GallstonesTVCNCT01232959
Feasibility of Transvaginal Cholecystectomy
A study testing Transvaginal Cholecystectomy in people with Gallstones, run by Mayo Clinic.
Trial summary
Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. It is the current standard. It has replaced traditional open gallbladder surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gallstones
- What is being tested?
- Transvaginal Cholecystectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Dec 2012
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients undergoing elective cholecystectomy for cholelithiasis.
Who cannot join
- Male patients, patients <18 years or >65 years of age
- Pregnant patients
- Patients with prior pelvic surgery
- Patients with prior hepatobiliary surgery or other major abdominal surgery
- Patients with ASA class >3
- Patients with BMI >35
Show all 18Show fewer
- Patients with risk factors for requiring an open cholecystectomy (e.g. possible gallbladder cancer, acute cholecystitis, jaundice)
- Patients who cannot provide consent for the study
- Patients not willing to participate in the study.
- Patients with common bile duct stones
- Patients with evidence of abdominal abscess or mass
- Patients with diffuse peritonitis
- Patients with a clinical diagnosis of sepsis
- Patients with coagulopathy or using anticoagulants or anti-platelet agents (aspirin up to 81mg/day acceptable)
- Patients with planned concurrent procedures
- Patients with a prior diagnosis of intra-abdominal adhesions
- Patients who are participating in any other investigational device or drug trial that has not yet completed the primary endpoint
- Patients with an enlarged uterus
About this study
Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. It is the current standard. It has replaced traditional open gallbladder surgery. Open gallbladder surgery is done with a large incision. A new way of removing the gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This study is being done to see if removing the gallbladder through the vagina will work for patients at Mayo Clinic Rochester. This is the first step of this research to test the procedure. In the future, other studies will examine the potential for less scarring and reduced pain. In this study the investigators will still make small incisions in the abdomen, they will be smaller than the standard procedure but you will still have some scars on your abdomen.
Some very early research reports say that some patients may have less pain with the transvaginal approach; however, the investigators do not know if the transvaginal route will have any effect on your overall health and quality of life.
Read more
This study will evaluate:
- Effectiveness of the surgery: ability to remove the gallbladder safely
- Effect of the operation on your body: change in pulse and blood pressure during the surgery, level of inflammation markers in your blood before and after the surgery
- Recovery from surgery in the hospital: how much pain you have, how much pain medication you need, how long you need to stay in the hospital, or nature of any surgical complications (problems)
- Overall recovery from surgery: general quality of life, abdominal symptoms
What is the new type of surgery?
The new type of surgery is called transvaginal cholecystectomy:
A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.
Read the detailed description
As technologic innovations in medicine continue to advance, less intrusive operative procedures are being developed. Natural Orifice Transluminal Endoscopic Surgery (NOTES) may represent a less invasive approach to the abdominal cavity. The access to the abdominal cavity through natural orifices such as the vagina has the benefit of decreased somato-sensory innervation. This venue might confer less pain and operative stress to the patient. The transvaginal approach has been suggested as a new surgical approach to gallbladder surgery (cholecystectomy). Approximately 700 transvaginal cholecystectomy procedures have been performed in medical centers around the world so far. Anecdotal data suggest that the patients experience less pain postoperatively and half of them may not require any pain medication. Currently, introduction of this new operative approach outside of a research study is not supported by national nor international societies.
We wish to demonstrate that the transvaginal approach is feasible for 10 patients with gallstone disease at Mayo Clinic Rochester (MCR).
Methods: Female patients seen by consultants from the Division of General and Gastrointestinal Surgery, who have an appropriate indication for elective cholecystectomy, will be offered a cholecystectomy via the transvaginal approach. After patient enrollment, baseline demographics, questionnaires and blood draws will be obtained. The patient will undergo a laparoscopic assisted transvaginal cholecystectomy by a dedicated surgical team, consisting of a gynecologist, a minimally invasive surgeon and a gastroenterologist. This approach will utilize a 5-mm umbilical trocar and a posterior colpotomy. Standard laparoscopic and flexible endoscopic instrumentation will be utilized along with recently introduced long flexible-tip laparoscopic instrumentation to remove the gallbladder. Intraoperative parameters will be recorded. Postoperatively blood draws and questionnaires will be repeated at specific intervals.
Data analysis will be mainly descriptive for this feasibility study. The collected material will serve as pilot data for a future comparative study of transvaginal cholecystectomy with standard laparoscopic cholecystectomy.
- Conditions
- Gallstones
- Being tested
- Transvaginal Cholecystectomy
- Keywords
- Gallbladder removal
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal CholecystectomyDevice
Also called gallbladder removal
A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Surgery | Experimental | Gallbladder will be removed through the vagina Receives: Device: Transvaginal Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured by successful transvaginal removal of gallbladder
The procedure will be considered technically successful if at completion the cystic duct and artery have been clipped securely and the gallbladder has been removed through the transvaginal port. At the time of surgery, the procedure will be supervised with a laparoscope at all critical points. Conversion to a laparoscopic or open procedure is considered an incomplete transvaginal procedure.
Measured: 1 year
Secondary outcomes (3)
Safety and tolerability measured by individual and overall Adverse Events
- Procedural complications recorded during transvaginal cholecystectomy.
- Complications resulting from endoscopic transvaginal cholecystectomy recorded at the time of surgery.
- Patients' post-operative clinical course for duration of three months, including routine follow up at about one week after the operation, vaginal exam after six weeks and follow-up with quality of life questionnaire at three months.
Measured: Following each surgery but overall at 1 year
Pain Scores as measured on the Visual Analog Scale
One of the main endpoints of the study will be postoperative pain as measured by the visual analog scale. The scale will be measured in triplicate fashion. In addition to the visual analog scale, the amount and class of pain medication used will be collected.
Measured: 1 year
Quality of Life measured through validated questionnaires
Data for the SF-12 and ASIS will be scaled and evaluated for correlation at baseline and postoperative day 7 with the Pearson coefficient. Change from baseline for each instrument will be evaluated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Subjects not interested
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 Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliane Bingener-Casey, Mayo Clinic
- Investigators
- Juliane Bingener-Casey, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232959
- Sponsor's protocol ID
- 09-001167
- Acronym
- TVC
- Status last verified
- Jan 2016
- First submitted
- 28 Oct 2010
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Transvaginal Cholecystectomy
- ClinicalTrials.gov ID
- NCT01232959
- Acronym / sponsor ID
- TVC / 09-001167
- Conditions
- Gallstones
- Keywords
- Gallbladder removal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subjects not interested
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Nov 2010 (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.
Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. It is the current standard. It has replaced traditional open gallbladder surgery. Open gallbladder surgery is done with a large incision. A new way of removing the gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This study is being done to see if removing the gallbladder through the vagina will work for patients at Mayo Clinic Rochester. This is the first step of this research to test the procedure. In the future, other studies will examine the potential for less scarring and reduced pain. In this study the investigators will still make small incisions in the abdomen, they will be smaller than the standard procedure but you will still have some scars on your abdomen.
Some very early research reports say that some patients may have less pain with the transvaginal approach; however, the investigators do not know if the transvaginal route will have any effect on your overall health and quality of life.
This study will evaluate:
- Effectiveness of the surgery: ability to remove the gallbladder safely
- Effect of the operation on your body: change in pulse and blood pressure during the surgery, level of inflammation markers in your blood before and after the surgery
- Recovery from surgery in the hospital: how much pain you have, how much pain medication you need, how long you need to stay in the hospital, or nature of any surgical complications (problems)
- Overall recovery from surgery: general quality of life, abdominal symptoms
What is the new type of surgery?
The new type of surgery is called transvaginal cholecystectomy:
A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.
Detailed description
As technologic innovations in medicine continue to advance, less intrusive operative procedures are being developed. Natural Orifice Transluminal Endoscopic Surgery (NOTES) may represent a less invasive approach to the abdominal cavity. The access to the abdominal cavity through natural orifices such as the vagina has the benefit of decreased somato-sensory innervation. This venue might confer less pain and operative stress to the patient. The transvaginal approach has been suggested as a new surgical approach to gallbladder surgery (cholecystectomy). Approximately 700 transvaginal cholecystectomy procedures have been performed in medical centers around the world so far. Anecdotal data suggest that the patients experience less pain postoperatively and half of them may not require any pain medication. Currently, introduction of this new operative approach outside of a research study is not supported by national nor international societies.
We wish to demonstrate that the transvaginal approach is feasible for 10 patients with gallstone disease at Mayo Clinic Rochester (MCR).
Methods: Female patients seen by consultants from the Division of General and Gastrointestinal Surgery, who have an appropriate indication for elective cholecystectomy, will be offered a cholecystectomy via the transvaginal approach. After patient enrollment, baseline demographics, questionnaires and blood draws will be obtained. The patient will undergo a laparoscopic assisted transvaginal cholecystectomy by a dedicated surgical team, consisting of a gynecologist, a minimally invasive surgeon and a gastroenterologist. This approach will utilize a 5-mm umbilical trocar and a posterior colpotomy. Standard laparoscopic and flexible endoscopic instrumentation will be utilized along with recently introduced long flexible-tip laparoscopic instrumentation to remove the gallbladder. Intraoperative parameters will be recorded. Postoperatively blood draws and questionnaires will be repeated at specific intervals.
Data analysis will be mainly descriptive for this feasibility study. The collected material will serve as pilot data for a future comparative study of transvaginal cholecystectomy with standard laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Surgery | Experimental | Device: Transvaginal CholecystectomyGallbladder will be removed through the vagina |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients undergoing elective cholecystectomy for cholelithiasis.
Key exclusion criteria (18 listed)
- Male patients, patients <18 years or >65 years of age
- Pregnant patients
- Patients with prior pelvic surgery
- Patients with prior hepatobiliary surgery or other major abdominal surgery
- Patients with ASA class >3
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 |
|---|---|---|
| Transvaginal CholecystectomyAlso: gallbladder removalA small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina. | Device | Transvaginal Surgery |
Primary outcome
Feasibility measured by successful transvaginal removal of gallbladder
Time frame: 1 year
The procedure will be considered technically successful if at completion the cystic duct and artery have been clipped securely and the gallbladder has been removed through the transvaginal port. At the time of surgery, the procedure will be supervised with a laparoscope at all critical points. Conversion to a laparoscopic or open procedure is considered an incomplete transvaginal procedure.
3 secondary outcomes
Safety and tolerability measured by individual and overall Adverse Events
Time frame: Following each surgery but overall at 1 year
Pain Scores as measured on the Visual Analog Scale
Time frame: 1 year
Quality of Life measured through validated questionnaires
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
Related trials for Gallstones
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
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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
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Timing of CHolecystectomy In Severe PAncreatitis
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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.
Juliane Bingener-Casey, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal Cholecystectomy in people with Gallstones, run by Mayo Clinic.
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 1 inclusion and 18 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: withdrawn, as of the sponsor's last update on 13 Jan 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility measured by successful transvaginal removal of gallbladder (time frame: 1 year). 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 13 Jan 2016.