Informed Consent Agreement

This Informed Consent Agreement ("Agreement") outlines the terms and conditions of the Gastric Bypass Surgery ("Services") offered by the Nairobi Bariatric Center Limited ("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

I consent to have Gastric Bypass surgery for the purpose of medical weight loss. I had an initial consultation with Nairobi Bariatric Center’s bariatric surgery team Dr. Shchukina before the procedure, and the rest of the surgery group on the day of the procedure at the Nairobi South Hospital.

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

The stomach is divided into a small “pouch” in which food enters, and one large “remnant stomach” through which the food no longer passes. This “excluded” part of the stomach remains in the body and continues to produce helpful digestive juices, which meet the food further downstream. 

The upper, smaller “pouch” holds a smaller amount of food than before, and is connected directly to a portion of the small intestine, bypassing the larger part of the stomach created by the procedure. Creating a smaller stomach pouch limits the amount of food that one can eat, so the person feels full sooner and stays full for longer. Additionally, bypassing a part of the intestine limits calorie absorption, allowing vitamins and nutrients to be fully absorbed.

Side effects

I understand that in addition to the risks involved, I may experience various side effects and symptoms following bariatric surgery. These may include, but not be limited to:

Short-term side effects:

• Pain or discomfort at the incision sites
• Fatigue and weakness as the body recovers
• Body aches and headaches
• Anemia
• Swelling around incisions
• Nausea and vomiting
• Constipation
• Abdominal cramping
• Ulcers
• Low blood sugar
• Dehydration

Longer-term side effects:

• Nutrition-related issues like vitamin deficiencies, malnutrition, hypoglycemia
• Gastrointestinal issues like acid reflux, bloating, abdominal pain, diarrhea
• Gallstones
• Depression or mood changes
• Relationship issues due to lifestyle changes
• Excess skin needing surgical removal
• Strictures or hernias requiring additional surgery
• Hair thinning and loss
• Ketosis from rapid weight loss
• Development of eating disorders or transfer addictions

I understand that I must follow all post-operative instructions carefully, attend follow-ups, take supplements as directed, and report concerning symptoms to prevent or minimize risks and side effects. This surgery is not risk-free and complications or suboptimal results may occur even with proper surgical technique. 

Risks

I understand this surgery has potential risks and complications, which have been explained to me by the surgical team. These include but are not limited to:

• Infection at the incision site or internally
• Blood clots that can travel to the lungs
• Bleeding during or after surgery
• Adverse reactions to anesthesia
• Injury to organs surrounding the stomach and intestines
• Leaks from staple lines or suture sites
• Bowel obstruction due to internal scarring
• Gallstones
• Ulcers
• Nutritional deficiencies if dietary guidelines not followed
• Excess skin needing removal
• Hernias
• Deep vein thrombosis
• Lung complications such as pneumonia
• Need for revision surgery
• Death (less than 1% risk)

Additional Procedures

By agreeing to the gastric bypass procedure, I understand that unforeseen conditions may necessitate extension of the original procedure. I therefore authorize and request that the Surgeon and the bariatric surgery team perform such procedure(s) as may be necessary and desirable in the exercise of their professional judgment. In the unlikely event that one or more complications may occur, the bariatric surgery team will take appropriate and reasonable steps to help manage the clinical situation and be available to me and my family to address any concerns and questions.

Optional Insurance

I acknowledge that I was given the option of paying a non-refundable insurance fee of 

KES. 29,000 should there be any additional procedures performed due to complications from the surgery itself. This fee would cover any additional costs that are related only to potential surgery complications, including an extended hospital admission, surgeon fees, anesthesiologist fees, medications, etc. 

I understand that should I opt not to get this insurance, I will be responsible for the full cost of any additional procedures as prescribed in the previous clause. I hereby consent to the procedure as described.

Patient Responsibilities

• 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.
• 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 surgery.  
• I agree to comply with the pre- and post-surgery protocols, which includes attending support group programs, following the diet(s) provided to me, and behavior modification.
• I agree to keep my follow up appointments as recommended by my surgeon and/or primary care physician. 
• I agree to take my vitamins, calcium and other supplements for life as directed by my surgeon and/or primary care physician.
• I agree to have blood work done for life on an at least annual basis. 
• I agree to see my surgeon and family physician as directed.
• Any medical condition that exists or may develop, not in direct relationship to the bariatric surgery, 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.
• I understand that successful long-term weight loss is dependent on following the principles and guidelines of my surgeon’s bariatric program.

Protein and Vitamin Supplement Policy

• I understand the Gastric Bypass is both malabsorptive and restrictive; if I do not take the recommended vitamin/mineral supplements, I may develop vitamin/mineral deficiencies.
• I understand that my bariatric surgery team may ask me to keep a food journal/diary to help assess nutritional problems, protein/vitamin intake or disordered eating behavior.
• I can expect nutritional lab work to be done at least annually for the rest of my life. It is my responsibility to complete my lab orders as directed.
• I understand the importance of a balanced diet including protein which promotes satiety (fullness) and protects muscle mass during active weight loss.
• I agree to take the recommended vitamin/mineral supplementation regimen recommended by my bariatric surgery team which typically includes multivitamin, vitamin B12, calcium citrate, vitamin D, (and others as indicated by deficiencies found in my lab work).
• I agree to continue these new eating habits and behaviors I learned prior surgery to optimize my weight loss and nutrition. I will continue to choose these new healthier eating habits for life.
• If my lab work shows vitamin/mineral deficiencies before surgery, I may need to repeat these levels before having surgery to optimize my health.
• It is my responsibility to ask questions when I am uncertain about vitamins and protein supplements.
• I understand that if I fail to accept my responsibility for care as directed by my bariatric surgery team, I could be terminated from their care.

Smoking and Alcohol Policies

Smoking:

I understand that smoking significantly increases surgical risks and complications. To minimize these dangers, I agree to:

• Stop smoking at least 8 weeks prior to surgery as recommended
• Undergo smoking cessation counseling if needed
• Avoid secondhand smoke exposure before surgery
• Inform my surgical team if I am unable to quit smoking prior to surgery
• Stay smoke-free for at least 8 weeks following surgery for optimal healing

I understand risks are higher for current smokers, including:

• Increased rate of infection, blood clots, and pneumonia
• Impaired wound healing and lung function
• Higher risk of heart and lung complications
• Greater likelihood of requiring intensive medical care

Alcohol Use:

I understand that alcohol metabolism is altered following bariatric surgery. 

To minimize risks, I agree to:

• Abstain from any alcohol consumption for at least 2 months post-operatively
• Abstain from binge drinking episodes indefinitely after surgery
• Limit intake to no more than 1-2 drinks per week once my surgical team deems it safe
• Avoid drinking within 2 hours of a meal to prevent rapid intoxication
• Discuss any worrisome drinking behaviors with my bariatric team

I understand excess alcohol post-surgery may contribute to:

• Alcohol dependency and abuse tendencies
• Severe intoxication episodes
• Greatest impaired metabolism leading to accidents or poor decision making
• Interference with post-surgical nutrition, hydration, and healing

Payment Terms

I understand that my bariatric surgery will cost approximately KSH 850,000, with the following payment requirements:

• Acceptable payment methods include RTGS, cash or check.
• The Option Insurance covers complications immediately following surgery that may require revisional surgery, but does not cover for any complications that occur after these first few days that may necessitate IV fluids or any other support
• The total fees cover the surgeon, anesthesiologist, operating room fees, equipment, and standard post-operative care. Unless the Optional Insurance is bought, these fees do not include additional nights in the hospital, complications management, or revisions.
• Unless I have bought the Optional Insurance, if I undergo a revision or additional procedure related to the original surgery, further fees will apply which I am responsible for.
• I agree not to schedule the surgery date until payment requirements are clearly understood and accepted.

By signing this form, I acknowledge and accept complete responsibility for all quoted and unquoted financial obligations related to the surgery. I have had the opportunity to discuss costs and disclose my payment abilities prior to scheduling.

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Agreement and Signature

I have read this entire informed consent form carefully and understand all of the information contained herein. My bariatric surgeon has explained the risks, benefits, alternatives, and expected results of the gastric bypass surgery procedure.

I have had the opportunity to ask any questions I may have and to discuss concerns openly. My questions and concerns have been addressed to my satisfaction by my surgical team.

I understand that bariatric surgery is not without risks and complications can occur. I have been informed of the potential risks, side effects, lifestyle changes, and other expectations that come with having bariatric surgery.

I agree to adhere strictly to all pre-operative and post-operative instructions provided to me for optimum results and safety. I understand this informed consent is not meant to scare or deter me from proceeding with the recommended procedure. It is intended to properly inform me so I may make a fully educated decision.

I enter into this procedure voluntarily. I hereby authorize and consent to undergoing the gastric bypass surgery as described herein.