Gastrectomy, Obesity
Conditions
Keywords
weight loss surgery, laparoscopic sleeve gastrectomy, suction calibration system, bariatric surgery
Brief summary
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).
Detailed description
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.
Interventions
DEVICEViSiGi® 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.
DEVICEEsophagogastroduodenoscopy (EGD) calibration
Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice
Exclusion criteria
* Had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy) * Concomitant hiatal surgery * Paraesophageal hernia at time of surgery * Any subject with prescribed immunosuppressive drugs. * In the opinion of investigator, subject is not eligible to participate in the study. * If patient is a female and becomes pregnant at any time during the study duration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Staple Load Firings | During sleeve gastrectomy (up to 5 hours) | Staple usage will be recorded during the weight loss surgery procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Duration (Time) | During sleeve gastrectomy (up to 5 hours) | Surgery start and completion time will be recorded, and operative duration will be calculated |
| Intra-operative Cost for Patients | During sleeve gastrectomy (up to 5 hours) | Cost data (administrative data) will be retrieved from internal database |
| GERD Symptom Severity Score | 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) | 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 |
| Body Weight | 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) | Total body weight was calculated in Kg. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 56 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
Baseline characteristics
| Characteristic | ViSiGi® 3D Suction Calibration Device | Esophagogastroduodenoscopy (EGD) Calibration | Total |
|---|---|---|---|
| Age, Continuous | 42.80 years STANDARD_DEVIATION 11.14 | 43.90 years STANDARD_DEVIATION 12.13 | 43.38 years STANDARD_DEVIATION 11.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 47 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 9 Participants | 18 Participants |
| Mean total body weight at 1-2 months prior to surgery | 138.1 Kg STANDARD_DEVIATION 28.7 | 135.7 Kg STANDARD_DEVIATION 27.8 | 137.0 Kg STANDARD_DEVIATION 29.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 39 Participants | 73 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 13 Participants | 15 Participants | 28 Participants |
| Region of Enrollment United States | 50 participants | 56 participants | 106 participants |
| Sex: Female, Male Female | 42 Participants | 47 Participants | 89 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 50 | 0 / 56 |
| other Total, other adverse events | 0 / 50 | 0 / 56 |
| serious Total, serious adverse events | 2 / 50 | 0 / 56 |
Outcome results
Primary
Number of Staple Load Firings
Staple usage will be recorded during the weight loss surgery procedure.
Time frame: During sleeve gastrectomy (up to 5 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ViSiGi® 3D Suction Calibration Device | Number of Staple Load Firings | 5.26 Number of staples | Standard Deviation 0.78 |
| Esophagogastroduodenoscopy (EGD) Calibration | Number of Staple Load Firings | 5.42 Number of staples | Standard Deviation 0.89 |
Secondary
Body Weight
Total body weight was calculated in Kg.
Time frame: 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViSiGi® 3D Suction Calibration Device | Body Weight | Body weight at 12 months post-operatively (+/- 12 - 24 months) | 108.2 Kg | Standard Deviation 24.9 |
| Esophagogastroduodenoscopy (EGD) Calibration | Body Weight | Body weight at 12 months post-operatively (+/- 12 - 24 months) | 106.7 Kg | Standard Deviation 24.5 |
| Unknown | Body Weight | Body weight at 3 weeks post-operatively (+/- 2 weeks) | — Kg | — |
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
Time frame: 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViSiGi® 3D Suction Calibration Device | GERD Symptom Severity Score | GERD-HRQL Score at 12 months post-operatively (+/- 12 - 24 months) | 2.58 score on a scale | Standard Deviation 4.15 |
| ViSiGi® 3D Suction Calibration Device | GERD Symptom Severity Score | GERD-HRQL Score at 1-2 months prior to surgery | 4.54 score on a scale | Standard Deviation 5.7 |
| ViSiGi® 3D Suction Calibration Device | GERD Symptom Severity Score | GERD-HRQL Score at 3 weeks post-operatively (+/- 2 weeks) | 3.00 score on a scale | Standard Deviation 4.33 |
| Esophagogastroduodenoscopy (EGD) Calibration | GERD Symptom Severity Score | GERD-HRQL Score at 3 weeks post-operatively (+/- 2 weeks) | 5.66 score on a scale | Standard Deviation 9.56 |
| Esophagogastroduodenoscopy (EGD) Calibration | GERD Symptom Severity Score | GERD-HRQL Score at 12 months post-operatively (+/- 12 - 24 months) | 2.64 score on a scale | Standard Deviation 3.79 |
| Esophagogastroduodenoscopy (EGD) Calibration | GERD Symptom Severity Score | GERD-HRQL Score at 1-2 months prior to surgery | 3.82 score on a scale | Standard Deviation 5.67 |
Secondary
Intra-operative Cost for Patients
Cost data (administrative data) will be retrieved from internal database
Time frame: During sleeve gastrectomy (up to 5 hours)
Population: Data for this study outcome was not collected due to internal limitations of the study.
Secondary
Operative Duration (Time)
Surgery start and completion time will be recorded, and operative duration will be calculated
Time frame: During sleeve gastrectomy (up to 5 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ViSiGi® 3D Suction Calibration Device | Operative Duration (Time) | 93.38 minutes | Standard Deviation 28.1 |
| Esophagogastroduodenoscopy (EGD) Calibration | Operative Duration (Time) | 94.42 minutes | Standard Deviation 36.5 |