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A
Randomized Trial of Intrastromal Abdominal Hysterectomy
To Support Shorter Hospital Stays and Prevent Blood Loss
Without Disturbing the Pelvic Support.
OBJECTIVE:
To evaluate the effect of the new Intrastromal abdominal hysterectomy
as a bloodless nerve-sparing method without disturbing the pelvic
support system, versus the conventional abdominal hysterectomy.
Additionally, to evaluate this method as an alternative procedure
to prevent blood loss and enable a shorter hospital stay with
fewer complications.
METHODS:
The hysterectomy can be performed using the following techniques
? conventional, abdominal, vaginal, or laparoscopic assisted
vaginal hysterectomy, intrafascial, extrafascial, and lastly
the supracervical hysterectomy. The supracervical hysterectomy
has been criticized in medical literature due to the number
of patients developing cancer in the cervical stump that may
lead to fatality. Moreover, it is important to acknowledge that
the supercervical hysterectomy is expensive, which is to be
attributed to the cost incurred as a result of the preventive
measures considered for cancer.
The new intrastromal T.A.H. keeps the cardinal, utereosacral
ligament, and vaginal apex unsevered. In the meantime, the entire
cervix's endocervical canal and the T-zone with uterus are removed,
whereas the bed and the pericervical stroma remain. In the outer
stroma of the cervix is a pericervical bed, and the cervix is
removed from this bed.
RESULTS:
There were differences in the average blood loss (
hemoglobin 1.0 versus 1.4 g/dl, P0.00l), and the average hospital
stay (2.7 days versus 3.15 days, P=0.005) was in favor of the
study group. There were no post-operation infections, ureter
injuries, vaginal vault prolapses, and no post-hysterectomy
fistula were seen.
CONCLUSION:
Intrastromal Abdominal Hysterectomy is a bloodless, nerve-sparing
technique that does not disturb the pelvic support system. It
also proves to be an effective alternative to the traditional
hysterectomy, with advantages such as reduced blood loss, shorter
hospital stay, and less frequent post-operation complications.
Throughout this process, it is imperative that the patient's
fear cervical cancer should not be ignored.
INTRODUCTION:
Historically, Langen Beck performed the first abdominal
hysterectomy in 1825. Porro first performed the subtotal casarean
hysterectomy successfully in 1876, where Wertheim perfbrmed
his first abdominal hysterectomy in 1898. Vaginal hysterectomy
was performed more than 250 years prior to the first abdominal
hysterectomy. Seventy percent (70%) of hysterectomies today
are abdominal[4] and thirty percent (30%) are vaginal. In traditional
hysterectomies, most surgeons remove the uterus by cutting the
uterosacral ligaments, the cardinal ligament of Mackenrodt,
and the uterine vessels prior to entering the vaginal fornix[2,5]
In this procedure, significant damage occurs to nerves in Franken
Hauser's nerve plexus, the vesical plexus, and other downstream
nerves. Additionally, the fibrous condensation in the endopelvic
fascia are severed and no longer support the vaginal vault[5,6].
Based upon these observations, a prospective randomized trial
was conducted to evaluate the extent of the effectiveness of
Intrastromal Abdominal Hysterectomy[22,24] to alleviate the
traditional concern about possible interference with sexual
or bladder function postoperatively [7,12,15] as well as blood
loss and length of hospital stay.
MATERIALS AND METHOD:
A total of forty (40) women were placed in this prospectively
randomized clinical trial of a new Intrastromal Abdominal Hysterectomy
procedure performed in the Department of Obstetrics and Gynecology
at Fountain Valley Regional Hospital and Huntington Beach Medical
Center. An informed consent was obtained from the participants
after a detailed explanation was provided to them.
The average age of the participating women was 50.6 years. Patients
were randomized into two groups ? the study group and the control
group. In the study group (n=20), Intrastromal Abdominal Hysterectomy
was performed, and in the control group (n=20), a conventional
hysterectomy was performed. All operations in the study were
performed by one surgeon in order to minimize any bias due to
differences in surgical technique and style.
Indications for hysterectomy were chronic pelvic pain, uterine
intramural or submucosal liomyoma, anemia, and pelvic endometriosis[9,11]
Prior to the surgery, all participants provided us with informed
consent, as well as each an agreement to have an annual check-up.
Then Intrastromal Abdominal Hysterectomy was performed in the
following manner: the patient's position on the operating table
must be wide gynecology position and the legs were placed in
Allen stirrups. The patient's perineum was four to six inches
below the edge of the table. The patient was draped to allow
access to the vaginal introitus. The majority of times, a low
transverse, and sometimes midline incision, was made.
Any surgical scar could be removed at that time. After the abdominal
cavity was entered, the examination and palpation were carried
out, and the bowel was packed away. The round ligaments were
severed on both sides about two cm. away from the carneal end
of the uterus. These severed ends were then ligated and, at
the same time, this opened the broad ligaments so that an anterior
vesical flap of peritoneum could be formed. If the adnexae were
to remain, an avascular area was found in the broad ligament
close to the uterus. This was entered with either a finger or
a curved clamp. The tube and the ovarian ligament were clamped,
severed and suture ligated, if the ovaries were to be removed,
the infundibulo pelvic ligament was clamped, severed, and suture
ligated from the side of the uterus.
 To perform the new technique, adequate vaso constrictive solution
must be injected into the peripheral portion of the cervix,
until ischmia in this area is observed. The cervical stroma
was then entered from the peripheral portion of the cervico
uterine junction, using a Thermo electric or Laser knife (Fig.
1). Dissection must be executed in a circular fashion. The peripheral
portion of the cervix or cervical bed must be protected[9] because
the ligamentous support system and the nerves are fused to the
outer portion of the cervix (Fig 2). Our endocervical guider
helps to identify the anatomy, at the time the incision is carried
into the vagina A purse string-type suture is used to draw the
remaining stroma together, and assists in hemostatsis. The repair
of any defect should start from the surgical margin of fornix,
toward the abdominal side (Fig. 3). Any active bleeding must
be controlled. The rest of the closing defect must be sutured
using the Kisner or Garcia technique. During closure, the round
ligaments are anchored to the middle of the vault. The raw surfaces
are carefully peritonealized. The outer stroma of the cervix
is like a bed, and the cervix is removed from this bed.
 In the control group, conventional abdominal hysterectomy was
performed. In this procedure, most surgeons removed the uterus
by cutting the uterosacral ligaments, the cardinal ligament
of Mackenrodt, and the uterine vessel prior to entering the
vaginal fomix[2,5,7]. The uterus was then severed from the vagina
in a circular fashion at the cervico-vaginal junction[2,5,15].
To access this area, the bladder was either pushed down or dissected
free of its attachments. In this procedure, significant damage
occurs to nerves in the Franken Hauser's nerve plexus, the vesical
plexus, and other downstream nerves [21,22,23,] Additionally,
the fibrous condensation in the endopelvic fascia was severed
and no longer supported the vaginal vault.
The following parameters were evaluated: Preoperative and postoperative
hemoglobin, hospital days, febrile morbidity, wound healing,
and readmission to the hospital due to ureter injury, vaginal
prolapse, or post-hysterectomy fistula.
RESULTS:
There are significant differences in favor of the study group
(as shown in Table I). Although patients in the study group
were older on the average (57.9 years of age), they recovered
more quickly than the patients in the control group, who were
younger on the average (49.3 years of age). Analyzing the hemoglobin
data in Table I clearly indicates that less blood was lost in
the study group. The data of the pre-hysterectomy control group,
when compared with the data of post-hysterectomy group, showed
a loss of 1.4 gldl (11.38%) hemoglobin, but data obtained from
the study group showed a loss of 1 g/dl (8%) hemoglobin, P0.OOl.
Moreover, there was also a significant difference in the number
of hospitalization days. On average, the patients in the control
group required longer hospitalization (3.15 days) than those
patients in the study group (2.7 days versus 3.15 days, P=0.005).
In the United States, 600,000 hysterectomies are performed each
year[20]. In Table II, we have attempted to extrapolate this
data, and show the impact on a national level. The total amount
of hemoglobin loss between the study group and the control group
is 6.9 gldl. Assuming the new technique was performed for all
hysterectomies performed in the United States during the year,
blood loss would be decreased by approximately 207,000 units.
Similarly, the total number of hospitalization days saved as
a result of the new technique would be 270,000 days, as shown
in Table II.
| Table
I - Study Data* |
| |
Study
Group (n=2O) |
Control
Group (n=20) |
| Patient
Age (y) |
52
(41 to 74) |
49.3 (43 to 64) |
| Hemoglobin
(g/dl) |
1.0
(0.1 to 2.4) |
1.4
(0.4 to 4.6) |
| Hospital
Stay (days) |
2.7
(2 to 3) |
3.15
(2to 5) |
| Patient
Weight (lbs.) |
177
(117 to 238) |
156
(107 to 205) |
*
Values are given in average and range.
| Table
II - Extrapolated Results* |
Extrapolated
Result
- 600,000
Hysterectomies Per Year
Total Loss |
| Study
Group (n=20) |
Control
Group (n=20) |
Prevented |
|
|
| Total
Hemoglobin (d/gl) |
20.1 |
27 |
6.9 |
27
6.9 207,000 units |
| Total
Hospital Stay |
54 |
63 |
9 |
270,000
days |
| (no.
of days saved) |
|
|
|
saved |
*post-hysterectomy values indicate differences between study
and control group, and extrapolated to 600,000 hysterectomies
performed annually in the United States.
DISCUSSION:
There are some reports in the literature that women
who undergo conventional hysterectomy are at a sixty percent
(60%) greater risk of developing urinary incontinence later
in life than those who have not had the procedure[6,7,18].
It is important to note that the uterosacral and cardinal
ligaments support the uterus and the cervix laterally and
posteriorly, respectively, and provide direct and indirect
supports to the bladder and urethra through these attachments.
The primary function of these suspensory mechanisms is to
support the upper urethra and urethrovesical junction[9].
Meanwhile, the fascia of the bladder and the anterior vaginal
wall fuse to form the pubocervical fascia. At the level
of the bladder neck and proximal urethra, and at the level
of the bladder and the fuscial ring of the cervix, these
two fascia are densely adherent. Along the base of the bladder,
vesicovaginal space can be developed between these two fascial
planes.
The pubocervical fascia prevents herniation of the bladder
and urethra into the vagina[19]. The procedure may lead
to chronic or progressive damage of the pelvic nervous system,
or pelvic supportive structure that results in incontinence
years later sometimes can have a negative impact on their
sexuality. Cutting the vaginal apex disturbs the vaginal
nerves function[2,5]. The Intrastromal Abdominal Hysterectomy
procedure is proposed as an alternative to those patients
concerned with sexual and bladder dysfunction. During the
procedure, neither the cardinal ligaments nor the uterosacral
ligaments are severed, thus avoiding injury to the Franken
Hauser's nerve plexus[2,8,9]. Note that the outer stroma
of the cervix is pericervical bed, and the cervix is removed
from this bed. This method is helpful for the prevention
of future cervical cancer. The pathological specimen and
report confirmed the endocervical, and the exocervic was
removed along with the uterus. To refresh your memory, supracervical
hysterectomy[3,8] provide no protection against cervical
cancer.
According to medical literature, supracervical hysterectomy
is costly[20,25,26] and has a negative financial impact
on the health care system. it is hoped the new hysterectomy
will result in fewer postoperative problems relating to
urinary function, sexual function, blood loss, and ureteric
injury. The reduced trauma described is very consistent
with the surgical principle of keeping dissection and, therefore,
injury to a minimum. This technique and research is related
to the abdominal method however other techniques have limitations[10,13,14]
and cannot be used for all patients. Abdominal hysterectomy
can be used for all patients. Specialized training is required
to perform this technique.
References
1. Shaw¡¯s textbook of Operative Gynecology, Fourth Edition.
2. R Warwick; R. Williams; RE. Moore; L.K. Dannister; S.M.
Standing;
E.L. Rees, et al: Philadelphia, W.B. Sanders Company, 1980.
3. R Cliffor: Wheeless Jr. Atlas of Pelvic Surgery. 1981.
4. Philippe Elliote; Josephine Barns; Michael Newton:
Scientific Foundations of Obstetrics and Gynecology. 1986.
5. Daniel R. Mishell, Jr.; Arthur L. Herbst; William Droegmiller;
Morton A. Stenchever: Comprehensive Gynecology. The C.V.
Mosby Company, 1987.
6. John A. Rok; John D. Thompson: TeLinde¡¯s Operative Gynecology,
Seventh Edition. 1992.
7. L. Heistrom, M.D.; P.O. Lundberg, M.ID., Ph.D.; D. Sorbom,
Ph.D., M.D.;
T. Backstrom, M.D., Ph.D.: Sexuality After Hysterectomy.
Obstetrics & Gynecology, March 1993.
8. D. Poad; E.P. Arnold: Sexual Function After Pelvic Surgery
in Women.
Aug. A2 J Ob-Gyn, 1994.
9. Paul F Vietz,M.D, T ,S.Mn Am J Obstet Gynecol Feb.1994.
10. Mary B. Harris, M.D.; David L. Olive, M.D.:
Changing Hysterectomy Patterns After Introduction of Laparoscopically
Assisted Vag Hysterectomy.
11. James H. Dorsey, M.D.; Earl Steinberg, M.D., M.P.P.;
Patrice Holtz: Clinical Indications for Hysterectomy Route.
Patient Characteristics or Physician Preference.
AM J Obstetrics-Gynecology, Nov. 1995.
12. Richard Scotti, Dept. of OB-GYN, Albert Einstein College
of Medicine:
Should Hysterectomy be Performed at the Time of Reconstructive
Surgery. 1997.
13. Robert L. Summitt, Jr., M.D.; Thomas G. Stovall, M.D.;
John F. Steege, M.D.;
Gary H. Lipscomb, M.D.: Multicenter Randomized Comparison
of
LAPAROSCOPY ASSISTED VAGINAL HYSTERECTOMY and ABD Hysterectomy
Candidates.
Obstetrics & Gynecology, Sept. 1998.
14. Tonimasco Facone, M.D.; Marie Fidela R Paraiso, M.D.:
Prospective Randomized Clinical Trial of Laparoscopically
Assisted Vaginal
Hysterectomy Versus Total Abdominal Hysterectomy.
AM J Obstet. Gyneco, April 1999.
15. Mellissa K. Rowe, Ph.D.; David El Kandouse, Ph.D.; Biam
Smittman, M.D.;
Steven S. Bernstein, M.D., M.P.H.: Quality of Life Among
Women Undergoing
Hysterectomies. Obstetrics & Gynecology, June 1999.
16. Jeanette S. Brown; George Sawaya; David H. Thom; Deborah
Grady:
Hysterectomy and Urinary Incontinence ? A Systematic Review.
The Lancet V.356, Aug. 12, 2000.
17. Hysterectomy and Urinary Incontinence. OB-GYN News,
Oct. 2000.
18. Rodolphe Maheux, Dept. of OB-GYN Laval University, Quebec
City, Editorial Guest:
The Case for Keeping the Cervix. OB-GYN News, Dec. 15, 2000.
19. Alan J. Wein, M.D.; David M. Barrett, M.D.: Voiding
Function and Dysfunction.
Year Book Medical Publishing, Inc.
20. Cynthia M. Faruhar, M.D.; Claudia A. Steiner, M.D.:
Hysterectomy Rate in the United States.
Obstetrics-Gynecology, V99 No. 2, Feb. 2002.
21. Dary Saminii, M.D.: The Closed Burch Procedure ? Outpatient
?
With No Laparotomy or Laproscopy. ACOG, ACM, New Orleans,
1998.
22. Dary Samimi, M.D, Performing a bloodless, Nerve Sparing,
TAH,
Society for Gynecologic Investigation, Los Angeles, Feb
2002.
23. Dary Samimi, M.D.: Outpatient Burch-Sling Procedure
-
A Nerve Sparing Method for Correction of Female Urinary
Incontinence.
(AVL 160) American College of Obstetrics and Gynecology,
Annual Clinical Meeting, Los Angeles, 2002.
24. Dary Samimi, M.D.: Randomized Clinical Tnal of Intrastromal
Abdominal Hysterectomy,
Bloodless Nerve Sparing TAR American College of Obstetrics
and Gynecology,
AnnuaL Clinical Meeting, New Orleans, 2003.
25. Thomas C. Wright Jr., M.D., Mark Schithnan, M.D., MPH,
Diane Solomon, M.D.,
Thomas Cox, M.D., Francisco Garcia, M.D. MPH, Sue Goldie.
M.D., MPH, Kenneth Hatch,
M.D., Kenneth L. Noller, M.D., Nancy Roach, Carolyn Runowicz,
M.D.,
and Debbie Saslow, PhD.: Interim Guidance for the Use of
Human Papillomavirus
DNA Testing as an Adjunct to Cervical Cytology for Screening,
Obstetrics
and Gynecology, Volume 103, Number 2, February 2005.
26. Comelia L. Trimble, M.D., Lynn A. Richards, RN., Barbara
Wilgus-Wegweiser,
C.RN.P., Karen Plowden, B.A., Dorothy L. Rosenthal, M.D.,
and Ann Klassen, PhD.
Obstetrics and Gynecology, Volume 103, Number 2, February
2005.
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