Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

Study Overview
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Brief Summary
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The aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

Detailed Description
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Several authors reported the use of barbed sutures in myomectomy , hysterectomy and closure of vaginal vault. A recent meta-analysis comparing the efficacy of laparoscopic suturing using barbed suture or conventional sutures in myomectomy or hysterectomy revealed that suturing with barbed sutures was associated with less suturing time and operative time. Although numerous studies revealed the advantages of using barbed sutures , no studies have yet evaluated the use of barbed sutures in laparoscopic excision of endometrioma. The aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

Official Title
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Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma . A Randomized Controlled Study

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: Cystectomy using barbed sutures
* Procedure: Cystectomy using conventional sutures
* Device: V-Loc (Covidien, Mansfield, MA)
* Device: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral endometrioma more than 3 cm in mean diameter Exclusion Criteria: Bilateral endometriomata Conversion of laparoscopy to laparotomy Contraindications for general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystectomy using barbed sutures<br>Endometrioma bed is sutured with barbed sutures | Procedure: Cystectomy using barbed sutures<br>* A sharp transverse cortical incision was made over the endometroma using unipolar hook and a cleavage plane was developed by sharp dissection. After the identification of the cleavage plane, the entire cyst will be enucleated by means of adequate traction with a strong grasper and counter-traction maneuvers with another grasping forceps . The ovarian edges will be re-approximated by using V-Loc (Covidien, Mansfield, MA).<br>Device: V-Loc (Covidien, Mansfield, MA)<br> <br> |
| Active Comparator: Cystectomy using conventional sutures<br>Endometrioma bed is sutured with conventional sutures | Procedure: Cystectomy using conventional sutures<br>* A sharp transverse cortical incision was made over the endometroma using unipolar hook and a cleavage plane was developed by sharp dissection. After the identification of the cleavage plane, the entire cyst will be enucleated by means of adequate traction with a strong grasper and counter-traction maneuvers with another grasping forceps . The ovarian edges will be re-approximated by using polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .<br>Device: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suturing time of endometrioma bed |  | During cystectomy operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | During cystectomy operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Laparoscopy, Barbed sutures