CholelithiasisNCT02375529
A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
A study testing Single Incision Laparoscopic Cholecystectomy (SILC) and Four Ports Laparoscopic Cholecystectomy (4PLC) in people with Cholelithiasis, run by Consorci Sanitari Integral.
Trial summary
Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Single Incision Laparoscopic Cholecystectomy (SILC) and Four Ports Laparoscopic Cholecystectomy (4PLC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jul 2014
- 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
- age higher than 18 and lower than 80
- American Society of Anesthesiologists class (ASA) I-II,
- absence of any previous anesthetic complication,
- accompaniment by a responsible adult during 24 hours,
- symptomatic gallstones candidate to cholecystectomy
- and a signed informed consent.
Who cannot join
- a Body Mass Index (BMI) higher than 35,
- any laparoscopic contraindication,
- acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
- anti-inflammatory allergy
- psychiatric history that could hinder ambulatory procedure
About this study
Official title: Estudio Prospectivo Aleatorizado de la colecistectomía laparoscópica Por Puerto único vs colecistectomía laparoscópica Por Cuatro Puertos en Pacientes Con Colelitiasis sintomática y régimen de cirugía Sin Ingreso.
Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.
Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.
- Conditions
- Cholelithiasis
- Being tested
- Single Incision Laparoscopic Cholecystectomy (SILC), Four Ports Laparoscopic Cholecystectomy (4PLC)
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision Laparoscopic Cholecystectomy (SILC)Procedure or surgery
A 2.5-cm incision is made through the everted umbilicus down to the midline fascia, and through the fascia and the peritoneum. The multichannel port (Olympus) is introduced. Carbon dioxide is insufflated (12 mmHg) and a 30 degree 10-mm laparoscope is introduced. The operating table is put in the reverse Trendelenburg position (20 degrees), left side down. A pre-curved grasper and the monopolar electrocautery are introduced through the other 2 ports of the trocar and the dissection of the gallbladder starts in a retrograde manner. The triangle of Calot is exposed, the cystic duct and artery are separately dissected and ligated with 5 mm clips. The monopolar electrocautery is used to remove the gallbladder from the liver bed. The gallbladder is removed along with the port system from the abdominal cavity. The fascia at the port site is closed and the umbilicus is inverted.
Four Ports Laparoscopic Cholecystectomy (4PLC)Procedure or surgery
An 11-mm periumbilical port, a 10-mm left upper quadrant port , 5mm subxyphoid port, and 5-mm right lower quadrant port were used in 4-port LC. We adopted the single surgeon technique in the 4-port LC using 30-degree operating telescopes that was inserted into the umbilical port. Retraction of the gallbladder was done by the long grasping forceps through the 5-mm right lower quadrant port, whereas dissection was accomplished through the 10-mm left upper quadrant port. The cystic duct and cystic artery were clipped by a 5-mm multiple clip applicator. The gallbladder was retrieved through the umbilical port after the position of the operating telescope was changed.
Nontransparent surgical adhesive tape was applied to the standard 4-port sites at the end of the operation .
| Study group | Role | What they receive |
|---|---|---|
| Single Incision Cholesystectomy (SILC) | Experimental | Single Incision Laparoscopic Cholecystectomy (SILC): The umbilicus is grasped and a 2 cm vertical skin and fascial incision is performed. A multiport (TriPort®) is inserted under direct vision. Principles of cholecystectomy are the same as traditional laparoscopic cholecystectomy. Receives: Procedure: Single Incision Laparoscopic Cholecystectomy (SILC) |
| Four Ports Cholecystectomy (4PCL) | Active comparator | Four Ports Conventional laparoscopic cholecystectomy (4PCL): A 10mm supraumbilical incision is made and the pneumoperitoneum insufflated through a Veress needle. 4 ports are introduced: 2 of 10mm in supraumbilical and left flank and 2 of 5mm in epigastric and right flank. Receives: Procedure: Four Ports Laparoscopic Cholecystectomy (4PLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of postoperative pain
Measured: 2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMay 2011
- Primary completionJul 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375529
- Sponsor's protocol ID
- 11/19
- Status last verified
- Feb 2015
- First submitted
- 12 Nov 2014
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Prospectivo Aleatorizado de la colecistectomía laparoscópica Por Puerto único vs colecistectomía laparoscópica Por Cuatro Puertos en Pacientes Con Colelitiasis sintomática y régimen de cirugía Sin Ingreso.
- ClinicalTrials.gov ID
- NCT02375529
- Acronym / sponsor ID
- 11/19
- Conditions
- Cholelithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Mar 2015 (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.
Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.
Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Incision Cholesystectomy (SILC) | Experimental | Procedure: Single Incision Laparoscopic Cholecystectomy (SILC)Single Incision Laparoscopic Cholecystectomy (SILC): The umbilicus is grasped and a 2 cm vertical skin and fascial incision is performed. A multiport (TriPort®) is inserted under direct vision. Principles of cholecystectomy are the same as traditional laparoscopic cholecystectomy. |
| Four Ports Cholecystectomy (4PCL) | Active comparator | Procedure: Four Ports Laparoscopic Cholecystectomy (4PLC)Four Ports Conventional laparoscopic cholecystectomy (4PCL): A 10mm supraumbilical incision is made and the pneumoperitoneum insufflated through a Veress needle. 4 ports are introduced: 2 of 10mm in supraumbilical and left flank and 2 of 5mm in epigastric and right flank. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age higher than 18 and lower than 80
- American Society of Anesthesiologists class (ASA) I-II,
- absence of any previous anesthetic complication,
- accompaniment by a responsible adult during 24 hours,
- symptomatic gallstones candidate to cholecystectomy
Key exclusion criteria (5 listed)
- a Body Mass Index (BMI) higher than 35,
- any laparoscopic contraindication,
- acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
- anti-inflammatory allergy
- psychiatric history that could hinder ambulatory procedure
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 |
|---|---|---|
| Single Incision Laparoscopic Cholecystectomy (SILC)A 2.5-cm incision is made through the everted umbilicus down to the midline fascia, and through the fascia and the peritoneum. The multichannel port (Olympus) is introduced. Carbon dioxide is insufflated (12 mmHg) and a 30 degree 10-mm laparoscope is introduced. The operating table is put in the reverse Trendelenburg position (20 degrees), left side down. A pre-curved grasper and the monopolar electrocautery are introduced through the other 2 ports of the trocar and the dissection of the gallbladder starts in a retrograde manner. The triangle of Calot is exposed, the cystic duct and artery are separately dissected and ligated with 5 mm clips. The monopolar electrocautery is used to remove the gallbladder from the liver bed. The gallbladder is removed along with the port system from the abdominal cavity. The fascia at the port site is closed and the umbilicus is inverted. | Procedure or surgery | Single Incision Cholesystectomy (SILC) |
| Four Ports Laparoscopic Cholecystectomy (4PLC)An 11-mm periumbilical port, a 10-mm left upper quadrant port , 5mm subxyphoid port, and 5-mm right lower quadrant port were used in 4-port LC. We adopted the single surgeon technique in the 4-port LC using 30-degree operating telescopes that was inserted into the umbilical port. Retraction of the gallbladder was done by the long grasping forceps through the 5-mm right lower quadrant port, whereas dissection was accomplished through the 10-mm left upper quadrant port. The cystic duct and cystic artery were clipped by a 5-mm multiple clip applicator. The gallbladder was retrieved through the umbilical port after the position of the operating telescope was changed. Nontransparent surgical adhesive tape was applied to the standard 4-port sites at the end of the operation . | Procedure or surgery | Four Ports Cholecystectomy (4PCL) |
Primary outcome
evolution of postoperative pain
Time frame: 2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery
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 2 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Single Incision Laparoscopic Cholecystectomy (SILC) and Four Ports Laparoscopic Cholecystectomy (4PLC) in people with Cholelithiasis, run by Consorci Sanitari Integral.
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 5 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 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
evolution of postoperative pain (time frame: 2, 4, 6 and 8 postoperative hours, 1, 3, 7 and 30 days after surgery). 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 2 Mar 2015.