Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions

Conditions
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Uterine Diseases

Intervention / Treatment
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* Procedure: Bakay purse string
* Procedure: Cuff closure via vaginal route group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Benign uterine lesions e.g fibroid, adenomyosis,…etc. Patient acceptance to undergo laparoscopic hysterectomy. Exclusion Criteria: Gynecological malignancy. Low corporeal myoma obsecuring cervicovaginal junction. History of extensive abdominal surgery other than cesarean section.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bakay purse string group<br>Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions. | Procedure: Bakay purse string<br>* 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.<br>|
| Active Comparator: Cuff closure via vaginal route group<br>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. | Procedure: Cuff closure via vaginal route group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TLH, Bakay purse string