Morbid Obesity, Weight Loss
Conditions
Keywords
Surgical Endoscopy, Morbid Obesity, Weight Loss, Bariatrics, Surgical Revision
Brief summary
Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess body weight loss or regain of weight. For those patients who fail to lose weight after bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment is re-operation and revision. Re-operation of the abdomen carries significant postoperative morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient. The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient.
Detailed description
The most effective weight loss procedures in the United States are both roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)where the majority are performed laparoscopically. Estimated excess body weight loss (EBWL) is \>50% at the end of one year. However, nearly 20% of patients fail to meet the estimated EBWL or they may experience weight gain recidivism. The first step is nutritional counseling, medically supervised diets, and medical therapy. Surgery would be for those who still fail to lose weight despite the aforementioned efforts. It is hypothesized that failure of weight loss for RYGB is gastrojejunostomy (GJ) dilation defined as \>2 cm. Surgical treatment would require revision of this dilation. Unfortunately many of these revision procedures cannot be done laparoscopically given dense intra-abdominal adhesions. This will require conversion to an open surgery in a morbidly obese patient thus raising postoperative morbidity and mortality estimated to range between 15%-50%. The investigators propose to use the endoscopic suturing device designed by Apollo EndoSurgery to decrease the GJ dilation to 5-6 mm thus causing restriction, delayed food transit time, and promote early satiety. These efforts will limit overall caloric intake thereby promoting weight loss. It is thought that patients with previous SG may have a dilation of their stomach. The investigators propose a pyloric cerclage using the Apollo EndoSurgery suturing device by decreasing the opening of the pylorus thus achieving the same goals that the investigators proposed above with RYGB revision. Endoscopic procedures are same day procedures with little morbidity and mortality when compared to laparoscopic or open bariatric surgery revision.
Interventions
DEVICEEndoscopic Suturing to Create Early Satiety
Evaluating the efficacy of endoscopic suturing for weight loss.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Previous Roux-En-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) * Failure to lose \>50% of their excess body weight after 1 year * Failure of weight loss despite maximal medical therapy and medically-supervised diets
Exclusion criteria
* Esophageal Stricture * Marginal Ulcer at the gastrojejunostomy anastomosis * Non-compliance with bariatric follow-up * Gastric ulcers * Paraesophageal hernias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weight Loss | 3 months after procedure | We will track patient's weight after their endoscopic bariatric surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 2 years | We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire. |
| Number of Participants With Resolved Co-morbidities | 2 years | We will track the patient's weight loss and see if their obesity-related co-morbidities resolve. |
Countries
United States
Participant flow
Pre-assignment details
24 patients were recruited 23 underwent the proposed procedure
Participants by arm
| Arm | Count |
|---|---|
| Weight Gain Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.
Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Weight Gain |
|---|---|
| Age, Continuous | 47.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 24 |
| other Total, other adverse events | 1 / 24 |
| serious Total, serious adverse events | 1 / 24 |
Outcome results
Primary
Mean Weight Loss
We will track patient's weight after their endoscopic bariatric surgery.
Time frame: 3 months after procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Study Participants | Mean Weight Loss | 13.3 Pounds |
Secondary
Number of Participants With Resolved Co-morbidities
We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Number of Participants With Resolved Co-morbidities | 23 Participants |
Secondary
Tolerance
We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.
Time frame: 2 years
Population: Data were not collected for this outcome measure. Milestone visit dates at which surveys were going to be provided were not followed through by patients resulting in the lack of data collected.