An interventional study of Hysterectomy in Hysterectomy and Laparoscopy, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 52 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The presence of perimenopausal bleeding
Exclusion Criteria:
The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.
Procedure: Hysterectomy
The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.
Procedure: Hysterectomy
Total Laparoscopic Hysterectomy Total Abdominal hysterectomy
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
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.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Ain Shams Maternity Hospital