CholecystitisNOTEScholeNCT01174069
Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder
A study testing NOTES assisted laparoscopic cholecystectomy in people with Cholecystitis, run by The Oregon Clinic at 1 site in United States.
Trial summary
Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. Patient benefits will include less pain and scaring. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- NOTES assisted laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Oct 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to undergo general anesthesia
- Age > 18 years of age and < 80 years of age
- Ability to give informed consent
Who cannot join
- Acute cholecystitis
- Body Mass Index (BMI) > 40
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Gallstones > 2.5cm in diameter
- Gall bladder more than 15cm in length on U/S
- Presence of common duct stones
- Presence of esophageal stricture
- Altered gastric anatomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy
Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. Patient benefits will include less pain and scaring.
Read the detailed description
In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5 cm umbilical incision. A flexible endoscope will be inserted through the mouth and into the stomach. Using commercially available endoscopes, endoscopic instruments and accessories, a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. Two to three small laparoscopic trocars will be placed for laparoscopic instrument insertion to manipulate, retract and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. Once dissected free, the gall bladder will be removed through the stomach and out of the mouth. Commercially available endoscopic clips, sutures and/or tissue anchors will be used to close the gastrotomy; additionally, the gastrotomy will be tested for leaks and laparoscopically oversewn with suture as needed.
Patients will be discharged per the standard of practice for a laparoscopic cholecystectomy. During the hospital stay severity of pain and use of pain medications will be recorded. Length of time spent in the recovery room and in the hospital will also be collected. Patients will return and be evaluated by their surgeon two weeks following their procedure. At this visit, any complications will be noted in the patient's medical record. Additionally at this visit and at the preoperative visit, patients will complete a standardized Quality of Life (QOL) assessment (i.e., SF-36) and perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
- Conditions
- Cholecystitis
- Being tested
- NOTES assisted laparoscopic cholecystectomy
- Keywords
- NOTES, cholecystectomy, endoscopic
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTES assisted laparoscopic cholecystectomyProcedure or surgery
Also called NOTES Cholecystectomy
Surgical removal of the gallbladder using endoscopic instruments.
| Study group | Role | What they receive |
|---|---|---|
| NOTES cholecystectomy | Experimental | Not described Receives: Procedure: NOTES assisted laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
Measured: 30 days
Secondary outcomes (1)
Perception of surgical outcome
standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.
Measured: 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startMay 2007
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Oregon Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Lee Swanstrom, The Oregon Clinic
- Investigators
- Christy M Dunst, MD, Principal investigator, The Oregon ClinicAngi B Gill, RN, Study director, The Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174069
- Sponsor's protocol ID
- LHS0701
- Acronym
- NOTESchole
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2010
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01174069
- Acronym / sponsor ID
- NOTESchole / LHS0701
- Conditions
- Cholecystitis
- Keywords
- NOTES, cholecystectomy, endoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Oregon ClinicUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- May 2007 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Aug 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.
Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. Patient benefits will include less pain and scaring.
Detailed description
In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5 cm umbilical incision. A flexible endoscope will be inserted through the mouth and into the stomach. Using commercially available endoscopes, endoscopic instruments and accessories, a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. Two to three small laparoscopic trocars will be placed for laparoscopic instrument insertion to manipulate, retract and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. Once dissected free, the gall bladder will be removed through the stomach and out of the mouth. Commercially available endoscopic clips, sutures and/or tissue anchors will be used to close the gastrotomy; additionally, the gastrotomy will be tested for leaks and laparoscopically oversewn with suture as needed.
Patients will be discharged per the standard of practice for a laparoscopic cholecystectomy. During the hospital stay severity of pain and use of pain medications will be recorded. Length of time spent in the recovery room and in the hospital will also be collected. Patients will return and be evaluated by their surgeon two weeks following their procedure. At this visit, any complications will be noted in the patient's medical record. Additionally at this visit and at the preoperative visit, patients will complete a standardized Quality of Life (QOL) assessment (i.e., SF-36) and perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOTES cholecystectomy | Experimental | Procedure: NOTES assisted laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to undergo general anesthesia
- Age > 18 years of age and < 80 years of age
- Ability to give informed consent
Key exclusion criteria (8 listed)
- Acute cholecystitis
- Body Mass Index (BMI) > 40
- Contraindicated for esophagogastroduodenoscopy (EGD)
- Gallstones > 2.5cm in diameter
- Gall bladder more than 15cm in length on U/S
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 assisted laparoscopic cholecystectomyAlso: NOTES CholecystectomySurgical removal of the gallbladder using endoscopic instruments. | Procedure or surgery | NOTES cholecystectomy |
Primary outcome
Postoperative pain
Time frame: 30 days
perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.
1 secondary outcome
Perception of surgical outcome
Time frame: 30 days post operatively
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 3 Sep 2019.
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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.
Christy M Dunst, MD principal investigator
The Oregon Clinic
Angi B Gill, RN study director
The Oregon Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOTES assisted laparoscopic cholecystectomy in people with Cholecystitis, run by The Oregon Clinic 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 3 inclusion and 8 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 3 Sep 2019. 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 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?
Postoperative pain (time frame: 30 days). 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 3 Sep 2019.