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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Laparoscopic Hysterectomy | Active Comparator | The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy. |
|
| Total Abdominal hysterectomy | Active Comparator | The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysterectomy | Procedure | Total Laparoscopic Hysterectomy Total Abdominal hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures. | From skin incision till closure of the vault "up to 4 hours". |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | Intra operative blood loss will be estimated via:
| From skin incision start until skin suturing is finished "up to 4 hours". |
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Inclusion Criteria:
The presence of perimenopausal bleeding
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid E Mohammed, MD | Ain Shams Maternity Hospital | Study Director |
| Mortada E Ahmed, MD | Ain Shams Maternity Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Cairo | Egypt |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 10, 2018 | |
| Reset | Mar 7, 2019 | |
| Release | Mar 10, 2019 | |
| Reset | Jun 7, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 10, 2018 | Mar 7, 2019 | |||
| Mar 10, 2019 |
| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Blood transfusion |
The need to blood transfusion to the patient. |
| 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). | 8 hours after the end of operation. |
| Hospital stay | Hospital stay duration in days. | 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. | During operation. |
| Incidence of postoperative complications | Morbidities e.g.:
| Up to 1 week postoperative. |
| Jun 7, 2019 |