CHOLELITHIASISCENoMIPNCT01489436
A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal
A study testing Single-port cholecystectomy and Four-port laparoscopic cholecystectomy in people with CHOLELITHIASIS, run by Mayo Clinic at 1 site in United States.
Trial summary
New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CHOLELITHIASIS
- What is being tested?
- Single-port cholecystectomy and Four-port laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) patients undergoing cholecystectomy in an elective setting for symptomatic gallstone disease.
Who cannot join
- Patients <18 years of age
- Pregnant patients
- Patients with ASA-class >3
- Patients undergoing treatment for chronic pain with opiates
- Patients with biopsy proven gallbladder cancer
- Patients who cannot provide consent for the study
- Patients not willing to participate in the study
- Prisoners/Institutionalized individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Comparative Effectiveness of Novel Minimally Invasive Procedures
New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.
Read the detailed description
To establish a pathway for comparative effectiveness using patient reported outcomes in minimally invasive surgery, we propose to use a readily available and easily reproducible model: cholecystectomy. Each year in the United States, approximately 750,000 patients undergo a cholecystectomy. Patients clearly prefer the laparoscopic approach over the open procedure to abdominal surgery. Initial survey data suggest that patients may also prefer even less invasive approaches.
Currently, the standard operative procedure for a patient with symptomatic gallstone disease is a laparoscopic cholecystectomy performed under general anesthesia with four small abdominal incisions. Although postoperative pain and cardiopulmonary and wound complications are much less compared to open cholecystectomy, considerable cost is generated from lost productivity in days off of work after the surgical procedure related in part to pain and the physiologic response to the stress of the operative procedure. Anecdotal data suggest that fewer incisions, especially fewer transabdominal incisions, translate into less pain, less need for narcotic pain medication and faster recovery, but randomized trial data are needed. We propose to compare the effectiveness of the novel single-port cholecystectomy with laparoscopic cholecystectomy, the current standard of care.
- Conditions
- CHOLELITHIASIS
- Being tested
- Single-port cholecystectomy, Four-port laparoscopic cholecystectomy
- Keywords
- gallstone disease, cholecystectomy, minimally invasive, surgical, laparoscopic, single port, cytokine
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port cholecystectomyProcedure or surgery
Also called Minimally invasive surgery
In brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. This trocar permits simultaneous introduction of multiple instruments, including a 5-mm flexible-tip laparoscope. Standard 5-mm instruments will be used for retraction and dissection. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port.
Four-port laparoscopic cholecystectomyProcedure or surgery
Also called Minimally invasive surgery
The control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder.
| Study group | Role | What they receive |
|---|---|---|
| Single port cholecystectomy | Active comparator | In brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary; this device is placed percutaneously without the need for a trocar. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port, adequate hemostasis is ensured, the umbilical trocar removed, and the single operative site will be closed and sterile dressings applied (four Band-Aids). Receives: Procedure: Single-port cholecystectomy |
| Four-port laparoscopic cholecystectomy | Active comparator | The control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder. Trocar sites will be closed and sterile dressings applied (four Band-Aids). Receives: Procedure: Four-port laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
The investigators will utilize the Patient-Reported Outcomes from the VAS to measure changes from Baseline to day 1 post OP. A 15-mm difference on a 100-mm visual analog scale with a standard deviation of 25 mm at any time point will constitute a clinically relevant difference.
Measured: Baseline to Post Operative day 1
Secondary outcomes (3)
Quality of Life (QOL)
Patients QOL will be measured via Patient-Reported Outcomes Measures Information System (PROMIS) and Linear Analog Self Assessment (LASA) tools.
PROMIS Global Health Short Form and LASA are validated assessment tools. A 2-point difference is considered the minimally important difference in chronic disease for an item in the PROMIS and LASA tools.
Measured: up to 7 days
Heart Rate Variability (HRV) Data
HRV is the bodies' physiological response to pain as measured through digitally captured ECG combined with electronically captured blood pressure.We will measure HRV to determine subtle differences between to the two surgical approaches.
Measured: During surgery from incision to closure
Cytokine levels in blood
Frequently used biomarkers are inflammatory cytokines, specifically the serum levels of the early response pro-inflammatory cytokines TNF-α, Interleukin 1b, Interleukin 6 and Interleukin 8. We will measure and analyze these cytokine levels at set time points to determine if any subtle difference in the levels between the two surgical approaches is significant.
Measured: Baseline, during surgery form incision to closure, 1 hour post OP and 4 hour post OP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CHOLELITHIASISStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliane Bingener-Casey, Mayo Clinic
- Investigators
- Juliane Bingener-Casey, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489436
- Sponsor's protocol ID
- 11-001162
- Acronym
- CENoMIP
- Status last verified
- Mar 2019
- First submitted
- 25 Aug 2011
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bingener J, Skaran P, McConico A, Novotny P, Wettstein P, Sletten DM, Park M, Low P, Sloan J. A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes. J Am Coll Surg. 2015 Jul;221(1):111-21. doi: 10.1016/j.jamcollsurg.2015.02.022. Epub 2015 Mar 3.
PubMed 26095558
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Novel Minimally Invasive Procedures
- ClinicalTrials.gov ID
- NCT01489436
- Acronym / sponsor ID
- CENoMIP / 11-001162
- Conditions
- CHOLELITHIASIS
- Keywords
- gallstone disease, cholecystectomy, minimally invasive, surgical, laparoscopic, single port, cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Dec 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.
New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.
Detailed description
To establish a pathway for comparative effectiveness using patient reported outcomes in minimally invasive surgery, we propose to use a readily available and easily reproducible model: cholecystectomy. Each year in the United States, approximately 750,000 patients undergo a cholecystectomy. Patients clearly prefer the laparoscopic approach over the open procedure to abdominal surgery. Initial survey data suggest that patients may also prefer even less invasive approaches.
Currently, the standard operative procedure for a patient with symptomatic gallstone disease is a laparoscopic cholecystectomy performed under general anesthesia with four small abdominal incisions. Although postoperative pain and cardiopulmonary and wound complications are much less compared to open cholecystectomy, considerable cost is generated from lost productivity in days off of work after the surgical procedure related in part to pain and the physiologic response to the stress of the operative procedure. Anecdotal data suggest that fewer incisions, especially fewer transabdominal incisions, translate into less pain, less need for narcotic pain medication and faster recovery, but randomized trial data are needed. We propose to compare the effectiveness of the novel single-port cholecystectomy with laparoscopic cholecystectomy, the current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single port cholecystectomy | Active comparator | Procedure: Single-port cholecystectomyIn brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary; this device is placed percutaneously without the need for a trocar. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port, adequate hemostasis is ensured, the umbilical trocar removed, and the single operative site will be closed and sterile dressings applied (four Band-Aids). |
| Four-port laparoscopic cholecystectomy | Active comparator | Procedure: Four-port laparoscopic cholecystectomyThe control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder. Trocar sites will be closed and sterile dressings applied (four Band-Aids). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) patients undergoing cholecystectomy in an elective setting for symptomatic gallstone disease.
Key exclusion criteria (8 listed)
- Patients <18 years of age
- Pregnant patients
- Patients with ASA-class >3
- Patients undergoing treatment for chronic pain with opiates
- Patients with biopsy proven gallbladder cancer
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-port cholecystectomyAlso: Minimally invasive surgeryIn brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. This trocar permits simultaneous introduction of multiple instruments, including a 5-mm flexible-tip laparoscope. Standard 5-mm instruments will be used for retraction and dissection. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port. | Procedure or surgery | Single port cholecystectomy |
| Four-port laparoscopic cholecystectomyAlso: Minimally invasive surgeryThe control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder. | Procedure or surgery | Four-port laparoscopic cholecystectomy |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: Baseline to Post Operative day 1
The investigators will utilize the Patient-Reported Outcomes from the VAS to measure changes from Baseline to day 1 post OP. A 15-mm difference on a 100-mm visual analog scale with a standard deviation of 25 mm at any time point will constitute a clinically relevant difference.
3 secondary outcomes
Quality of Life (QOL)
Time frame: up to 7 days
Heart Rate Variability (HRV) Data
Time frame: During surgery from incision to closure
Cytokine levels in blood
Time frame: Baseline, during surgery form incision to closure, 1 hour post OP and 4 hour 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 19 Mar 2019.
- Results publication: PubMed 26095558Bingener J, Skaran P, McConico A, Novotny P, Wettstein P, Sletten DM, Park M, Low P, Sloan J. A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes. J Am Coll Surg. 2015 Jul;221(1):111-21. doi: 10.1016/j.jamcollsurg.2015.02.022. Epub 2015 Mar 3.
- A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.Link provided by the sponsor.
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.
Juliane Bingener-Casey, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-port cholecystectomy and Four-port laparoscopic cholecystectomy in people with CHOLELITHIASIS, run by Mayo Clinic at 1 site in United States.
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 8 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 19 Mar 2019. 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 United States. 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?
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?
Pain Scores on the Visual Analog Scale (time frame: Baseline to Post Operative day 1). 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 NCT01489436, which also lists 1 linked publication.
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 19 Mar 2019.