The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.
Research Questions: Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia? Research Hypothesis: In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Total Laparoscopic Hysterectomy Total Abdominal hysterectomy
Ain Shams Maternity Hospital
Cairo, Egypt
Operative time
Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.
Time frame: From skin incision till closure of the vault "up to 4 hours".
Blood loss
Intra operative blood loss will be estimated via: 1. Amount of blood in the suction bottle. 2. Estimation will be based on number of soaked gauzes and towels (soaked gauze = 20 ml blood; soaked towel = 150 ml; semi soaked towel = 75 ml).
Time frame: From skin incision start until skin suturing is finished "up to 4 hours".
Blood transfusion
The need to blood transfusion to the patient.
Time frame: From admission to the hospital until the home discharge "up to 1 week".
Postoperative pain
Assessment of pain intensity using Visual Analog Scale (VAS) which is one-dimensional measure of pain intensity. It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100).
Time frame: 8 hours after the end of operation.
Hospital stay
Hospital stay duration in days.
Time frame: From admission to the hospital until the home discharge "up to 1 week".
Incidence of operative complications
The need for laparotomy, and bowel or bladder or ureteric injury.
Time frame: During operation.
Incidence of postoperative complications
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Morbidities e.g.: * Vaginal vault hematoma or pelvic hematoma or abscess. * Surgical site infection. * Urinary tract infection. * Need for post-operative blood transfusion. * Postoperative bowel or urinary tract complications.
Time frame: Up to 1 week postoperative.