Forty women were enrolled in this study. The study group consisted of 20 patients who underwent ISTAH-BSO performed by a single surgeon (DS) at Fountain Valley Regional Hospital over a 2-year period. Inclusion criteria included both medically and surgically stable patients presenting with symptoms that, in the opinion of the gynecologist and patient, justified hysterectomy. Indications for hysterectomy were intramural or submucosal uterine leiomyoma, anemia, chronic menorrhagia, chronic metrorrhagia, amenorrhea, and pelvic endometriosis.5
Written informed consent was obtained from all women who agreed to participate in the study and to attend a follow-up visit one year later. Exclusion criteria included medically and/or surgically unstable patients. Patients with a recent history of alcohol or narcotic use as determined by preoperative assessment were excluded from the study.
Outcomes in the study group were compared with outcomes in a control group of 20 patients who had undergone conventional abdominal hysterectomy procedures performed by the same surgeon at Fountain Valley Regional Hospital.1
The study protocol was approved by the Central Investigational Review Board.
The founder of randomized controlled trials (Fisher) first introduced the idea of randomization, the academic community has deemed randomization an essential tool for unbiased comparisons of treatment groups.11
Five years after Fisher’s introductory paper, the first randomized controlled trial involving tuberculosis was conducted involving a total of 24 participants that were each paired (ie, 12 comparable pairs) by randomization. In our study, both the control group and study group candidates were chosen by a block randomization method. This randomization method was chosen to produce a sample size with balanced baseline characteristics between the treatment and control groups.
The ISTAH-BSO is performed as follows. The patient is placed comfortably in Allen stirrups with the buttocks brought to the edge of the “broken” operating table. The knees are separated about 90 degrees. The thighs are elevated relative to the abdomen. The patient is draped to allow access to the vaginal introitus and external urethral meatus.6
In most cases, a low transverse incision is made. In rare cases, a midline incision is utilized. Any existing surgical scar tissue is removed at that time. After the abdominal cavity is entered, an examination and palpation is carried out, and the bowel is packed out of the way.
The round ligaments are severed on both sides about 2 cm away from the cornual end of the uterus. These severed ends are then ligated. This manipulation concurrently opens the broad ligaments so that an anterior vesical flap of peritoneum can be formed. If the adnexae are to remain intact, an avascular area is found in the broad ligament near the uterus. This area is entered with either a finger or a curved clamp. The tube and the ovarian ligament are clamped, severed, and ligated with a suture. If the ovaries are to be removed, the infundibulopelvic ligament is clamped, severed, and ligated with a suture from the side of the uterus. After the main uterine vessels are skeletonized, they are triple-clamped and cut bilaterally. The lowest clamp is placed first below the level of the internal os and positioned at a right angle to the lower uterine isthmus. The other two clamps are secured by No 0 delayed absorbable suture ligatures.
To perform ISTAH-BSO, a vasopressin solution is diluted with sterile normal saline to a final concentration of 0.4 U/mL. The vasopressin solution is then injected into the peripheral portion of the cervix (transabdominally) until blanching in this area is observed. Using a thermo-electric or laser knife, a circumferential incision is made just cephalad to the pericervical ring and stroma at the level of the ligated uterine arteries, below the internal os or isthmus ( and ).9
The incision must be performed by cutting and sometimes coagulation in the case of bleeding. The pericervical ring and peripheral portion of the cervix must be protected ().3
The circumferential incision must travel through the pericervical ring and stroma until the epithelium of the fornix is visualized. The closing suture must be fixed immediately to the surgical margin of the fornix. Cutting and suturing must be performed by a continuous interlocking technique. Bleeding is controlled by mild to moderate traction of the uterus. The uterus, cervix, and cervical guider will be removed altogether abdominally.
Transverse cut presentation nerve sparing hysterectomy.
Vertical presentation nerve sparing hysterectomy.
A cervical guider (patent pending) is used to assist in the navigation of the pericervical ring during the procedure. The cervical guider is a small disposable device used to protect and guide the cervical direction. This device is placed on the cervix prior to initialization of ISTAH-BSO.
Closure of the vaginal fornix is accomplished by a continuous suturing technique. The rest of the closure is performed from the vaginal side toward cephalad by using a spiral technique all through the abdominal side. After the upper margin of the pericervical ring is closed, the intact cardinal ligaments, uterosacral ligaments, and endopelvic fascia are reinforced by round ligaments. The peritoneal flaps are raised and their surfaces are covered. Adequate instruction and training is necessary to perform this hysterectomy method.
In the control group, conventional abdominal hysterectomy was performed. In this procedure, the uterus was removed by cutting the uterosacral ligaments, the cardinal ligament of Mackenrodt, and the uterine vessel before entering the vaginal cavity.8
The uterus was then severed from the vagina in a circular manner at the cervicovaginal junction.1
To access this area, the bladder was either pushed down or dissected free of its attachments.