Gall Bladder DiseasesNCT01171027
Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy
A study testing NOTES Cholecystectomy and Laparoscopic Cholecystectomy in people with Gall Bladder Diseases, run by Natural Orifice Surgery Consortium for Assessment and Research at 6 sites in United States.
Trial summary
This study is designed to be a United States multicenter prospective randomized controlled non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in elective surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gall Bladder Diseases
- What is being tested?
- NOTES Cholecystectomy and Laparoscopic Cholecystectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2010to Sep 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Competent male or female subjects, between the ages of 18-75 and who present for elective cholecystectomy will be offered participation in this study.
- Male subjects must be willing to have the cholecystectomy by either the laparoscopic or transgastric NOTES approach.
- Female subjects must be willing to have the cholecystectomy by either the laparoscopic or either the NOTES approaches (transgastric and/or transvaginal) being performed at the site.
- Patients offered participation in this study must provide written, informed consent and meet the following criteria prior to randomization.
- Diagnosis of benign gallstone disease which requires cholecystectomy.
- ASA Class 1 or 2.
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- Willingness to have laparoscopic cholecystectomy performed and have research data collected for control group.
- Willingness to have abdomen photographed (for cosmesis assessment).
- For sites performing transgastric NOTES approach
- Willingness to have cholecystectomy performed via NOTES transgastric approach.
- Willingness to have NOTES procedure videotaped.
- For sites performing transvaginal NOTES approach - Female subjects only
- Willingness to have cholecystectomy performed via NOTES transvaginal approach.
- Willingness to have intra-abdominal procedure digitally recorded.
- Pelvic examination in the past 12 months without significant pathology.
Who cannot join
- Pregnant women.
- Obese patients (BMI > 35).
- Patients with severe medical comorbidities (ie, NOT ASA Class 1 or 2) will be excluded such as:
- Chronic renal failure
- Chronic liver disease
- Congestive heart failure
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- Patients with a presumed gallbladder malignancy.
- Patients with a history of prior open abdominal or laparoscopic or transvaginal surgery. However patients with prior appendectomy, tubal ligation or Cesarean section will be included.
- Patients who are taking immunosuppressive medications and/or immunocompromised.
- Patients with a prior history of perineal trauma leading to significant alteration of vaginal anatomy.
- Patients with a history of ectopic pregnancy, pelvic inflammatory disease, large fibroids or severe endometriosis.
- Patients with known common bile duct stones. (ie, not cleared prior to surgery). Patients with common bile duct stones discovered intra-operatively will remain in the study.
- Patients on anticoagulation drugs other than once daily aspirin. Abnormal blood coagulation tests. Minimal abnormalities may be allowed at the discretion of site principal investigator.
- Gallstones> 2.5cm in diameter.
- Presence of untreated esophageal stricture.
- Surgically altered gastric anatomy or severe uncorrected paraesophageal types 2, 3 or 4.
- Unwillingness to consent to NOTES procedure(s).
- Acute cholecystitis or cholangitis
- For sites performing transgastric NOTES approach
- Contraindicated for esophagogastroduodenoscopy (EGD).
- Patients with hypersecretory states.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Eric Hungness, MD
Eric Hungness, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43212
Jeffrey Hazey, MD
- Recruiting
Yale University
New Haven, Connecticut, 06520
Kurt Roberts, MD
Kurt Roberts, MD
- Recruiting
Oregon Clinic
Portland, Oregon, 97213
Lee Swanstrom, MD, lswanstrom@aol.com
Lee Swanstrom, MD
- Recruiting
University of California at San Diego
San Diego, California, 92103-8400
Santiago Horgan, MD, 619-543-2379, shorgan@ucsd.edu
Mark Talamini, MD, (619) 543-2379, talamini@ucsd.edu
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
John Romanelli, MD, 413-794-5164, john.romanelli@baystatehealth.org
David Earle, MD, 413-794-5164, david.earle@baystatehealth.org
About this study
This study is designed to be a United States multicenter prospective randomized controlled non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative outcomes will be measured.
Read the detailed description
Primary To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
Secondary To assess cosmesis associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To assess objective operative cost and logistical comparisons between transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To identify unforeseen barriers to transgastric or transvaginal surgery adoption.
- Conditions
- Gall Bladder Diseases
- Being tested
- NOTES Cholecystectomy, Laparoscopic Cholecystectomy
- Keywords
- Cholecystectomy, NOTES, Transvaginal, Transgastric, Natural orifice, Gallbladder removal
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTES CholecystectomyProcedure or surgery
The transvaginal NOTES approach is accomplished by performing a posterior colpotomy. Instead of a conventional laparoscope, a flexible endoscope is used in order to provide working channels and visualization. The gallbladder is removed through the vaginal incision. The transgastric cholecystectomy requires the flexible endoscope to be placed orally. A gastrotomy is made through the stomach wall allowing the flexible endoscope to pass into the abdominal cavity. The gallbladder is removed from the abdominal cavity into the stomach and ultimately out the mouth. The goal of NOTES is to develop further so either of these approaches will not require any incisions in the abdominal wall.
Laparoscopic CholecystectomyProcedure or surgery
This technique utilizes the introduction of a laparoscope through a 1 cm incision in the fascia in or around umbilicus. Usually three additional 0.5- 1.0 cm incisions are employed for surgical instrumentation. Once separated from its attachments, the gallbladder is usually removed through the umbilical port. Sutures are used to close the larger port sites. The most devastating complication is injury to the major bile ducts which is avoided to the extent possible (incidence .2 to less than .01%)5 by careful visualization of the ductal structures.
| Study group | Role | What they receive |
|---|---|---|
| NOTES(R) Cholecystectomy | Experimental | Natural Orifice Translumenal Endoscopic Surgery techniques Receives: Procedure: NOTES Cholecystectomy |
| Laparoscopic Cholecystectomy | Active comparator | Laparoscopic Cholecystectomy Receives: Procedure: NOTES Cholecystectomy; Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
Measured: 4 weeks post surgery
Secondary outcomes (1)
To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
Measured: 4 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall Bladder DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Orifice Surgery Consortium for Assessment and Research
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Sponsor
- Investigators
- Steven Schwaitzberg, MD, Principal investigator, Cambridge Health AllianceMichael L. Kochman, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171027
- Sponsor's protocol ID
- NOTES® Trial
- Status last verified
- Nov 2011
- First submitted
- 26 Jul 2010
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy
- ClinicalTrials.gov ID
- NCT01171027
- Acronym / sponsor ID
- NOTES® Trial
- Conditions
- Gall Bladder Diseases
- Keywords
- Cholecystectomy, NOTES, Transvaginal, Transgastric, Natural orifice, Gallbladder removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Natural Orifice Surgery Consortium for Assessment and ResearchUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 28 Jul 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.
This study is designed to be a United States multicenter prospective randomized controlled non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative outcomes will be measured.
Detailed description
Primary To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
Secondary To assess cosmesis associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To assess objective operative cost and logistical comparisons between transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
To identify unforeseen barriers to transgastric or transvaginal surgery adoption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOTES(R) Cholecystectomy | Experimental | Procedure: NOTES CholecystectomyNatural Orifice Translumenal Endoscopic Surgery techniques |
| Laparoscopic Cholecystectomy | Active comparator | Procedure: NOTES Cholecystectomy, Procedure: Laparoscopic CholecystectomyLaparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Competent male or female subjects, between the ages of 18-75 and who present for elective cholecystectomy will be offered participation in this study.
- Male subjects must be willing to have the cholecystectomy by either the laparoscopic or transgastric NOTES approach.
- Female subjects must be willing to have the cholecystectomy by either the laparoscopic or either the NOTES approaches (transgastric and/or transvaginal) being performed at the site.
- Patients offered participation in this study must provide written, informed consent and meet the following criteria prior to randomization.
- Diagnosis of benign gallstone disease which requires cholecystectomy.
Key exclusion criteria (21 listed)
- Pregnant women.
- Obese patients (BMI > 35).
- Patients with severe medical comorbidities (ie, NOT ASA Class 1 or 2) will be excluded such as:
- Chronic renal failure
- Chronic liver disease
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 |
|---|---|---|
| NOTES CholecystectomyThe transvaginal NOTES approach is accomplished by performing a posterior colpotomy. Instead of a conventional laparoscope, a flexible endoscope is used in order to provide working channels and visualization. The gallbladder is removed through the vaginal incision. The transgastric cholecystectomy requires the flexible endoscope to be placed orally. A gastrotomy is made through the stomach wall allowing the flexible endoscope to pass into the abdominal cavity. The gallbladder is removed from the abdominal cavity into the stomach and ultimately out the mouth. The goal of NOTES is to develop further so either of these approaches will not require any incisions in the abdominal wall. | Procedure or surgery | Laparoscopic Cholecystectomy, NOTES(R) Cholecystectomy |
| Laparoscopic CholecystectomyThis technique utilizes the introduction of a laparoscope through a 1 cm incision in the fascia in or around umbilicus. Usually three additional 0.5- 1.0 cm incisions are employed for surgical instrumentation. Once separated from its attachments, the gallbladder is usually removed through the umbilical port. Sutures are used to close the larger port sites. The most devastating complication is injury to the major bile ducts which is avoided to the extent possible (incidence .2 to less than .01%)5 by careful visualization of the ductal structures. | Procedure or surgery | Laparoscopic Cholecystectomy |
Primary outcome
To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
Time frame: 4 weeks post surgery
1 secondary outcome
To assess pain associated with transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy.
Time frame: 4 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- NOSCAR web siteLink provided by the sponsor.
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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.
Steven Schwaitzberg, MD principal investigator
Cambridge Health Alliance
Michael L. Kochman, MD principal investigator
University of Pennsylvania
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOTES Cholecystectomy and Laparoscopic Cholecystectomy in people with Gall Bladder Diseases, run by Natural Orifice Surgery Consortium for Assessment and Research at 6 sites in United States.
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 15 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Kochman, MD (215 662 4279, michael.kochman@uphs.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and efficacy of transgastric and transvaginal cholecystectomy compared to conventional laparoscopic cholecystectomy. (time frame: 4 weeks post surgery). 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 2 Dec 2011.