Önder Ögredici, MD principal investigator
Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone Disease, run by Cantonal Hospital, Baselland at 1 site in Switzerland.
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 9 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 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
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?
Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no) (time frame: intraoperative). 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 30 Apr 2013.