CholelithiasisPhase 3NCT01558414
Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy
A Phase 3 study testing SILS Cholecystectomy, FSIS cholecystectomy and Conventional laparoscopy in people with Cholelithiasis and Surgery, run by Jose F. Noguera at 1 site in Spain.
Trial summary
Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a transumbilical single site incision will be performed with two different manners: single-port device SILS TM (Single Incision Laparoscopic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholelithiasis, Surgery, Laparoscopy
- What is being tested?
- SILS Cholecystectomy, FSIS cholecystectomy and Conventional laparoscopy
- 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
- Apr 2011to Nov 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 and under 65
- symptomatic cholelithiasis with an indication for laparoscopic surgery
- signed specific informed consent including specific information of the new surgical approach
- ASA 1 and 2.
Who cannot join
- current or previous cholecystitis
- current or previous suspected bile duct's problems
- previous abdominal surgery
- umbilical and other abdominal hernias
- some other condition with increased risk to infection or abdominal wall problems.
- ASA 3 and more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy
Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a transumbilical single site incision will be performed with two different manners: single-port device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the control one, a conventional laparoscopic approach.
The trial is designed as a pilot study to assess, as main objective, if these two endoscopic approaches have the same security and effectiveness in cholecystectomy.
Read more
Hypothesis:
Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy.
Objectives:
Main objective:
Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy.
Secondary objectives:
Investigate the differences in the rate of conversion to open surgery between different surgical approaches.
Investigate the differences in the rate of wound infection between the different surgical approaches.
Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches.
Investigate whether there are differences in the rate of overall complications, all-cause mortality and the cost between different surgical approaches.
Read the detailed description
Inclusion criteria:
- Patients affected with symptomatic cholelithiasis with elective surgical indication, not urgent, aged between 18 and 65.
- Signing of informed consent for cholecystectomy and specific consent for the trial.
- Anesthetic risk ASA I-II.
Exclusion criteria:
- Presence of acute cholecystitis and / or suspicion of occupation of the main bile duct.
- ASA III and higher.
- Conditions
- Cholelithiasis, Surgery, Laparoscopy
- Being tested
- SILS Cholecystectomy, FSIS cholecystectomy, Conventional laparoscopy
- Keywords
- Cholecystectomy, Minimally invasive surgery, Laparoscopic surgery, Single incision surgery
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILS CholecystectomyProcedure or surgery
Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
FSIS cholecystectomyProcedure or surgery
Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
Conventional laparoscopyProcedure or surgery
Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).
| Study group | Role | What they receive |
|---|---|---|
| SILS | Experimental | Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device Receives: Procedure: SILS Cholecystectomy |
| FSIS | Experimental | Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus Receives: Procedure: FSIS cholecystectomy |
| Conventional laparoscopy | Active comparator | Cholecystectomy performed by a conventional laparoscopic approach Receives: Procedure: Conventional laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical safety
Number of patients without clinical problems in the surgery
Measured: During surgical intervention
Secondary outcomes (1)
Conversion to other surgical approach
Rate of conversion to conventional laparoscopic surgery and open surgery.
Measured: During the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Jose F. Noguera
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mateo Orfila
- Responsible party
- Sponsor-investigator, Jose F. Noguera, Hospital Son Llatzer
- Investigators
- José F Noguera, MD, PhD, Study director, Hospital Son LlàtzerJuan C García, MD, Study chair, Hospital Son Llàtzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558414
- Sponsor's protocol ID
- Llatzer-FSIS
- Status last verified
- Mar 2013
- First submitted
- 17 Mar 2012
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanchez-Margallo FM, Perez FJ, Sanchez MA, Asencio JM, del Carmen Tejonero M, Moreno C, Noguera J. Hybrid notes cholecystectomy in an experimental model of laparoscopic acute cholecystitis. Surg Laparosc Endosc Percutan Tech. 2011 Apr;21(2):e65-9. doi: 10.1097/SLE.0b013e31820a2079.
PubMed 21471782Noguera JF, Cuadrado A, Sanchez-Margallo FM, Dolz C, Asencio JM, Olea JM, Morales R, Lozano L, Vicens JC. Emergency transvaginal hybrid natural orifice transluminal endoscopic surgery. Endoscopy. 2011 May;43(5):442-4. doi: 10.1055/s-0030-1256042. Epub 2010 Dec 16.
PubMed 21165824Noguera J, Dolz C, Cuadrado A, Olea J, Vilella A, Morales R. Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series. Surg Endosc. 2009 Apr;23(4):876-81. doi: 10.1007/s00464-008-0288-z. Epub 2009 Jan 1.
PubMed 19118420Noguera J, Tejada S, Tortajada C, Sanchez A, Munoz J. Prospective, randomized clinical trial comparing the use of a single-port device with that of a flexible endoscope with no other device for transumbilical cholecystectomy: LLATZER-FSIS pilot study. Surg Endosc. 2013 Nov;27(11):4284-90. doi: 10.1007/s00464-013-3044-y. Epub 2013 Jun 29.
PubMed 23812286
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 Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy
- ClinicalTrials.gov ID
- NCT01558414
- Acronym / sponsor ID
- Llatzer-FSIS
- Conditions
- Cholelithiasis, Surgery, Laparoscopy
- Keywords
- Cholecystectomy, Minimally invasive surgery, Laparoscopic surgery, Single incision surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jose F. NogueraUniversity, hospital or other
- Collaborators
- Hospital Mateo Orfila
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Mar 2012 (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.
Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a transumbilical single site incision will be performed with two different manners: single-port device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the control one, a conventional laparoscopic approach.
The trial is designed as a pilot study to assess, as main objective, if these two endoscopic approaches have the same security and effectiveness in cholecystectomy.
Hypothesis:
Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy.
Objectives:
Main objective:
Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy.
Secondary objectives:
Investigate the differences in the rate of conversion to open surgery between different surgical approaches.
Investigate the differences in the rate of wound infection between the different surgical approaches.
Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches.
Investigate whether there are differences in the rate of overall complications, all-cause mortality and the cost between different surgical approaches.
Detailed description
Inclusion criteria:
- Patients affected with symptomatic cholelithiasis with elective surgical indication, not urgent, aged between 18 and 65.
- Signing of informed consent for cholecystectomy and specific consent for the trial.
- Anesthetic risk ASA I-II.
Exclusion criteria:
- Presence of acute cholecystitis and / or suspicion of occupation of the main bile duct.
- ASA III and higher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SILS | Experimental | Procedure: SILS CholecystectomyCholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device |
| FSIS | Experimental | Procedure: FSIS cholecystectomyCholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus |
| Conventional laparoscopy | Active comparator | Procedure: Conventional laparoscopyCholecystectomy performed by a conventional laparoscopic approach |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18 and under 65
- symptomatic cholelithiasis with an indication for laparoscopic surgery
- signed specific informed consent including specific information of the new surgical approach
- ASA 1 and 2.
Key exclusion criteria (6 listed)
- current or previous cholecystitis
- current or previous suspected bile duct's problems
- previous abdominal surgery
- umbilical and other abdominal hernias
- some other condition with increased risk to infection or abdominal wall problems.
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 |
|---|---|---|
| SILS CholecystectomyCholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device | Procedure or surgery | SILS |
| FSIS cholecystectomyCholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus | Procedure or surgery | FSIS |
| Conventional laparoscopyMinimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports). | Procedure or surgery | Conventional laparoscopy |
Primary outcome
Surgical safety
Time frame: During surgical intervention
Number of patients without clinical problems in the surgery
1 secondary outcome
Conversion to other surgical approach
Time frame: During the surgical intervention
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.
- Background: PubMed 21471782Sanchez-Margallo FM, Perez FJ, Sanchez MA, Asencio JM, del Carmen Tejonero M, Moreno C, Noguera J. Hybrid notes cholecystectomy in an experimental model of laparoscopic acute cholecystitis. Surg Laparosc Endosc Percutan Tech. 2011 Apr;21(2):e65-9. doi: 10.1097/SLE.0b013e31820a2079.
- Background: PubMed 21165824Noguera JF, Cuadrado A, Sanchez-Margallo FM, Dolz C, Asencio JM, Olea JM, Morales R, Lozano L, Vicens JC. Emergency transvaginal hybrid natural orifice transluminal endoscopic surgery. Endoscopy. 2011 May;43(5):442-4. doi: 10.1055/s-0030-1256042. Epub 2010 Dec 16.
- Background: PubMed 19118420Noguera J, Dolz C, Cuadrado A, Olea J, Vilella A, Morales R. Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series. Surg Endosc. 2009 Apr;23(4):876-81. doi: 10.1007/s00464-008-0288-z. Epub 2009 Jan 1.
- Derived from this study: PubMed 23812286Noguera J, Tejada S, Tortajada C, Sanchez A, Munoz J. Prospective, randomized clinical trial comparing the use of a single-port device with that of a flexible endoscope with no other device for transumbilical cholecystectomy: LLATZER-FSIS pilot study. Surg Endosc. 2013 Nov;27(11):4284-90. doi: 10.1007/s00464-013-3044-y. Epub 2013 Jun 29.
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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.
José F Noguera, MD, PhD study director
Hospital Son Llàtzer
Juan C García, MD 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 SILS Cholecystectomy, FSIS cholecystectomy and Conventional laparoscopy in people with Cholelithiasis and Surgery, run by Jose F. Noguera 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 4 inclusion and 6 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?
Surgical safety (time frame: During surgical intervention). 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 NCT01558414, which also lists 4 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.