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This site is devoted to the presentation of techniques in nerve sparing gynecologic surgery pioneered by Dr. Dary Samimi, M.D., F.A.C.O.G. These techniques are done as an outpatient surgical procedure sometimes under local anesthesia. These techniques and the medical device(s) used to assist with the procedure, were created and patented by Dr. Dary Samimi, M.D., F.A.C.O.G., research-Invention, of Fountain Valley, California, USA. [US Patent for the 'Bladder Saver Retropublic Ligature Carrier Device'] ... read more...

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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.

DARY SAMIMI, M.D., ET. AL.
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California

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.

A total of forty women were placed in this prospectively randomized clinical trial of the Intrastromal Abdominal Hysterectomy. Patients were randomized into two groups. In the study group (n=20), Intrastromal Abdominal Hysterectomy was performed from May 2000 — Sept 2001. In the control group (n=20), a conventional hysterectomy was performed, before April 2000.

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     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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