Cholecystectomy, LaparoscopicNCT01094379
A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy
A study testing Standard laparoscopic cholecystectomy and Single incision laparoscopic cholecystectomy in people with Cholecystectomy, Laparoscopic, run by University of Athens at 1 site in Greece.
Trial summary
Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Standard laparoscopic cholecystectomy and Single incision laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Apr 2011
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with symptomatic cholelithiasis, admitted for laparoscopic cholecystectomy
Who cannot join
- Patients with acute cholecystitis
- Patients with extensive upper abdominal incisions
- Patients with body mass index >30
- Patients on regular analgesic medication
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Academic Department of Surgery, Aretaieion Hospital
Athens, 11528
Antonios Vezakis, Lecturer
George Polymeneas, Professor
About this study
Official title: A Randomised Comparison of Postoperative Pain and Recovery Between Single Incision Laparoscopic Cholecystectomy Using One Port and Standard Laparoscopic Cholecystectomy Using Four Ports
Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, especially for planned day case procedures.
Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same umbilical incision. The single incision laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and safe by several studies.
The purpose of the study is to compare postoperative pain and operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS and standard laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, especially for planned day case procedures.
Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same umbilical incision. The single incision laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and safe by several studies. However, there is not for the moment any randomized study between standard and SILS cholecystectomy published.
The primary end point of the study is to compare postoperative pain and secondary end points operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result and quality of life.
Patients admitted for laparoscopic cholecystectomy to Aretaieion Hospital, under the care of four surgeons, will be entered into the study after signed consent is obtained. Randomization will be carried out preoperatively using blocks of random numbers. Anaesthesia will be standardized.
The same waterproof dressings, at the same sites, will be applied in all patients in order to prevent nursing and other staff from knowing what variant of operation has been carried out.
Postoperatively, all patients will receive and identical protocol of care. Postoperative pain will be assessed using a visual analogue pain score. The same analgesia will be prescribed in all the patients, if required. Postoperative analgesia, nausea or vomiting will be recorded.
Pulmonary function tests will be measured, in the sitting position, using a spirometer before and after the operation.
Tissue damage will be assessed by measuring CRP and Interleukin-6 (IL-6). Injury or inflammation of the human body results in increased concentrations of the acute-phase reactant proteins. CRP is very consistent in response and is, therefore, the most satisfactory single screening test for an acute phase reactant. IL-6 is one of the most important mediators of the acute phase response. It is secreted by T cells and macrophages to stimulate immune response to trauma.
The cosmetic result will be assessed by the patient.
Quality-of-life will be assessed using the EuroQoL EQ-5D questionnaire preoperatively and at 1 week postoperatively. The EQ-5D questionnaire is a generic measure of the quality of life, in which health status is defined in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Reevaluation of the patients will take place 1 week and 4 weeks after the operation in the outpatient clinic.
If we consider that we reduce postoperative pain at 35%, then with α: 0.05 and β: 0.20 we need 20 patients in each arm.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Standard laparoscopic cholecystectomy, Single incision laparoscopic cholecystectomy
- Keywords
- cholecystectomy, laparoscopic, pain, single incision
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard laparoscopic cholecystectomyProcedure or surgery
Also called Traditional laparoscopic cholecystectomy
Laparoscopic cholecystectomy using four entry sites to the abdominal cavity
Single incision laparoscopic cholecystectomyProcedure or surgery
Also called One port laparoscopic cholecystectomy
Laparoscopic cholecystectomy using one entry site to the abdominal cavity
| Study group | Role | What they receive |
|---|---|---|
| Standard lap chole | Active comparator | Laparoscopic cholecystectomy using four entry sites to the abdominal cavity Receives: Procedure: Standard laparoscopic cholecystectomy |
| Single incision lap chole | Active comparator | Laparoscopic cholecystectomy using one entry site to the abdominal cavity Receives: Procedure: Single incision laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed using a visual analogue pain score
Measured: 24h
Secondary outcomes (6)
operating time
Measured: Duration of surgical procedure
nausea or vomiting
Measured: 24 h
tissue damage
Measured: 24h
pulmonary function
Measured: 24h
cosmetic result
Measured: 4 weeks
Quality of life questionnaire
Quality-of-life will be assessed using the EuroQoL EQ-5D questionnaire preoperatively and 1 week postoperatively. The EQ-5D questionnaire is a generic measure of the quality of life, in which health status is defined in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Investigators
- Antonios Vezakis, lecturer, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094379
- Sponsor's protocol ID
- Aretaieion01
- Status last verified
- Jun 2010
- First submitted
- 23 Mar 2010
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25.
PubMed 18815836Chow A, Purkayastha S, Aziz O, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: an evolving technique. Surg Endosc. 2010 Mar;24(3):709-14. doi: 10.1007/s00464-009-0655-4. Epub 2009 Aug 18.
PubMed 19688389Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.
PubMed 21910897
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Comparison of Postoperative Pain and Recovery Between Single Incision Laparoscopic Cholecystectomy Using One Port and Standard Laparoscopic Cholecystectomy Using Four Ports
- ClinicalTrials.gov ID
- NCT01094379
- Acronym / sponsor ID
- Aretaieion01
- Conditions
- Cholecystectomy, Laparoscopic
- Keywords
- cholecystectomy, laparoscopic, pain, single incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 26 Mar 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.
Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, especially for planned day case procedures.
Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same umbilical incision. The single incision laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and safe by several studies.
The purpose of the study is to compare postoperative pain and operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS and standard laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, especially for planned day case procedures.
Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same umbilical incision. The single incision laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and safe by several studies. However, there is not for the moment any randomized study between standard and SILS cholecystectomy published.
The primary end point of the study is to compare postoperative pain and secondary end points operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result and quality of life.
Patients admitted for laparoscopic cholecystectomy to Aretaieion Hospital, under the care of four surgeons, will be entered into the study after signed consent is obtained. Randomization will be carried out preoperatively using blocks of random numbers. Anaesthesia will be standardized.
The same waterproof dressings, at the same sites, will be applied in all patients in order to prevent nursing and other staff from knowing what variant of operation has been carried out.
Postoperatively, all patients will receive and identical protocol of care. Postoperative pain will be assessed using a visual analogue pain score. The same analgesia will be prescribed in all the patients, if required. Postoperative analgesia, nausea or vomiting will be recorded.
Pulmonary function tests will be measured, in the sitting position, using a spirometer before and after the operation.
Tissue damage will be assessed by measuring CRP and Interleukin-6 (IL-6). Injury or inflammation of the human body results in increased concentrations of the acute-phase reactant proteins. CRP is very consistent in response and is, therefore, the most satisfactory single screening test for an acute phase reactant. IL-6 is one of the most important mediators of the acute phase response. It is secreted by T cells and macrophages to stimulate immune response to trauma.
The cosmetic result will be assessed by the patient.
Quality-of-life will be assessed using the EuroQoL EQ-5D questionnaire preoperatively and at 1 week postoperatively. The EQ-5D questionnaire is a generic measure of the quality of life, in which health status is defined in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Reevaluation of the patients will take place 1 week and 4 weeks after the operation in the outpatient clinic.
If we consider that we reduce postoperative pain at 35%, then with α: 0.05 and β: 0.20 we need 20 patients in each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard lap chole | Active comparator | Procedure: Standard laparoscopic cholecystectomyLaparoscopic cholecystectomy using four entry sites to the abdominal cavity |
| Single incision lap chole | Active comparator | Procedure: Single incision laparoscopic cholecystectomyLaparoscopic cholecystectomy using one entry site to the abdominal cavity |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic cholelithiasis, admitted for laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- Patients with acute cholecystitis
- Patients with extensive upper abdominal incisions
- Patients with body mass index >30
- Patients on regular analgesic medication
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 |
|---|---|---|
| Standard laparoscopic cholecystectomyAlso: Traditional laparoscopic cholecystectomyLaparoscopic cholecystectomy using four entry sites to the abdominal cavity | Procedure or surgery | Standard lap chole |
| Single incision laparoscopic cholecystectomyAlso: One port laparoscopic cholecystectomyLaparoscopic cholecystectomy using one entry site to the abdominal cavity | Procedure or surgery | Single incision lap chole |
Primary outcome
Postoperative pain
Time frame: 24h
Postoperative pain will be assessed using a visual analogue pain score
6 secondary outcomes
operating time
Time frame: Duration of surgical procedure
nausea or vomiting
Time frame: 24 h
tissue damage
Time frame: 24h
pulmonary function
Time frame: 24h
cosmetic result
Time frame: 4 weeks
Quality of life questionnaire
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
- Background: PubMed 18815836Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25.
- Background: PubMed 19688389Chow A, Purkayastha S, Aziz O, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: an evolving technique. Surg Endosc. 2010 Mar;24(3):709-14. doi: 10.1007/s00464-009-0655-4. Epub 2009 Aug 18.
- Derived from this study: PubMed 21910897Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.
Related trials for Cholecystectomy, Laparoscopic
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
Active, not recruiting
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
Acut Postoperative Pain, Erector Spinae Plane Block
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
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.
Antonios Vezakis, lecturer principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard laparoscopic cholecystectomy and Single incision laparoscopic cholecystectomy in people with Cholecystectomy, Laparoscopic, run by University of Athens at 1 site in Greece.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jun 2010. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonios Vezakis, Lecturer (00306977405605, avezakis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 24h). 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 NCT01094379, which also lists 3 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 25 Jun 2010.