GallstonesNCT01039129
Hybrid Transvaginal-Transabdominal Endoscopic Surgery
A study testing Endoscopic Cholecystectomy, Endoscopic Appendectomy and Endoscopic Peritoneoscopy in people with Gallstones and Appendicitis, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Gallstones, Appendicitis, Pelvic Pain
- What is being tested?
- Endoscopic Cholecystectomy, Endoscopic Appendectomy and Endoscopic Peritoneoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Oct 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chronic or early appendicitis
- Symptomatic gallstones
- Suspicious abdominal mass/nodule
- Female
- Age 18-60 years
- ASA Class I or II
Who cannot join
- Pregnant women
- History of previous abdominal, pelvic, or vaginal surgery
- History of previous abdominal or pelvic radiation therapy
- History of fibroid uterus
- History of endometriosis
- History of large ovarian cyst
- History of unexplained vaginal bleeding or dyspareunia
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.
- Conditions
- Gallstones, Appendicitis, Pelvic Pain
- Being tested
- Endoscopic Cholecystectomy, Endoscopic Appendectomy, Endoscopic Peritoneoscopy
- Keywords
- Gallstones, Appendicitis, Pelvic pain, Peritoneal mass
- Medical subject headings
- Gallstones, Appendicitis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic CholecystectomyProcedure or surgery
An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus.
Endoscopic AppendectomyProcedure or surgery
An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus
Endoscopic PeritoneoscopyProcedure or surgery
A diagnostic peritoneoscopy with or without biopsy for any indication
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Cholecystectomy | Experimental | 20 patients in this arm will undergo cholecystectomy, or removal of the gallbladder, through this experimental approach. This arm will compose of patients with symptomatic gallstones (cholelithiasis). Receives: Procedure: Endoscopic Cholecystectomy |
| Endoscopic Appendectomy | Experimental | Participants will with chronic appendicitis will undergo appendectomy through this experimental approach. Receives: Procedure: Endoscopic Appendectomy |
| Endoscopic Peritoneoscopy | Experimental | 20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication. Receives: Procedure: Endoscopic Peritoneoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Measured: intra-operative
Complication
Measured: 1 month
Secondary outcomes (2)
Operative time
Measured: intra-operative
Sexual function
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 posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: unable to recruit participants
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio Teixeira, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039129
- Sponsor's protocol ID
- SLR IRB#09-136
- Status last verified
- Aug 2015
- First submitted
- 22 Dec 2009
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Transvaginal-Transabdominal Endoscopic Surgery
- ClinicalTrials.gov ID
- NCT01039129
- Acronym / sponsor ID
- SLR IRB#09-136
- Conditions
- Gallstones, Appendicitis, Pelvic Pain
- Keywords
- Gallstones, Appendicitis, Pelvic pain, Peritoneal mass
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Dec 2009 (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.
The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Cholecystectomy | Experimental | Procedure: Endoscopic Cholecystectomy20 patients in this arm will undergo cholecystectomy, or removal of the gallbladder, through this experimental approach. This arm will compose of patients with symptomatic gallstones (cholelithiasis). |
| Endoscopic Appendectomy | Experimental | Procedure: Endoscopic AppendectomyParticipants will with chronic appendicitis will undergo appendectomy through this experimental approach. |
| Endoscopic Peritoneoscopy | Experimental | Procedure: Endoscopic Peritoneoscopy20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chronic or early appendicitis
- Symptomatic gallstones
- Suspicious abdominal mass/nodule
- Female
- Age 18-60 years
Key exclusion criteria (7 listed)
- Pregnant women
- History of previous abdominal, pelvic, or vaginal surgery
- History of previous abdominal or pelvic radiation therapy
- History of fibroid uterus
- History of endometriosis
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 |
|---|---|---|
| Endoscopic CholecystectomyAn incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus. | Procedure or surgery | Endoscopic Cholecystectomy |
| Endoscopic AppendectomyAn incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus | Procedure or surgery | Endoscopic Appendectomy |
| Endoscopic PeritoneoscopyA diagnostic peritoneoscopy with or without biopsy for any indication | Procedure or surgery | Endoscopic Peritoneoscopy |
Primary outcome
Technical success
Time frame: intra-operative
Complication
Time frame: 1 month
2 secondary outcomes
Operative time
Time frame: intra-operative
Sexual function
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 21 Aug 2015.
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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.
Julio Teixeira, MD principal investigator
St. Luke's-Roosevelt Hospital Center, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Cholecystectomy, Endoscopic Appendectomy and Endoscopic Peritoneoscopy in people with Gallstones and Appendicitis, run by St. Luke's-Roosevelt Hospital Center at 1 site 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 6 inclusion and 7 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 21 Aug 2015. 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 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?
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?
Technical success (time frame: intra-operative). The study lists 2 primary outcomes in all. 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 21 Aug 2015.