Hysterectomy, Laparoscopy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHysterectomy
Total Laparoscopic Hysterectomy Total Abdominal hysterectomy
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
The presence of perimenopausal bleeding * Early stage endometrial carcinoma. * Endometrial hyperplasia with/without atypia.
Exclusion criteria
* Obese patients i.e., BMI\< 29 k.g/m2. * Patients unfit for laparoscopy as patients with cardio-pulmonary compromise. * Presence of adnexal mass. * End stage endometrial carcinoma stage 3 & 4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | From skin incision till closure of the vault up to 4 hours. | Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion | From admission to the hospital until the home discharge up to 1 week. | The need to blood transfusion to the patient. |
| Postoperative pain | 8 hours after the end of operation. | 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). |
| Blood loss | From skin incision start until skin suturing is finished up to 4 hours. | 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). |
| Incidence of operative complications | During operation. | The need for laparotomy, and bowel or bladder or ureteric injury. |
| Incidence of postoperative complications | Up to 1 week postoperative. | 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. |
| Hospital stay | From admission to the hospital until the home discharge up to 1 week. | Hospital stay duration in days. |
Countries
Egypt
Outcome results
None listed