CholelithiasisPhase 1/2NCT00710502
Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial
A Phase 1/2 study testing Transvaginal NOTES cholecystectomy and Laparoscopic cholecystectomy in people with Cholelithiasis, run by Universidad Juarez del Estado de Durango at 1 site in Mexico.
Trial summary
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been estimated to cost U.S. healthcare $5 billion/year. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Transvaginal NOTES cholecystectomy and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 1/2
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 years old) female patients residents of Durango Mexico.
- Patients who undergo elective surgery.
- Patients with ultrasound documented symptomatic cholelithiasis, gallbladder polyps of biliary dyskinesia.
- Patients capable of giving written informed consent for the study.
Who cannot join
- Patients who have contraindications prohibiting general anesthesia.
- Pregnancy.
- Previous abdominal or gynecological procedures.
- Uncontrollable medical or psychiatric conditions
- Elderly > 65 y/o.
- Body Mass Index > 35 mg/kg2.
Show all 12Show fewer
- Complicated or acute cholecystitis.
- Elevation of liver function tests.
- Acute abdomen.
- Intra-abdominal abscess.
- Coagulopathy.
- Imperforated hymen.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Juarez del Estado de Durango, Mexico
Durango, Durango, 34000
About this study
Official title: Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic cholecystectomy was introduced in the early 1990s and has become the standard surgical approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed as an outpatient basis and is related to a very low complication rate. Laparoscopic cholecystectomy requires the use of multiple trocar incisions.
Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure currently being studied around the world. The idea of NOTES was developed several years ago in response to the concepts that patients would
Read more
- realize the benefits of less invasive surgery by reducing the recovery time,
- experience less physical discomfort associated with traditional procedures
- have virtually no visible scarring following this type of surgery.
All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold tremendous potential, there are many issues that need to be addressed before this technique is introduced into clinical care.
The purpose of this study is to determine the safety, feasibility and short-term clinical outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).
Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with symptomatic cholelithiasis.
Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.
Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal NOTES cholecystectomy to Laparoscopic cholecystectomy.
Read the detailed description
Most recently, surgeons and endoscopists have focused on NOTES cholecystectomy. Access to the abdominal cavity to perform NOTES procedures has been obtained by transgastric, transvaginal, transvesical and transrectal approaches. The first successful NOTES procedure in humans was an appendectomy in India. Transvaginal NOTES cholecystectomy has been successfully performed and reported in a handful of cases in the US, Europe and South America. However, to date, there is lack of clinical trials that demonstrate the safety and feasibility of Transvaginal NOTES cholecystectomy in a larger group of patients.
- Conditions
- Cholelithiasis
- Being tested
- Transvaginal NOTES cholecystectomy, Laparoscopic cholecystectomy
- Keywords
- Transvaginal, NOTES, Cholecystectomy, Laparoscopic
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal NOTES cholecystectomyProcedure or surgery
Also called NOTES gallbladder removal, NOTES gallbladder surgery
Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
Laparoscopic cholecystectomyProcedure or surgery
Also called Small incision gallbladder surgery
Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Transvaginal NOTES Cholecystectomy (Phase 1) Receives: Procedure: Transvaginal NOTES cholecystectomy |
| 2 | Active comparator | Laparoscopic Cholecystectomy (Phase 2) Receives: Procedure: Laparoscopic cholecystectomy |
| 3 | Experimental | Transvaginal NOTES cholecystectomy (Phase 2) Receives: Procedure: Transvaginal NOTES cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy
Measured: 12 months
Secondary outcomes (1)
Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Juarez del Estado de Durango
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Investigators
- Homero Rivas, MD, Principal investigator, Hospital de la Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710502
- Sponsor's protocol ID
- 05626
- Status last verified
- Dec 2009
- First submitted
- 2 Jul 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial
- ClinicalTrials.gov ID
- NCT00710502
- Acronym / sponsor ID
- 05626
- Conditions
- Cholelithiasis
- Keywords
- Transvaginal, NOTES, Cholecystectomy, Laparoscopic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Juarez del Estado de DurangoUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jul 2008 (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.
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic cholecystectomy was introduced in the early 1990s and has become the standard surgical approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed as an outpatient basis and is related to a very low complication rate. Laparoscopic cholecystectomy requires the use of multiple trocar incisions.
Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure currently being studied around the world. The idea of NOTES was developed several years ago in response to the concepts that patients would
- realize the benefits of less invasive surgery by reducing the recovery time,
- experience less physical discomfort associated with traditional procedures
- have virtually no visible scarring following this type of surgery.
All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold tremendous potential, there are many issues that need to be addressed before this technique is introduced into clinical care.
The purpose of this study is to determine the safety, feasibility and short-term clinical outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).
Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with symptomatic cholelithiasis.
Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.
Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal NOTES cholecystectomy to Laparoscopic cholecystectomy.
Detailed description
Most recently, surgeons and endoscopists have focused on NOTES cholecystectomy. Access to the abdominal cavity to perform NOTES procedures has been obtained by transgastric, transvaginal, transvesical and transrectal approaches. The first successful NOTES procedure in humans was an appendectomy in India. Transvaginal NOTES cholecystectomy has been successfully performed and reported in a handful of cases in the US, Europe and South America. However, to date, there is lack of clinical trials that demonstrate the safety and feasibility of Transvaginal NOTES cholecystectomy in a larger group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Transvaginal NOTES cholecystectomyTransvaginal NOTES Cholecystectomy (Phase 1) |
| 2 | Active comparator | Procedure: Laparoscopic cholecystectomyLaparoscopic Cholecystectomy (Phase 2) |
| 3 | Experimental | Procedure: Transvaginal NOTES cholecystectomyTransvaginal NOTES cholecystectomy (Phase 2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (> 18 years old) female patients residents of Durango Mexico.
- Patients who undergo elective surgery.
- Patients with ultrasound documented symptomatic cholelithiasis, gallbladder polyps of biliary dyskinesia.
- Patients capable of giving written informed consent for the study.
Key exclusion criteria (12 listed)
- Patients who have contraindications prohibiting general anesthesia.
- Pregnancy.
- Previous abdominal or gynecological procedures.
- Uncontrollable medical or psychiatric conditions
- Elderly > 65 y/o.
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 NOTES cholecystectomyAlso: NOTES gallbladder removal, NOTES gallbladder surgeryUnder general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy | Procedure or surgery | 1, 3 |
| Laparoscopic cholecystectomyAlso: Small incision gallbladder surgeryUnder general anesthesia, patients will undergo standard Laparoscopic cholecystectomy | Procedure or surgery | 2 |
Primary outcome
Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy
Time frame: 12 months
1 secondary outcome
Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy
Time frame: 12 months
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 15 Dec 2009.
Related trials for Cholelithiasis
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.
Homero Rivas, MD principal investigator
Hospital de la Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transvaginal NOTES cholecystectomy and Laparoscopic cholecystectomy in people with Cholelithiasis, run by Universidad Juarez del Estado de Durango at 1 site in Mexico.
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 4 inclusion and 12 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 15 Dec 2009. 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 Mexico. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy (time frame: 12 months). 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 15 Dec 2009.