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This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG).
There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus.
During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViSiGi® 3D suction calibration device | Experimental | The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing. |
|
| Esophagogastroduodenoscopy (EGD) calibration | Active Comparator | Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViSiGi® 3D suction calibration device | Device | ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Staple Load Firings | Staple usage will be recorded during the weight loss surgery procedure. | During sleeve gastrectomy (up to 5 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Duration (Time) | Surgery start and completion time will be recorded, and operative duration will be calculated | During sleeve gastrectomy (up to 5 hours) |
| Intra-operative Cost for Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Hechenbleikner, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30322 | United States |
The study team does not plan to make the data available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | ViSiGi® 3D Suction Calibration Device | The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing. ViSiGi® 3D suction calibration device: ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. |
| FG001 | Esophagogastroduodenoscopy (EGD) Calibration | Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ViSiGi® 3D Suction Calibration Device | The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing. ViSiGi® 3D suction calibration device: ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Staple Load Firings | Staple usage will be recorded during the weight loss surgery procedure. | Posted | Mean | Standard Deviation | Number of staples | During sleeve gastrectomy (up to 5 hours) |
|
From date of surgery up to 12 months post-operatively (+/- 12 - 24 months).
The PI will be informed of serious adverse events (AEs) as soon as they occur by Co-Investigators (i.e.,surgeons performing sleeve gastrectomy) and/or the study coordinator and notify the Medical board (MB) within 48 hours of becoming aware of the event. The PI will report serious AEs and unanticipated problems (UPs) to his or her IRB within 5 business days of becoming aware of the event. Data collection for Adverse events is still ongoing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ViSiGi® 3D Suction Calibration Device | The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing. ViSiGi® 3D suction calibration device: ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Hechenbleikner | Emory University | 404-778-3712 | elizabeth.hechenbleikner@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2021 | Jan 31, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D002138 | Calibration |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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|
| Esophagogastroduodenoscopy (EGD) calibration | Device | Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy. |
|
Cost data (administrative data) will be retrieved from internal database
| During sleeve gastrectomy (up to 5 hours) |
| GERD Symptom Severity Score | GERD-HRQL questionnaire will be administered pre-operatively and post-operatively. The instrument contains a total of 10 scaled items which are scored, and a patient-reported global satisfaction assessment which is not added to the total GERD-HRQL score. Higher score correlates with worse outcome. Scale: No symptoms = 0; Symptoms noticeable, but not bothersome = 1; Symptoms noticeable and bothersome, but not every day = 2; Symptoms bothersome every day = 3; Symptoms affect daily activities = 4; Symptoms are incapacitating, unable to do daily activities = 5 | 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) |
| Body Weight | Total body weight was calculated in Kg. | 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) |
| BG001 | Esophagogastroduodenoscopy (EGD) Calibration | Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean total body weight at 1-2 months prior to surgery | Number analyzed in row differs from overall because there was one pre-op weight missing in each group. | Mean | Standard Deviation | Kg |
|
| OG001 | Esophagogastroduodenoscopy (EGD) Calibration | Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy. |
|
|
| Secondary | Operative Duration (Time) | Surgery start and completion time will be recorded, and operative duration will be calculated | Posted | Mean | Standard Deviation | minutes | During sleeve gastrectomy (up to 5 hours) |
|
|
|
| Secondary | Intra-operative Cost for Patients | Cost data (administrative data) will be retrieved from internal database | Data for this study outcome was not collected due to internal limitations of the study. | Posted | During sleeve gastrectomy (up to 5 hours) |
|
|
| Secondary | GERD Symptom Severity Score | GERD-HRQL questionnaire will be administered pre-operatively and post-operatively. The instrument contains a total of 10 scaled items which are scored, and a patient-reported global satisfaction assessment which is not added to the total GERD-HRQL score. Higher score correlates with worse outcome. Scale: No symptoms = 0; Symptoms noticeable, but not bothersome = 1; Symptoms noticeable and bothersome, but not every day = 2; Symptoms bothersome every day = 3; Symptoms affect daily activities = 4; Symptoms are incapacitating, unable to do daily activities = 5 | Number of participants analyzed only included patients that were able to complete the questionnaire at each time point, which is different for each follow up. | Posted | Mean | Standard Deviation | score on a scale | 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) |
|
|
|
| Secondary | Body Weight | Total body weight was calculated in Kg. | Unable to get reliable weight loss data for the early post-op time frame for 3 weeks post-operatively (+/- 2 weeks). Number of participants analyzed for the long-term follow up included patients that completed the appointment including weight check. | Posted | Mean | Standard Deviation | Kg | 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) |
|
|
|
| 2 |
| 50 |
| 2 |
| 50 |
| 0 |
| 50 |
| EG001 | Esophagogastroduodenoscopy (EGD) Calibration | Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy. | 0 | 56 | 0 | 56 | 0 | 56 |
| Cerebral Accident | Nervous system disorders | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| GERD-HRQL Score at 3 weeks post-operatively (+/- 2 weeks) |
|
|
| GERD-HRQL Score at 12 months post-operatively (+/- 12 - 24 months) |
|
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