CholelithiasisPhase 4NCT01397565
Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy
A Phase 4 study testing Laparoscopic cholecystectomy and Minilaparoscopic cholecystectomy in people with Cholelithiasis and Cholecystectomy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Laparoscopic cholecystectomy is one of the most commonly performed operations in general surgery and is considered the standard of care for cholecystectomy for benign biliary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis, Cholecystectomy
- What is being tested?
- Laparoscopic cholecystectomy and Minilaparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Sep 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum 18 years of age
- referred for elective cholecystectomy for benign biliary stone disease
Who cannot join
- previous upper gastrointestinal surgery
- acute cholecystitis (past or present)
- American Society of Anesthesiologists (ASA) class greater than or equal to 4
- pregnancy
- morbid obesity (BMI > 35 kg/m2)
- inability to comprehend questionnaires in either English or French
- psychiatric conditions that preclude cooperation and/or comprehension of questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy: A Randomized Trial
Laparoscopic cholecystectomy is one of the most commonly performed operations in general surgery and is considered the standard of care for cholecystectomy for benign biliary disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is associated with less postoperative pain, quicker recovery time and an improved cosmetic result.
Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to as needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further reduce postoperative pain and recovery time as well as improve cosmetic results following laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing conventional to minilaparoscopic cholecystectomy.
Read the detailed description
Background Since its introduction in the late 1980's, laparoscopic cholecystectomy has quickly become the standard of care in surgery for benign disease of the gallbladder. When compared to open surgery, laparoscopic surgery is associated with decreased post-operative pain. Recovery time and return to usual activity are also significantly shorter following the laparoscopic procedure. Cholecystectomy in the era of laparoscopic surgery has become an out-patient procedure. Furthermore, laparoscopic surgery eliminates a large surgical scar and provides patients an improved cosmetic result .
Laparoscopic technology has evolved rapidly over the last 20 years. The quality of instruments, and especially of optics, has greatly improved since the first laparoscopic cholecystectomies were performed. A significant trend in the development of new technologies has been the move toward smaller instruments and cameras. Where 10mm cameras were standard in the early years of laparoscopy, 5mm cameras now offer excellent optical quality and permit the use of fewer 10mm trocars. In this movement toward increasingly less invasive techniques, minilaparoscopic surgery has emerged. Minilaparoscopic surgery (also called needlescopic surgery) involves the use of smaller trocars and instruments, typically 3mm in size. It is hypothesized that smaller trocars cause less tissue damage and therefore result in improved post-operative pain and recovery, while offering the additional benefit of improved cosmesis.
Previous studies have found minilaparoscopic surgery to be safe, with complication rates no greater than those of conventional laparoscopic technique. In some studies, minilaparoscopic cholecystectomy has been associated with slightly increased operative time. Previous studies have also noted higher conversion rates (a change in the planned operative technique to another technique), however this conversion is typically from minilaparoscopy to conventional laparoscopy; the rate of conversion from minilaparoscopy to an open procedure is no higher than with conventional laparoscopy. However a recent meta-analysis performed by Thakur et al. (1) found that while some studies have shown these trends toward longer operative times and increased conversion rates, the overall evidence for this is weak.
While a number of previous studies have attempted evaluate the benefits that patients derive from minilaparoscopic surgery, including post-operative pain and recovery time, many of these studies have been flawed by methodological concerns. Thakur et al showed in their meta-analysis that minilaparoscopic cholecystectomy was associated with improved cosmesis at one month as well as reduced post-operative pain and faster recovery time. These benefits however were estimated to be minimal based on the available evidence. Unclear reporting of trials and flawed study design, specifically the lack of "intention to treat" analysis, make the interpretation of available data difficult and the meta-analysis concluded that "the evidence for using minicholecystecomy is unclear."
More high quality evidence is needed for the surgical community to determine the utility and benefits of minilaparoscopic cholecystectomy. It is our hope that through a rigorous methodological design we can add to the available literature and determine if minilaparoscopic cholecystectomy is a valuable technique that will benefit patients.
Hypothesis Minilaparoscopic surgery will reduce postoperative pain and recovery time, as well as improve cosmetic results in patients undergoing cholecystectomy.
Objectives
A randomized trial comparing minilaparoscopic cholecystectomy to standard laparoscopic cholecystectomy will be performed to:
- Determine if minilaparoscopic surgery is associated with decreased postoperative pain
- Determine if minilaparoscopic surgery results is associated with quicker recovery and return to usual activities
- Determine if minilaparoscopic surgery is associated with in an improved cosmetic result
- Conditions
- Cholelithiasis, Cholecystectomy
- Being tested
- Laparoscopic cholecystectomy, Minilaparoscopic cholecystectomy
- Keywords
- Cholecystectomy, Laparoscopy, Minilaparoscopic surgery, Post-operative pain, Recovery time
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
Minilaparoscopic cholecystectomyProcedure or surgery
Also called Needlescopic surgery
Laparoscopic cholecystectomy performed using minilaparoscopic instruments
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic cholecystectomy | Active comparator | Patients in this arm will undergo conventional laparoscopic cholecystectomy Receives: Procedure: Laparoscopic cholecystectomy |
| Minilaparoscopic cholecystectomy | Experimental | Patients in this arm will undergo laparoscopic cholecystectomy using minilaparoscopic instruments Receives: Procedure: Minilaparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain will be assessed during the first week post-operatively using a diary that will be provided to patients. In this diary, patients will score their pain daily using a visual analog scale (0=no pain and 10=severe pain) and record use of pain medications for the first seven days post-operatively. Patients will again be asked to score their pain using the visual analog scale at the regularly scheduled follow-up visit three weeks post-op.
Measured: First seven days post-op, 3 weeks post-op
Time to recovery
Time to recovery (return to baseline level of activity) will be evaluated by comparing baseline physical activity scores to physical activity scores determined at the follow-up visit three weeks post-op. Physical activity scores will be obtained using the validated CHAMPS questionnaire (2)
Measured: 3 weeks post-operatively
Cosmetic result
Cosmetic result will be evaluated using a scar assessment questionnaire (3), that will be administered by the study coordinator at the routine post-op visit as well as at three months by telephone
Measured: 3 months post-operatively
Secondary outcomes (3)
Operative complications
Intra-operative, in-hospital (if applicable) and postoperative complications will be recorded and graded according to the Clavien Classification. Superficial and deep incisional surgical site infections will be defined according to the CDC definition.
Measured: First 3 months post-op
Operative technique
Conversion to conventional laparoscopic technique or open procedure will be recorded at the time of operation.
Measured: Recorded at visit 3 weeks post-op
Length of operation
The time necessary to complete the intervention will be recorded
Measured: Recorded at visit 3 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2015
- Study completionSep 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Liane Feldman, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397565
- Sponsor's protocol ID
- 11-053-SDR
- Status last verified
- Sep 2015
- First submitted
- 5 Jul 2011
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thakur V, Schlachta CM, Jayaraman S. Minilaparoscopic versus conventional laparoscopic cholecystectomy a systematic review and meta-analysis. Ann Surg. 2011 Feb;253(2):244-58. doi: 10.1097/SLA.0b013e318207bf52.
PubMed 21183848Feldman LS, Kaneva P, Demyttenaere S, Carli F, Fried GM, Mayo NE. Validation of a physical activity questionnaire (CHAMPS) as an indicator of postoperative recovery after laparoscopic cholecystectomy. Surgery. 2009 Jul;146(1):31-9. doi: 10.1016/j.surg.2009.02.019.
PubMed 19541008Durani P, McGrouther DA, Ferguson MW. The Patient Scar Assessment Questionnaire: a reliable and valid patient-reported outcomes measure for linear scars. Plast Reconstr Surg. 2009 May;123(5):1481-1489. doi: 10.1097/PRS.0b013e3181a205de.
PubMed 19407619Alhashemi M, Almahroos M, Fiore JF Jr, Kaneva P, Gutierrez JM, Neville A, Vassiliou MC, Fried GM, Feldman LS. Impact of miniport laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy on recovery of physical activity: a randomized trial. Surg Endosc. 2017 May;31(5):2299-2309. doi: 10.1007/s00464-016-5232-z. Epub 2016 Sep 21.
PubMed 27655375
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01397565
- Acronym / sponsor ID
- 11-053-SDR
- Conditions
- Cholelithiasis, Cholecystectomy
- Keywords
- Cholecystectomy, Laparoscopy, Minilaparoscopic surgery, Post-operative pain, Recovery time
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jul 2011 (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 is one of the most commonly performed operations in general surgery and is considered the standard of care for cholecystectomy for benign biliary disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is associated with less postoperative pain, quicker recovery time and an improved cosmetic result.
Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to as needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further reduce postoperative pain and recovery time as well as improve cosmetic results following laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing conventional to minilaparoscopic cholecystectomy.
Detailed description
Background Since its introduction in the late 1980's, laparoscopic cholecystectomy has quickly become the standard of care in surgery for benign disease of the gallbladder. When compared to open surgery, laparoscopic surgery is associated with decreased post-operative pain. Recovery time and return to usual activity are also significantly shorter following the laparoscopic procedure. Cholecystectomy in the era of laparoscopic surgery has become an out-patient procedure. Furthermore, laparoscopic surgery eliminates a large surgical scar and provides patients an improved cosmetic result .
Laparoscopic technology has evolved rapidly over the last 20 years. The quality of instruments, and especially of optics, has greatly improved since the first laparoscopic cholecystectomies were performed. A significant trend in the development of new technologies has been the move toward smaller instruments and cameras. Where 10mm cameras were standard in the early years of laparoscopy, 5mm cameras now offer excellent optical quality and permit the use of fewer 10mm trocars. In this movement toward increasingly less invasive techniques, minilaparoscopic surgery has emerged. Minilaparoscopic surgery (also called needlescopic surgery) involves the use of smaller trocars and instruments, typically 3mm in size. It is hypothesized that smaller trocars cause less tissue damage and therefore result in improved post-operative pain and recovery, while offering the additional benefit of improved cosmesis.
Previous studies have found minilaparoscopic surgery to be safe, with complication rates no greater than those of conventional laparoscopic technique. In some studies, minilaparoscopic cholecystectomy has been associated with slightly increased operative time. Previous studies have also noted higher conversion rates (a change in the planned operative technique to another technique), however this conversion is typically from minilaparoscopy to conventional laparoscopy; the rate of conversion from minilaparoscopy to an open procedure is no higher than with conventional laparoscopy. However a recent meta-analysis performed by Thakur et al. (1) found that while some studies have shown these trends toward longer operative times and increased conversion rates, the overall evidence for this is weak.
While a number of previous studies have attempted evaluate the benefits that patients derive from minilaparoscopic surgery, including post-operative pain and recovery time, many of these studies have been flawed by methodological concerns. Thakur et al showed in their meta-analysis that minilaparoscopic cholecystectomy was associated with improved cosmesis at one month as well as reduced post-operative pain and faster recovery time. These benefits however were estimated to be minimal based on the available evidence. Unclear reporting of trials and flawed study design, specifically the lack of "intention to treat" analysis, make the interpretation of available data difficult and the meta-analysis concluded that "the evidence for using minicholecystecomy is unclear."
More high quality evidence is needed for the surgical community to determine the utility and benefits of minilaparoscopic cholecystectomy. It is our hope that through a rigorous methodological design we can add to the available literature and determine if minilaparoscopic cholecystectomy is a valuable technique that will benefit patients.
Hypothesis Minilaparoscopic surgery will reduce postoperative pain and recovery time, as well as improve cosmetic results in patients undergoing cholecystectomy.
Objectives
A randomized trial comparing minilaparoscopic cholecystectomy to standard laparoscopic cholecystectomy will be performed to:
- Determine if minilaparoscopic surgery is associated with decreased postoperative pain
- Determine if minilaparoscopic surgery results is associated with quicker recovery and return to usual activities
- Determine if minilaparoscopic surgery is associated with in an improved cosmetic result
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyPatients in this arm will undergo conventional laparoscopic cholecystectomy |
| Minilaparoscopic cholecystectomy | Experimental | Procedure: Minilaparoscopic cholecystectomyPatients in this arm will undergo laparoscopic cholecystectomy using minilaparoscopic instruments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- minimum 18 years of age
- referred for elective cholecystectomy for benign biliary stone disease
Key exclusion criteria (7 listed)
- previous upper gastrointestinal surgery
- acute cholecystitis (past or present)
- American Society of Anesthesiologists (ASA) class greater than or equal to 4
- pregnancy
- morbid obesity (BMI > 35 kg/m2)
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 |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | Laparoscopic cholecystectomy |
| Minilaparoscopic cholecystectomyAlso: Needlescopic surgeryLaparoscopic cholecystectomy performed using minilaparoscopic instruments | Procedure or surgery | Minilaparoscopic cholecystectomy |
Primary outcome
Post-operative pain
Time frame: First seven days post-op, 3 weeks post-op
Post-operative pain will be assessed during the first week post-operatively using a diary that will be provided to patients. In this diary, patients will score their pain daily using a visual analog scale (0=no pain and 10=severe pain) and record use of pain medications for the first seven days post-operatively. Patients will again be asked to score their pain using the visual analog scale at the regularly scheduled follow-up visit three weeks post-op.
Time to recovery
Time frame: 3 weeks post-operatively
Time to recovery (return to baseline level of activity) will be evaluated by comparing baseline physical activity scores to physical activity scores determined at the follow-up visit three weeks post-op. Physical activity scores will be obtained using the validated CHAMPS questionnaire (2)
Cosmetic result
Time frame: 3 months post-operatively
Cosmetic result will be evaluated using a scar assessment questionnaire (3), that will be administered by the study coordinator at the routine post-op visit as well as at three months by telephone
3 secondary outcomes
Operative complications
Time frame: First 3 months post-op
Operative technique
Time frame: Recorded at visit 3 weeks post-op
Length of operation
Time frame: Recorded at visit 3 weeks post-op
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 29 Sep 2015.
- Background: PubMed 21183848Thakur V, Schlachta CM, Jayaraman S. Minilaparoscopic versus conventional laparoscopic cholecystectomy a systematic review and meta-analysis. Ann Surg. 2011 Feb;253(2):244-58. doi: 10.1097/SLA.0b013e318207bf52.
- Background: PubMed 19541008Feldman LS, Kaneva P, Demyttenaere S, Carli F, Fried GM, Mayo NE. Validation of a physical activity questionnaire (CHAMPS) as an indicator of postoperative recovery after laparoscopic cholecystectomy. Surgery. 2009 Jul;146(1):31-9. doi: 10.1016/j.surg.2009.02.019.
- Background: PubMed 19407619Durani P, McGrouther DA, Ferguson MW. The Patient Scar Assessment Questionnaire: a reliable and valid patient-reported outcomes measure for linear scars. Plast Reconstr Surg. 2009 May;123(5):1481-1489. doi: 10.1097/PRS.0b013e3181a205de.
- Derived from this study: PubMed 27655375Alhashemi M, Almahroos M, Fiore JF Jr, Kaneva P, Gutierrez JM, Neville A, Vassiliou MC, Fried GM, Feldman LS. Impact of miniport laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy on recovery of physical activity: a randomized trial. Surg Endosc. 2017 May;31(5):2299-2309. doi: 10.1007/s00464-016-5232-z. Epub 2016 Sep 21.
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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.
Liane Feldman, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic cholecystectomy and Minilaparoscopic cholecystectomy in people with Cholelithiasis and Cholecystectomy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 2 inclusion and 7 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 29 Sep 2015. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Post-operative pain (time frame: First seven days post-op, 3 weeks post-op). The study lists 3 primary outcomes in all. 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 NCT01397565, 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 29 Sep 2015.