Informed Consent for Robotic-Assisted Laparoscopic Prostatectomy (RALP)

Procedure Name

Form Sections

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Surgical Facility Name

Attending Urologic Surgeon

Patient Full Legal Name

Date of Birth

MRN / Patient ID

Planned Nerve Sparing Approach

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Patient / LAR Signature

Surgeon Signature

Witness Signature

Date and Time of Consent

Informed Consent for Robotic-Assisted Laparoscopic Prostatectomy (RALP)

Patient and Surgical Information

Surgical Facility Name

Attending Urologic Surgeon

Patient Full Legal Name

Date of Birth

MRN / Patient ID

Planned Nerve Sparing Approach

Nature and Purpose of the Procedure

Robotic-assisted laparoscopic prostatectomy (RALP) is a surgical procedure performed under general anesthesia to remove the entire prostate gland, seminal vesicles, and surrounding tissue to treat localized prostate cancer. The surgeon makes several small abdominal incisions and inserts laparoscopic instruments connected to a robotic surgical console. The surgeon controls the robotic arms, which provide a high-definition 3D view and extreme instrument dexterity. Depending on the stage and location of the cancer, the surgeon may perform a bilateral or unilateral nerve-sparing technique to preserve the delicate cavernous nerves responsible for erections. Pelvic lymph nodes may also be removed (pelvic lymph node dissection) to check for cancer spread. After the prostate is removed, the urinary bladder is re-attached to the urethra (urethrovesical anastomosis) over a temporary urinary catheter, which remains in place for 7 to 14 days. The surgery typically takes 2 to 4 hours.

Authorization for Open Conversion

While the surgery is planned laparoscopically with robotic assistance, unpredictable circumstances can arise. These include dense anatomical scar tissue, extensive bleeding, technical equipment failure, or unexpected extension of the tumor. In such cases, the surgeon must be authorized to immediately convert the procedure to a traditional open radical prostatectomy through a larger lower abdominal incision to ensure patient safety and complete tumor removal.

Material Risks and Potential Complications

Erectile dysfunction: damage or stretching of the cavernous nerves during surgery can cause temporary or permanent impotence. With bilateral nerve-sparing, erectile recovery rates range from 50 to 80 percent within 12 to 24 months, often requiring oral medications or vacuum devices. For non-nerve-sparing procedures, permanent erectile dysfunction is expected.

Urinary incontinence: temporary leakage of urine is extremely common after catheter removal. Most patients recover urinary control within 3 to 6 months, but up to 5 to 10 percent of patients may experience mild permanent stress incontinence requiring pads, and 1 to 2 percent may require secondary surgery (such as a male sling or artificial urinary sphincter).

Positive surgical margins: cancer cells may be found at the outer edge of the removed tissue, indicating some microscopic cancer may remain. This occurs in 10 to 30 percent of cases, depending on tumor stage, and may require secondary treatments such as radiation therapy or hormone therapy.

Bladder neck contracture: scarring at the connection between the bladder and urethra, occurring in 1 to 3 percent of cases, which can cause urinary stream narrowing and may require a minor endoscopic procedure to open the scar tissue.

Injury to surrounding organs: inadvertent damage to the rectum (less than 1 percent), ureters, or major blood vessels, which may require immediate surgical repair during the procedure.

Lymphocele or deep vein thrombosis (DVT): accumulation of lymphatic fluid in the pelvis or blood clots in the legs or lungs, which are minimized with compression devices and early mobilization.

Expected Benefits

The primary expected benefit of a robotic prostatectomy is a definitive surgical cure or long-term local control of localized prostate cancer. Pathological examination of the removed prostate also provides precise tumor staging and grading, which is essential for determining if any further cancer therapies are necessary.

Reasonable Alternatives to Surgery

Active surveillance: closely monitoring low-risk prostate cancer with regular PSA tests, digital rectal exams, and repeat biopsies, delaying treatment until the tumor shows signs of progression.

Radiation therapy: external beam radiation therapy (EBRT) or radioactive seed implants (brachytherapy), which achieve similar cancer control rates for localized tumors but carry different risk profiles (such as delayed bowel and bladder side effects).

Hormone therapy (Androgen Deprivation Therapy): used to slow cancer growth, typically reserved for advanced or metastatic disease, or combined with radiation.

Observation / Decline treatment: choosing no intervention, accepting the risk of progressive cancer growth and distant metastasis.

Right to Refuse or Withdraw Consent

You have the right to refuse this procedure or withdraw your consent at any time before the surgery begins without penalty or adverse effect on your medical care. Your urologist will discuss other cancer management options with you if you choose not to proceed.

Questions and Understanding Confirmation

I confirm that I have reviewed this consent form with my urologist. I understand the expected recovery timeline for bladder control, the risk of erectile dysfunction depending on the nerve-sparing technique, the risk of a positive margin, and I authorize conversion to open surgery if required. All my questions have been answered.

Language Access and Interpreter Services

If English is not your primary language or if you require assistance communicating, a qualified medical interpreter is available to you at no cost. Please notify your care team if you require interpreter services before signing this document.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this informed consent form for my own records. I understand I may request an additional copy at any time from the facility or clinical records department.

Patient Authorization

I have been informed of the robotic-assisted radical prostatectomy procedure, its expected benefits, the material risks listed above, and available alternatives. I consent to proceed with a robotic prostatectomy and authorize the surgeon and surgical team to convert to an open radical prostatectomy if deemed necessary for patient safety.

Signatures and Verification

Patient / LAR Signature

Surgeon Signature

Witness Signature

Date and Time of Consent

Document ID: CC-PENDING

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