Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy
Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.
Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.
Primary outcomes: (1) Operation Time.
Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional abdominal hysterectomy | No Intervention | The surgical technique of conventional abdominal hysterectomy was described in the literature. | |
| Manipulator-assisted Abdominal Hysterectomy | Other | In manipulator-assisted abdominal hysterectomy tecnique, a uterine manipulator (SecuFix ® , Richard Wolf) was inserted into the cervix. Conventional hysterectomy steps were performed until the vaginal colpotomy incision. A circular colpotomy incision was made directly over the manipulator silicone cup using a monopolar cautery set at 30W cutting mode without interfering with the cardinal ligament or sacrouterine ligament. The vaginal cuff was sutured using polyglactin 910 (no:1) as a single layer running suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manipulator-assisted Abdominal Hysterectomy | Procedure | Manipulator-assisted Abdominal Hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the surgical procedure | The surgical operative time was defined as the time from incision to completion of wound closure, also known as 'cut-to-close' time. In the manipulator-assisted abdominal hysterectomy group, the time of uterine manipulator placement was added to the operation time | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain at 6th hours | Postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain. | At the 6th hours after the surgical procedure |
| Postoperative pain at 24th hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Lütfi Kırdar City Hospital | Istanbul | 34000 | Turkey (Türkiye) |
Upon request, after the work is published
Upon request, after the work is published, 5 years
Upon request, after the work is published, 5 years
Not provided
Not provided
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain. |
| At the 24th hours after the surgical procedure |
| intraoperative complications | Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery | Intraoperative |
| Postoperative complications | Any minor and major complications (e.g., bowel injury, haematoma, infection, dyspareunia, vaginal pain, sexual discomfort) that occur in the first month of the surgery. | Postoperative, in the first month of the surgery |