Vaginal Hysterectomy with Laparoscopic Assistance


	UM Guidelines

Inpatient and Surgical Care (ISC) ORG: S-665

BCBST modification effective November 30, 2007*

Deleted from: Clinical Indications

Milliman Care Guidelines Clinical Indications were deleted.

Added to: Clinical Indications

Definitions for Hysterectomy Criteria

Abnormal Uterine bleeding: profuse bleeding or repetitive periods lasting > 8 days.

Conservative Treatment: May include but is not limited to:

Non-steroidal anti-inflammatory therapy (NSAIDS)

Laparoscopic procedure

Cyclical hormonal therapy

Suppressive hormonal therapy

Uterine artery embolization (UAE)

D&C

Hysteroscopy

Endometrial ablation or resection

Myomectomy

LEEP, etc.

Pain:

Mild = Intermittent, not interfering with ability to work, analgesics required but not chronically.

Moderate = Continuous, not interfering with work, requires chronic analgesic, such as NSAIDS, for > 3 months.

Severe = Continuous, causing absence from work, > 3 months of NSAIDS have failed & narcotics required for pain relief.

Postmenopausal: Cessation of menstruation for > 12 months.

Suppressive Hormonal Therapy: Hormonal therapy of sufficient potency to inhibit ovulation in a pre or peri-menopausal female. Such therapies include a combination of an estrogen and progestin (as in combination oral contraceptive pills), progestin only suppression (as in a "mini-pill" or depo-medroxyprogesterone) or GnRH agonist. A smoker > age 35 does not represent a contra-indication to progestin only or GnRH agonist suppressive therapy.

Uterine Size is described in terms of gestational weeks determined by physical exam.

Hysterectomy remains one of the most debated surgical procedures. Probably 80% of hysterectomies are discretionary in that there is at least one reasonable alternative. This may include observation, hormonal therapy, NSAID's, GnRH inhibitors, conservative procedures including endometrial ablation and myomectomy. Informed collaboration with documented active participation of patient in decision-making is appropriate.

The appropriate route of hysterectomy, abdominal, vaginal or laparoscopic (LAVH) depends on the patient's anatomy and pathology and the surgeon's experience and skills. The decision-making process can be expected to vary within communities, institutions, and surgeons. In general, LAVH is used for a very low percentage of hysterectomies.

Hysterectomy for sterilization is not indicated.

Surgery should meet at least one indication clearly.

I. Emergencies

Women with any of the following:

Postpartum complications

Extensive uterine infection with sepsis

Operative complications

Ruptured Uterus

II. Malignancy

Women with any of the following:

Ovarian

Uterine

Invasive carcinoma

Microinvasive carcinoma

Endometrial adeno-carcinoma in situ

Trophoblastic disease unresponsive to chemotherapy

Cervical

Invasive carcinoma, biopsy diagnosed

Microinvasive carcinoma, biopsy diagnosed

Adenocarcinoma (any stage), biopsy diagnosed

III. Premalignant Conditions

Women with one of the following:

Cervical Dysplasia (CIN III or greater)

Recurrent CIN III on repeat-cone biopsy (within 2 years of first conization)

Endometrial Hyperplasia

Atypical Adenomatous Hyperplasia in women with the following:

Endometrial biopsy within past 6 months which confirms atypical adenomatous hyperplasia; or

Any woman over 35 years of age, not wishing to have additional children, with adenomatous atypia confirmed by sampling

Adenomatous Hyperplasia without Atypia

Nonmetastatic gestational trophoblastic disease in a woman not desiring further fertility.

Note: Endometrial hyperplasia in absence of atypia, with resultant abnormal bleeding is rarely an indication for hysterectomy, since this condition can be managed medically in most cases. (ACOG 1989)

IV. Prophylactic Hysterectomy

Prophylactic hysterectomy for individuals receiving estrogen receptor antagonist for the treatment of breast cancer is not indicated.

Prophylactic oophorectomy / hysterectomy, for an individual with a high risk of hereditary ovarian cancer, is considered medically appropriate when one or more of the following high risk criteria are met:

Two or more first-degree relatives with ovarian or breast cancer; or

One first-degree relative and one second-degree with ovarian or breast cancer before the age of 50 years; or

One first-degree relative and two or more second-degree or third-degree relatives with ovarian or breast cancer; or

Presence of BRCA1 or BRCA2 mutation.

V. Uterine Leiomyoma

12 week gestational size by pelvic exam or ultrasound, a single myoma > 8 cm documented size by ultrasound or documented growth of a single myoma > 2 cm/year by ultrasound; or

Palpable myomatous enlargement that is symptomatic

For criteria regarding symptoms see other sections of this tool, i.e. Abnormal Uterine Bleeding, Pain, etc.

VI. Endometriosis

Confirmation of endometriosis by biopsy or direct visualization, or a positive therapeutic response to a 3-month trial with a gonadotropin-releasing hormone (GnRH) agonist analog (e.g., Lupron Depot® or Leuprolide acetate for depot suspension) and one of the following:

Documented failure of conservative treatment (3 consecutive months of suppressive hormonal therapy) or procedure, or

Significant involvement of other organ systems, affecting normal physiologic function

VII. Abnormal Uterine Bleeding

Postmenopausal Women with all of the following:

Moderate to severe bleeding where all other common causes for uterine bleeding, including endometrial cancer, have been excluded

Bleeding persists after 3-month trial of hormonal treatment (unless both estrogen and progesterone hormonal treatments contraindicated)

Correctable pathology, such as submucosal fibroids, endometrial polyp, or other conditions, ruled out by an endometrial stripe < 5mm on vaginal probe ultrasound or one of either hysteroscopy or hysterosonogram, within the past 12 months

The bleeding is not iatrogenic due to HRT

Peri- or Premenopausal Women with all of the following:

Patient continues to have severe uterine bleeding as demonstrated by one or more of the following:

Repetitive periods lasting > 8 days; and/or

Anemia (Hct <30) due to blood loss; and/or

An inter-menstrual interval consistently less than 20 days; and/or

Menses of normal duration with extraordinary blood loss

All other common causes for uterine bleeding such as endometrial cancer and iatrogenic have been excluded

Bleeding persists after 3-month trial of suppressive hormonal therapy (unless both estrogen and progesterone hormonal treatments contraindicated)

Correctable pathology, such as submucosal fibroids, endometrial polyp, or other conditions, ruled out by an endometrial stripe < 5mm on vaginal probe ultrasound or one of either hysteroscopy or hysterosonogram, within the past 12 months

VIII. Chronic Pelvic Pain or Dyspareunia

Women with all of the following:

> 6 consecutive months of moderate to severe pain

Unresponsive to conservative treatment including non-narcotic analgesics and hormonal suppressive therapy

Pathologic &/or other sources (GI, GU, Psychological) of pelvic pain ruled out

Laparoscopy within the past 2 years to exclude pathologic causes

IX. Pelvic Inflammatory Disease

Women with all of the following:

Documented persistent or recurrent infection

Failure of appropriate parenteral antibiotic therapy

X. Uterine Prolapse

Removal of a normal, well-supported uterus is not shown to improve the cure rate for operations designed to correct stress incontinence. Hysterectomy should be reserved for gynecologic indications alone. (ACOG 1995)

Uterine cervix at or below the introitus (hymenal ring) during standing or valsalva (not with examiner's traction); or

Uterine cervix at or below the ischial spines during standing or valsalva (not with examiner's traction) with the need for rectocele & / or cystocele repair

XI. Adenomyosis

Adenomyosis is a histological diagnosis which cannot be made by exam or imaging. Certain persistent symptoms, despite conservative therapy, may suggest adenomyosis as a diagnosis of exclusion. Criteria for these symptoms are as noted above for:

Bleeding (See VII)

Pain (See VIII)

Sources

BlueCross BlueShield of Tennessee network physicians. July - September 2006.

Church, J., & Simmang, C. (2003). Practice parameters for the treatment of patients with dominantly inherited colorectal cancer (familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer). Disease of the Colon and Rectum, 46 (8). 1001-1012.

PDR entry for depo-lupron. (2000). ACOG Technical Bulletin (14).

PDR entry for depo-provera. (2000). ACOG Technical Bulletin (18).

National Cancer Institute. (2005, February). Ovarian cancer (PDQ®): Prevention. Retrieved June 22, 2005 from http://www.nci.nih.gov/cancertopics/pdq/prevention/ovarian/healthprofessional/allpages/print.

National Cancer Institute. (2005, February). Ovarian epithelial cancer (PDQ®): Treatment. Retrieved June 22, 2005 from http://www.nci.nih.gov/cancertopics/pdq/treatment/ovarianepithelial/healthprofessional/allpages/print.

National Cancer Institute. (2004, November). Ovarian germ cell tumors (PDQ®): Treatment. Retrieved June 22, 2005 from http://www.nci.nih.gov/cancertopics/pdq/treatment/ovarian-germ-cell/healthprofessional/allpages/print.

The American College of Obstetricians and Gynecologist. (2000). Quality improvement in women's health.

U. S. Food and Drug Administration. (2005). Center for Devices and Radiological Health. Product label for Nolvadex (tamoxifen citrate). Retrieved June 15, 2005 from http://www.fda.gov/medwatch/SAFETY/2005/Mar_PI/Nolvadex_PI.pdf.

* These guideline(s) have been revised from the Milliman USA Milliman Care Guidelines. The portions of the guideline(s) which have been revised are identified through the use of [insert: italic, boldface, underlined, etc. as appropriate] text, and Milliman USA has neither reviewed nor approved the modified material. Any statement to the contrary or association of the modified material with Milliman USA is strictly prohibited. This document has been classified as public information.

The above information only contains the modified portion of the Milliman Care Guideline. If you wish to view the complete Milliman Care Guideline, please contact Milliman USA.

	Deleted from: Clinical Indications


	Milliman Care Guidelines Clinical Indications were deleted.

	Added to: Clinical Indications


	Definitions for Hysterectomy Criteria Abnormal Uterine bleeding: profuse bleeding or repetitive periods lasting > 8 days. Conservative Treatment: May include but is not limited to: Non-steroidal anti-inflammatory therapy (NSAIDS) Laparoscopic procedure Cyclical hormonal therapy Suppressive hormonal therapy Uterine artery embolization (UAE) D&C Hysteroscopy Endometrial ablation or resection Myomectomy LEEP, etc. Pain: Mild = Intermittent, not interfering with ability to work, analgesics required but not chronically. Moderate = Continuous, not interfering with work, requires chronic analgesic, such as NSAIDS, for > 3 months. Severe = Continuous, causing absence from work, > 3 months of NSAIDS have failed & narcotics required for pain relief. Postmenopausal: Cessation of menstruation for > 12 months. Suppressive Hormonal Therapy: Hormonal therapy of sufficient potency to inhibit ovulation in a pre or peri-menopausal female. Such therapies include a combination of an estrogen and progestin (as in combination oral contraceptive pills), progestin only suppression (as in a "mini-pill" or depo-medroxyprogesterone) or GnRH agonist. A smoker > age 35 does not represent a contra-indication to progestin only or GnRH agonist suppressive therapy. Uterine Size is described in terms of gestational weeks determined by physical exam. Hysterectomy remains one of the most debated surgical procedures. Probably 80% of hysterectomies are discretionary in that there is at least one reasonable alternative. This may include observation, hormonal therapy, NSAID's, GnRH inhibitors, conservative procedures including endometrial ablation and myomectomy. Informed collaboration with documented active participation of patient in decision-making is appropriate. The appropriate route of hysterectomy, abdominal, vaginal or laparoscopic (LAVH) depends on the patient's anatomy and pathology and the surgeon's experience and skills. The decision-making process can be expected to vary within communities, institutions, and surgeons. In general, LAVH is used for a very low percentage of hysterectomies. Hysterectomy for sterilization is not indicated. Surgery should meet at least *one* indication clearly. I. Emergencies Women with any of the following: Postpartum complications Extensive uterine infection with sepsis Operative complications Ruptured Uterus II. Malignancy Women with any of the following: Ovarian Uterine Invasive carcinoma Microinvasive carcinoma Endometrial adeno-carcinoma in situ Trophoblastic disease unresponsive to chemotherapy Cervical Invasive carcinoma, biopsy diagnosed Microinvasive carcinoma, biopsy diagnosed Adenocarcinoma (any stage), biopsy diagnosed III. Premalignant Conditions Women with one of the following: Cervical Dysplasia (CIN III or greater) Recurrent CIN III on repeat-cone biopsy (within 2 years of first conization) Endometrial Hyperplasia Atypical Adenomatous Hyperplasia in women with the following: Endometrial biopsy within past 6 months which confirms atypical adenomatous hyperplasia; or Any woman over 35 years of age, not wishing to have additional children, with adenomatous atypia confirmed by sampling Adenomatous Hyperplasia without Atypia Nonmetastatic gestational trophoblastic disease in a woman not desiring further fertility. Note: Endometrial hyperplasia in absence of atypia, with resultant abnormal bleeding is rarely an indication for hysterectomy, since this condition can be managed medically in most cases. (ACOG 1989) IV. Prophylactic Hysterectomy Prophylactic hysterectomy for individuals receiving estrogen receptor antagonist for the treatment of breast cancer is not* indicated.* Prophylactic oophorectomy / hysterectomy, for an individual with a high risk of hereditary ovarian cancer, is considered medically appropriate when one or more of the following high risk criteria are met: Two or more first-degree relatives with ovarian or breast cancer; or One first-degree relative and one second-degree with ovarian or breast cancer before the age of 50 years; or One first-degree relative and two or more second-degree or third-degree relatives with ovarian or breast cancer; or Presence of BRCA1 or BRCA2 mutation. V. Uterine Leiomyoma 12 week gestational size by pelvic exam or ultrasound, a single myoma > 8 cm documented size by ultrasound or documented growth of a single myoma > 2 cm/year by ultrasound; or Palpable myomatous enlargement that is symptomatic For criteria regarding symptoms see other sections of this tool, i.e. Abnormal Uterine Bleeding, Pain, etc. VI. Endometriosis Confirmation of endometriosis by biopsy or direct visualization, or a positive therapeutic response to a 3-month trial with a gonadotropin-releasing hormone (GnRH) agonist analog (e.g., Lupron Depot® or Leuprolide acetate for depot suspension) and one of the following: Documented failure of conservative treatment (3 consecutive months of suppressive hormonal therapy) or procedure, or Significant involvement of other organ systems, affecting normal physiologic function VII. Abnormal Uterine Bleeding Postmenopausal Women with all of the following: Moderate to severe bleeding where all other common causes for uterine bleeding, including endometrial cancer, have been excluded Bleeding persists after 3-month trial of hormonal treatment (unless both estrogen and progesterone hormonal treatments contraindicated) Correctable pathology, such as submucosal fibroids, endometrial polyp, or other conditions, ruled out by an endometrial stripe < 5mm on vaginal probe ultrasound or one of either hysteroscopy or hysterosonogram, within the past 12 months The bleeding is not iatrogenic due to HRT Peri- or Premenopausal Women with all of the following: Patient continues to have severe uterine bleeding as demonstrated by one or more of the following: Repetitive periods lasting > 8 days; and/or Anemia (Hct <30) due to blood loss; and/or An inter-menstrual interval consistently less than 20 days; and/or Menses of normal duration with extraordinary blood loss All other common causes for uterine bleeding such as endometrial cancer and iatrogenic have been excluded Bleeding persists after 3-month trial of suppressive hormonal therapy (unless both estrogen and progesterone hormonal treatments contraindicated) Correctable pathology, such as submucosal fibroids, endometrial polyp, or other conditions, ruled out by an endometrial stripe < 5mm on vaginal probe ultrasound or one of either hysteroscopy or hysterosonogram, within the past 12 months VIII. Chronic Pelvic Pain or Dyspareunia Women with all of the following: > 6 consecutive months of moderate to severe pain Unresponsive to conservative treatment including non-narcotic analgesics and hormonal suppressive therapy Pathologic &/or other sources (GI, GU, Psychological) of pelvic pain ruled out Laparoscopy within the past 2 years to exclude pathologic causes IX. Pelvic Inflammatory Disease Women with all of the following: Documented persistent or recurrent infection Failure of appropriate parenteral antibiotic therapy X. Uterine Prolapse Removal of a normal, well-supported uterus is not shown to improve the cure rate for operations designed to correct stress incontinence. Hysterectomy should be reserved for gynecologic indications alone. (ACOG 1995) Uterine cervix at or below the introitus (hymenal ring) during standing or valsalva (not with examiner's traction); or Uterine cervix at or below the ischial spines during standing or valsalva (not with examiner's traction) with the need for rectocele & / or cystocele repair XI. Adenomyosis Adenomyosis is a histological diagnosis which cannot be made by exam or imaging. Certain persistent symptoms, despite conservative therapy, may suggest adenomyosis as a diagnosis of exclusion. Criteria for these symptoms are as noted above for: Bleeding (See VII) Pain (See VIII) Sources BlueCross BlueShield of Tennessee network physicians. July - September 2006. Church, J., & Simmang, C. (2003). Practice parameters for the treatment of patients with dominantly inherited colorectal cancer (familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer). Disease of the Colon and Rectum, 46 (8). 1001-1012. PDR entry for depo-lupron. (2000). ACOG Technical Bulletin (14). PDR entry for depo-provera. (2000). ACOG Technical Bulletin (18). National Cancer Institute. (2005, February). Ovarian cancer (PDQ®): Prevention. Retrieved June 22, 2005 from http://www.nci.nih.gov/cancertopics/pdq/prevention/ovarian/healthprofessional/allpages/print. National Cancer Institute. (2005, February). Ovarian epithelial cancer (PDQ®): Treatment. Retrieved June 22, 2005 from http://www.nci.nih.gov/cancertopics/pdq/treatment/ovarianepithelial/healthprofessional/allpages/print. National Cancer Institute. (2004, November). Ovarian germ cell tumors (PDQ®): Treatment. Retrieved June 22, 2005 from http://www.nci.nih.gov/cancertopics/pdq/treatment/ovarian-germ-cell/healthprofessional/allpages/print. The American College of Obstetricians and Gynecologist. (2000). Quality improvement in women's health. U. S. Food and Drug Administration. (2005). Center for Devices and Radiological Health. Product label for Nolvadex (tamoxifen citrate). Retrieved June 15, 2005 from http://www.fda.gov/medwatch/SAFETY/2005/Mar_PI/Nolvadex_PI.pdf.