CholelithiasisPhase 3NCT00835250
Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery
A Phase 3 study testing Transvaginal hybrid NOTES cholecystectomy and Cholecystectomy in people with Cholelithiasis, run by Hospital Son Llatzer at 1 site in Spain.
Trial summary
The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery). 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 hybrid NOTES cholecystectomy and Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Apr 2012
- Phase
- Phase 3
- 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
- age over 18 and under 65
- symptomatic cholelithiasis with an indication for performing laparoscopic surgery
- absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
- perforated hymen
- agreement on the patient's part not to use the vagina for two weeks after the surgery
- signed specific informed consent upon providing specific information about the new surgical approach.
Who cannot join
- age under 18 or over 65
- unperforated hymen
- presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)
The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).
Read the detailed description
Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present time these procedures are hybrids. It is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity.
Methods. Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.
- Conditions
- Cholelithiasis
- Being tested
- Transvaginal hybrid NOTES cholecystectomy, Cholecystectomy
- Keywords
- Transvaginal cholecystectomy, NOTES, Minilaparoscopy, Endoscopic surgery, Cholecystectomy, Surgical translumenal endoscopic surgery, Transvaginal translumenal endoscopic surgery
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal hybrid NOTES cholecystectomyProcedure or surgery
Also called NOTES cholecystectomy, Transvaginal cholecystectomy
Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.
CholecystectomyProcedure or surgery
Extirpation of the gallbladder by a surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Active comparator | Laparoscopic cholecystectomy Receives: Procedure: Cholecystectomy |
| Transumbilical | Experimental | Transumbilical endoscopic cholecystectomy Receives: Procedure: Cholecystectomy |
| Transvaginal | Experimental | Transvaginal endoscopic cholecystectomy Receives: Procedure: Transvaginal hybrid NOTES cholecystectomy; Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parietal complications after surgery (infection and hernia)
Measured: One year
Secondary outcomes (1)
Surgical pain. General complications. Patient's preferences.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose F. Noguera, Hospital Son Llatzer
- Investigators
- Angel Cuadrado, MD PhD, Study chair, Hospital Son Llàtzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835250
- Sponsor's protocol ID
- LLATZERNOTES-2
- Status last verified
- Mar 2013
- First submitted
- 2 Feb 2009
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dolz C, Noguera JF, Martin A, Vilella A, Cuadrado A. [Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy]. Rev Esp Enferm Dig. 2007 Dec;99(12):698-702. doi: 10.4321/s1130-01082007001200004. Spanish.
PubMed 18290693Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012 Dec;26(12):3435-41. doi: 10.1007/s00464-012-2359-4. Epub 2012 May 31.
PubMed 22648123
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing Laparoscopic Cholecystectomy and Hybrid Natural Orifice Translumenal Endoscopic Surgery (NOTES)
- ClinicalTrials.gov ID
- NCT00835250
- Acronym / sponsor ID
- LLATZERNOTES-2
- Conditions
- Cholelithiasis
- Keywords
- Transvaginal cholecystectomy, NOTES, Minilaparoscopy, Endoscopic surgery, Cholecystectomy, Surgical translumenal endoscopic surgery, Transvaginal translumenal endoscopic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Feb 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 purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).
Detailed description
Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present time these procedures are hybrids. It is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity.
Methods. Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | Active comparator | Procedure: CholecystectomyLaparoscopic cholecystectomy |
| Transumbilical | Experimental | Procedure: CholecystectomyTransumbilical endoscopic cholecystectomy |
| Transvaginal | Experimental | Procedure: Transvaginal hybrid NOTES cholecystectomy, Procedure: CholecystectomyTransvaginal endoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age over 18 and under 65
- symptomatic cholelithiasis with an indication for performing laparoscopic surgery
- absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
- perforated hymen
- agreement on the patient's part not to use the vagina for two weeks after the surgery
Key exclusion criteria (3 listed)
- age under 18 or over 65
- unperforated hymen
- presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.
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 hybrid NOTES cholecystectomyAlso: NOTES cholecystectomy, Transvaginal cholecystectomyCholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope. | Procedure or surgery | Transvaginal |
| CholecystectomyExtirpation of the gallbladder by a surgical procedure | Procedure or surgery | Laparoscopy, Transumbilical, Transvaginal |
Primary outcome
Parietal complications after surgery (infection and hernia)
Time frame: One year
1 secondary outcome
Surgical pain. General complications. Patient's preferences.
Time frame: One year
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 12 Mar 2013.
- Results publication: PubMed 18290693Dolz C, Noguera JF, Martin A, Vilella A, Cuadrado A. [Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy]. Rev Esp Enferm Dig. 2007 Dec;99(12):698-702. doi: 10.4321/s1130-01082007001200004. Spanish.
- Derived from this study: PubMed 22648123Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012 Dec;26(12):3435-41. doi: 10.1007/s00464-012-2359-4. Epub 2012 May 31.
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.
Angel Cuadrado, MD PhD study chair
Hospital Son Llàtzer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transvaginal hybrid NOTES cholecystectomy and Cholecystectomy in people with Cholelithiasis, run by Hospital Son Llatzer at 1 site in Spain.
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 3 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 12 Mar 2013. 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 Spain. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Parietal complications after surgery (infection and hernia) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00835250, which also lists 2 linked publications.
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 12 Mar 2013.