Gallbladder DiseasesNCT00552162
NOTES Transvaginal Cholecystectomy and Appendectomy
A study testing NOTES Transvaginal Cholecystectomy and NOTES Transvaginal Appendectomy in people with Gallbladder Diseases and Appendicitis, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gallbladder Diseases, Appendicitis
- What is being tested?
- NOTES Transvaginal Cholecystectomy and NOTES Transvaginal Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2008to 1 Jan 2018
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of appendicitis
- Emergency room evaluation within 36 hours of the onset of pain
- ASA Classification
Who cannot join
- pregnant women
- Morbidly obese patients (BMI >35)
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients with evidence of an abdominal abscess or mass
- Patients who present with a clinical diagnosis of sepsis or peritonitis
- Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
Show all 10Show fewer
- Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
- Patients with diffuse peritonitis on clinical exam
- Previous trauma to the perineal area
- Patients on blood thinners or aspirin or abnormal blood coagulation tests
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Center
Jerusalem, 12000
Hadassah Medical Organization
Jerusalem
About this study
Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma.
In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.
- Conditions
- Gallbladder Diseases, Appendicitis
- Being tested
- NOTES Transvaginal Cholecystectomy, NOTES Transvaginal Appendectomy
- Medical subject headings
- Gallbladder Diseases, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTES Transvaginal CholecystectomyProcedure or surgery
The gallbladder will be dissected free and will be removed through an incision in the vagina.
NOTES Transvaginal AppendectomyProcedure or surgery
The appendix will be dissected free and will be removed through an incision in the vagina.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina. Receives: Procedure: NOTES Transvaginal Cholecystectomy |
| 2 | Active comparator | NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina. Receives: Procedure: NOTES Transvaginal Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES
Measured: continuous
Secondary outcomes (1)
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH
Measured: continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startJun 2008
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoav Mintz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552162
- Sponsor's protocol ID
- NOTES HMO-CTIL
- Other IDs
- 21-2.11.07
- Status last verified
- Apr 2016
- First submitted
- 31 Oct 2007
- Last updated
- 30 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOTES Transvaginal Cholecystectomy and Appendectomy
- ClinicalTrials.gov ID
- NCT00552162
- Acronym / sponsor ID
- NOTES HMO-CTIL
- Conditions
- Gallbladder Diseases, Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 1 Nov 2007 (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.
Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma.
In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: NOTES Transvaginal CholecystectomyNOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina. |
| 2 | Active comparator | Procedure: NOTES Transvaginal AppendectomyNOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of appendicitis
- Emergency room evaluation within 36 hours of the onset of pain
- ASA Classification
Key exclusion criteria (10 listed)
- pregnant women
- Morbidly obese patients (BMI >35)
- Patients who are taking immunosuppressive medications or are immunocompromised
- Patients with evidence of an abdominal abscess or mass
- Patients who present with a clinical diagnosis of sepsis or peritonitis
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 Transvaginal CholecystectomyThe gallbladder will be dissected free and will be removed through an incision in the vagina. | Procedure or surgery | 1 |
| NOTES Transvaginal AppendectomyThe appendix will be dissected free and will be removed through an incision in the vagina. | Procedure or surgery | 2 |
Primary outcome
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES
Time frame: continuous
1 secondary outcome
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH
Time frame: continuous
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 Jul 2020.
Related trials for Gallbladder Diseases
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Incidental Gallbladder Carcinoma :Incidence and Clinical Significance in Specimens From Routine Cholecystectomies in Sohag Locality
Gall Bladder Carcinoma
Active, not recruitingPhase 2/3
Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer
Stage II Gallbladder Cancer AJCC v8, Stage IIA Gallbladder Cancer AJCC v8
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.
Yoav Mintz, MD principal investigator
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOTES Transvaginal Cholecystectomy and NOTES Transvaginal Appendectomy in people with Gallbladder Diseases and Appendicitis, run by Hadassah Medical Organization at 2 sites in Israel.
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 10 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 Jul 2020. 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 Israel. 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?
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES (time frame: continuous). 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 Jul 2020.