Description of ROSE Procedure
A new, less invasive surgical option is now available to treat weight regain in gastric bypass patients. If you were originally successful with your bypass surgery but now find yourself regaining some of your lost weight, you may be a candidate for the ROSE procedure (Restorative Obesity Surgery, Endolumenal).
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Your stomach pouch or stoma (the connection between the pouch and small intestine) may have stretched out in the years since your original surgery, reducing the feeling of fullness after you eat.
To resolve this problem, Dr Balder will use new minimally invasive surgical tools. These new tools will create new circumferential suture folds to reduce gastric pouch size (and volume) and can also be used to reduce the anastigmatic or connection size at your gastric pouch outlet - the diameter between your stomach pouch and the small intestine connection. The reduction in pouch size and outlet diameter will decrease hunger, decrease the amount of caloric foods that one can put into their body at any one time, and thus in a restrictive fashion induce weight loss! Dr. Balder will perform the procedure entirely through your open mouth without making any external incisions into the body!
Due to the lack of external incisions, the ROSE procedure is expected to provide important advantages, including less risk than traditional open or laparoscopic surgery, minimal postoperative pain, fast recovery time, and no scarring.
Keeping your weight down after gastric bypass is vital to improve your health and reduce the co-morbidities associated with obesity such as Type II diabetes, heart disease, joint disease, and respiratory conditions. If you have started to regain weight since your initial surgery, ask your surgeon if the ROSE procedure might be right for you.
Because of Dr. Balder's experience in performing the R.O.S.E. Procedure, he has been chosen as a proctor (teacher) for other surgeons by USGI Medical, Inc. to consult and educate the Bariatric Community in this NEW "incisionless" surgery.
FAQ
What is the ROSE PROCEDURE?
New surgical tools now allow specialty trained bariatric surgeons like Dr Balder to reduce the size of the pouch and stoma through the patient’s mouth without making external cuts into the body. We may refer to this as the acronym “ROSE” procedure, which stands for Restorative Obesity Surgery, Endoscopic.
Before the ROSE incisionless procedure, patients who regained weight after gastric bypass generally had few treatment options. Scarring and adhesions related to the initial bypass procedure make open or laparoscopic revision surgery very challenging. Revision surgery procedure time is typically longer than the original bypass procedure and patients can be up to three times more likely to develop a complications following revision surgery. Therefore, most patients who regain weight after gastric bypass opt not to undergo open or laparoscopic surgical revision after weighing the risks and benefits.
Why would I gain weight after gastric bypass?
A number of studies suggest that patients regain weight due to the gradual enlargement of the surgically altered small stomach pouch and stoma, (connection between the stomach and small intestine). When the Roux-en-Y procedure is performed, the stomach and stoma are made very small, which slows the passage of food and creates a feeling of fullness after just a small volume of food is eaten. It is believed that when the stomach pouch and stoma gradually enlarge, the feeling of fullness is no longer present, patients can eat larger meals, and weight regain occurs.
How do I find out if I’m eligible for this new incisionless, restorative ROSE procedure?
Patients who had a Roux-en-Y gastric bypass more than 2 years ago, lost over 50% of their excess weight and have now regained 15% or more of this weight are probably the most ideal candidates for this procedure. Other patients who may be candidates for the ROSE procedure include patients with gastro-gastric fistulas (associated with weight regain), poor weight loss following a primary procedure (especially if following program dietary and exercise guidelines), and others as well.
After an initial office visit with Dr Balder & review of your prior operative note and weight loss history patients will typically undergo a full medical history and physical examination followed by nutritional and dietary counseling (done in our office for patient convenience), and probably and upper endoscopy procedure to determine if you are a good candidate. (See last item below on how to "get started"!)
What does the ROSE procedure entail?
The ROSE procedure is performed using a small flexible endoscope and a new EndoSurgical Operating System (EOS). The scope and the EOS instruments are inserted through the mouth into the stomach pouch the same way as a standard endoscope. Tissue anchors are used to create multiple, circumferential tissue folds around the stoma to reduce the diameter, typically to about 10mm. The surgeon will then use the same technique to place anchors in the stomach pouch to reduce its volume capacity. After the procedure the patient will enter Advanced Surgical Associates standard bariatric surgery follow-up program of nutritional counseling and exercise, similar (hopefully) to the one prescribed after their original or previous gastric bypass surgery.
What instruments are used?
The ROSE procedure is performed with a new EndoSurgical Operating System (EOS) and a small flexible endoscope for visualization. The EOS consists of a long narrow access platform called the TransPort™ and specialized surgical tools (that grab tissue, hold it in place and insert anchors and sutures), all of which are cleared by the U.S. Food and Drug Administration (FDA). Dr Balder will easily advance the TransPort™ into the GI tract in its flexible state, guided by the camera and light in the endoscope that’s inserted into one of its four working channels. With a squeeze of the handle, the TransPort™ locks into place, conforming to the patient’s unique anatomy. Once locked in place, the surgeon can advance the different surgical tools through its remaining three channels and then steer the end of the device freely to visualize a site and operate with efficiency and precision. The TransPort™ allows the surgeon use both hands to manipulate and view tissue.
Where will the procedure be performed?
The ROSE procedure may be performed in a Hospital Operating Room, an Outpatient Surgery Center or an Endoscopy Suite. Generally at this point we'll plan to do most of these procedures for patient convenience at the Rivertown Out-Patient Surgery Center.
How long will I need to stay in the surgery center or hospital setting?
Typically, patients would be discharged home a few hours after the planned procedure. If a hospital stay is necessary, it would be typically planned as an "observation" setting or less than 23 hours (if severe associated illness such as underlying heart, lung, kidney or other disease is present).
What are the benefits of an incisionless procedure?
By eliminating skin incisions, this new procedure may provide important advantages to patients, including, reduced risk of infection and associated complications, less post-operative pain, faster recovery time, and no abdominal scars. Revision open Gastric surgery - especially revisional Bariatric surgery is fraught with high rates of complications, especially infections and bleeding problems. Avoiding this extensive scarred plane of tissues is of fantastic benefit if possible thru a "natural orifice technique" such as the ROSE procedure!
What type of side effects can I expect?
It is anticipated that patients will feel little or no discomfort from the procedure. To date, the only noted side effects have been short-term sore throat, swollen tongue and lip pain from the insertion of the instruments into the mouth.
Is it safe?
As with any surgery there are potential risks involved (As I tell my patients, "I know of no operative procedure done today that has zero risk"). This less invasive approach should dramatically reduce the likelihood of many of the complications associated with the open or laparoscopic revision surgery.
What is the success rate?
It is too soon to estimate the likely procedure success rate. However, to date, the procedure has been well tolerated and the first few patients have experienced weight loss within the first 4 weeks and a reduction in food volume capacity.
What is the recovery process?
Typically this is done in the opt-patient setting and our patients should plan to return to normal activity within a few days of their procedure. You will be given any specific restrictions and specific discharge instructions after your procedure. In addition, my patients will be asked to complete an educational module with regard to post-operative gastric bypass needs (which may have changed over the years from what they were previously told), and follow a post bariatric surgery diet and exercise plan, similar to the regimen prescribed by our office following the initial roux-en-y gastric bypass surgery. In addition, follow-up appointments with your Dr. Balder and regular visits with bariatric support staff (including support groups) will be required.
Will it be covered by insurance?
As with gastric bypass surgery or Lap Band surgery, coverage will vary depending upon the insurance provider. *Currently, there is no insurance code for this procedure. Our insurance specialist, Donna Tomlinson in our office can and will discuss your plan with you at your request. In the event insurance will not cover the procedure, financing options are available. We typically utilize Care Credit, but have other sites available as necessary. Advanced Surgical Associates has this information on possible financing programs as well as potential tax advantages for any health expenses you may incur. Unfortunately due to the insurance climate, we do not accept Medicare without secondary insurance (this does not include Medicaid) or any Medicaid insurance beginning January 1, 2010 for VNUS. We will not be accepting Medicare/Medicaid for Bariatrics; we will continue to care for our current patient population.
What will the procedure cost?
The cost for the procedure will vary depending upon where the procedure is performed, how long you stay in the facility and other factors. The cost of the R.O.S.E. Procedure is $9900.00 (no hidden costs!) and is currently done at our affiliated out-patient facility Rivertown Surgery Center. This includes all charges for the day of the procedure including the surgeons' fee, anesthesia fees, and the cost of the out-patient surgery procedure or facility charge). This fee does not cover evaluation to determine if you are a candidate. You will need to make an appointment to determine if you are a candidate which will be discussed during your consultation visit with Dr. Balder.
Is incisionless surgery just for Gastric Bypass restorations?
This procedure is one of the first of many potential applications for Incisionless Surgery. Incisionless Surgery is considered the next wave in minimally invasive procedures and, in addition to obesity; it has generated interest among physicians in areas such as GERD, GI cancer and NOTES (Natural Orifice Translumenal Endoscopic Surgery).
Have you regained some of the weight you initially lost after Gastric Bypass Surgery?
Your stomach pouch or stoma (the connection between the pouch and small intestine) may have stretched out in the years since your original surgery, reducing the feeling of fullness after you eat. We now offer the R.O.S.E. - Restorative Obesity Surgery Endoscopic, procedure, an incisionless surgical procedure that restores the size of the pouch and stoma close to the original post-surgery proportions. Using new surgical tools, surgeons create and suture folds into the pouch to reduce its volume and at the stoma to reduce its diameter. The surgeon performs the procedure entirely through the mouth without making any external incisions into the body. Due to the lack of external incisions, the R.O.S.E. - Restorative Obesity Surgery Endoscopic procedure is expected to provide important advantages, including, less risk than traditional open or laparoscopic surgery, minimal postoperative pain, fast recovery time and no scarring. Keeping your weight down after gastric bypass is vital to improve your health and reduce the co-morbidities associated with obesity such as Type II diabetes, heart disease, joint disease and respiratory conditions. If you have started to regain weight since your initial surgery, please contact us.
Who is eligible for the new incisionless, R.O.S.E. - Restorative Obesity Surgery Endoscopic procedure?
Patients who were originally successful losing weight following Gastric Bypass and now find themselves regaining weight may be ideal candidates for this procedure. After an initial screening, you will undergo a series of evaluations including nutritional and dietary counseling, a full medical exam and endoscopy to determine if you are a good candidate.
How long will I need to stay in the hospital?
The length of your stay will be determined by your surgeon. You may be discharged the same day if the procedure was done early in the morning, or your surgeon may want you to stay overnight. Your surgeon will make the determination following your procedure.
What are the benefits of an incisionless procedure?
By eliminating skin incisions, this new procedure may provide important advantages to patients, including reduced risk of infection and associated complications, less post-operative pain, faster recovery time, and no abdominal scars. Most optimally, it will allow gastric bypass patients who need help with an additional tool the opportunity to get back on track with weight loss and possibly reduction in their associated co-morbidities.
Dr Balder recently commented in a CBS news interview (with WBTW) here in Myrtle Beach "It will essentially, give a number of patients who have possibly failed their gastric bypass experience a second chance on their weight loss and just as importantly with their health!"
What type of side effects can I expect?
It is anticipated that patients will feel little or no discomfort from the procedure. The most common reported side effect has been short-term sore throat.
Is it safe?
As with any surgery there is risk involved. The ROSE - Restorative Obesity Surgery Endoscopic procedure is new and long-term data are not yet available. This less invasive approach should reduce the likelihood of many of the complications associated with the other open or laparoscopic revision procedures.
What is the success rate?
As with any weight loss procedure, results vary with each patient. The R.O.S.E. - Restorative Obesity Surgery Endoscopic procedure has been well tolerated and most patients experience weight loss as they eat less – with the return of the early feeling of “fullness” due to the restriction of the new, smaller pouch. The R.O.S.E. procedure is new and long term data are not yet available.
What is the next step if interested in the ROSE procedure?
Interested patients should obtain a copy of their prior gastric bypass operative note and schedule an appointment for a detailed evaluation with Dr. Balder. If there are problems obtaining an old operative note, please feel free to come by our office and sign a waiver to send to your prior surgeon or hospital - we can assist in this process for your total care! In order for Dr Balder to optimally treat and evaluate you, it is often very, very helpful to have your pre-operative & post-operative information from you previous Bariatric Surgeons office as well (and any post procedure notes such as upper endoscopy or barium upper GI study). Because of healthcare privacy laws we will require your personal hand-written signature in our office if you would like us to assist you with this. For your convenience this is optimally done several days to a week prior to your planned office appointment with Dr Balder. Offices and hospitals often take much more time to "release" these records than you would anticipate!
We eagerly look forward to assisting you with your weight loss journey! Happy health and weight loss!