Informed Consent Agreement

This Informed Consent Agreement ("Agreement") outlines the terms and conditions of the Gastric Balloon Insertion Services ("Services") offered by the Nairobi Bariatric Center ("Clinic"). By signing this Agreement, you are consenting to participate in the Services, and you agree to abide by the responsibilities and terms outlined below:

• Procedure Overview

As explained to me by the consulting doctor, I understand the anatomy of the gastric balloon procedure as follows:

1. A deflated gastric balloon will be inserted into the stomach endoscopically and then inflated with between 400-500mL of saline solution with a blue dye
2. The balloon occupies space in the stomach, creating a feeling of fullness and limiting food intake whereby one feels full with smaller amounts of food, thereby resulting in weight loss over approximately 6 months
3. The balloon must be removed after 6 months to avoid potential complications.

Procedure Consent

I consent to have a Laparoscopic Gastric Balloon for the purpose of medical weight loss. I had an initial consultation with Nairobi Bariatric Center’s doctor, Dr. Shchukina, and we have agreed that my treatment will be the Gastric Balloon Procedure combined with Weight Loss Psychotherapy for sustainable results.

I will meet my attending surgeon who will perform the procedure on the day of the procedure at the Nairobi Bariatric Center Endoscopic Unit. 

Benefits of the Gastric Balloon

It was brought to my attention that obesity is associated with early death and significant medical problems such as diabetes, obstructive sleep apnea, high cholesterol, infertility, cancer, gastro-esophageal reflux, arthritis, chronic headaches, gout, venous stasis disease, liver disease and heart failure, among other problems. This procedure aims to help you lose weight and improve the aforementioned obesity-related conditions.

Side Effects and Risks of the Gastric Balloon

I understand that there might be some common initial side effects associated with the procedure commonly experienced within the first few days after the procedure, such as:

1. Nausea, vomiting, cramping, heartburn and constipation 
2. Acidity
3. Hypersalivation or dryness of the mouth

I understand that risks associated with the Gastric Balloon are very low but may include:

1. Ulcers or balloon deflation/leakage (less than 1% risk)
   1. Bursting and/or leakage of the balloon is highly associated with keeping the balloon in the body beyond 6 months. The balloon may then pass from the stomach into the small bowel/intestine and cause bowel obstruction. If this occurs, surgery or endoscopic removal could be required. 

1. Bowel obstruction if balloon deflates and passes into intestine (requires surgery)
2. Death: Less than 1 in 2000 risk

Post Gastric Balloon Aftercare Expectations

I understand that it is required to undergo three (3) days of administration of IV fluids, and some IV medications to mitigate side effects. 

I was informed on how I will need to eat and drink for the balloon to settle well, smoothly and to get the best result in my weight loss journey.

I was informed to keep a check on my urine for color change to blue after gastric balloon insertion and to inform the Bariatric Nurse immediately should it happen. If it is still blue, the balloon will be removed and replaced as it has leaked and may cause further complications.

I understand that the balloon MUST be removed at 6 months after insertion to avoid any complications that may occur due to overstay with the balloon.

In summary of Aftercare Expectations:

1. Be present for the 3 days IV fluid support at the clinic
2. Follow all post-procedure instructions closely
3. Attend all follow-up appointments as scheduled
4. Have the balloon removed after 6 months
5. Monitor urine for any colour change
6. Notify our bariatric team of any concerning symptoms

Alternative Options

Alternatives may include diet programs, exercise plans, weight loss medications, psychotherapy, and bariatric surgery. These options may be discussed to identify whether they may be appropriate for you.

Patient Responsibilities

In order to achieve your weight loss goals, it is important to be compliant and accept specific responsibilities, such as:

1. I understand that if I do not follow through with all the terms of this document my physician may refuse to perform the procedure or may discharge me as a patient from the practice at any time.
2. I will fully communicate to my physician any concerns and will also communicate to my physician or other applicable healthcare provider any suspected complications after Gastric Balloon insertion.
3. I agree to keep my follow up appointments as recommended by my surgeon and/ or primary care physician.
4. I agree to see my surgeon and family physician as directed.
5. Any medical condition that exists or may develop, not in direct relationship to the gastric balloon insertion, must be treated by my primary care physician (and/or appropriate specialty physician), and I agree to coordinate my care with my surgeon. I understand that my surgeon may not be able to treat me or fill prescriptions for other medical conditions.
6. I understand that successful long-term weight loss is dependent on following the principles and guidelines of the bariatric program.
7. I understand that Nairobi Bariatric Center will not be held legally liable for noncompliance and complications that occur from it and I shall take full responsibility. 

Financial Responsibility

I acknowledge that the payment of the procedure is non-refundable. I acknowledge that the cost of the gastric balloon insertion is exclusive of the cost of removal, supplementary IV fluids that extend beyond the first 3 days, and potential ultrasound or any other supplementary procedures that may be recommended by the center. 

Balloon Removal

I acknowledge that the removal cost of Ksh. 45,000 is excluded from the insertion cost and will be paid upon removal

Testimonial

Your journey can inspire many others considering weight loss procedures. Would you be open to sharing your story, photos, or even a video? You can choose to remain anonymous if you prefer. We'll always honor and present your experience with utmost respect. Your care and trust remain our priority.

Agreement

By signing below, I acknowledge that I have fully read and understood this informed consent form. I had the opportunity to ask questions and have them answered. I voluntarily consent to this gastric balloon procedure as described herein.