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To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.
The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bakay purse string group | Active Comparator | Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions. |
|
| Cuff closure via vaginal route group | Active Comparator | Vaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bakay purse string | Procedure | After developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments. |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | The time between placement of the operative ports and successful closure of the vaginal cuff | From start to end of operation |
| Operative time for colpotomy and vaginal cuff closure | The time between first anchor suture placement and successful closure of the vaginal cuff | From start colpotomy to end of vaginal cuff closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Elashry, MSc | Contact | +201066556370 | elashry11090@gmail.com | |
| Mohamed S Abdelhafez, MD | Contact | msabdelhafez@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Elashry, MSc | Mansoura University | Principal Investigator |
| Hamed M Youssef, MD | Mansoura University | Study Chair |
| Maged R Elshamy, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Department in Mansoura University Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Cuff closure via vaginal route group | Procedure | After the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer. |
|
| Mansoura University |
| Study Director |
| Mahmoud M Awad, MD | Mansoura University | Study Director |
| Mohamed S Abdelhafez, MD | Mansoura University | Study Director |
| D000091662 | Genital Diseases |