Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

Phase 2

• Conditions: Endometriosis
• Interventions: 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)

• Registration Number: NCT02308995
• Lead Sponsor: Aljazeera Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Unilateral endometrioma more than 3 cm in mean diameter

Exclusion Criteria

• Bilateral endometriomata
• Conversion of laparoscopy to laparotomy
• Contraindications for general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystectomy using barbed sutures	Cystectomy using barbed sutures	Endometrioma bed is sutured with barbed sutures
Cystectomy using conventional sutures	Cystectomy using conventional sutures	Endometrioma bed is sutured with conventional sutures
Cystectomy using barbed sutures	V-Loc (Covidien, Mansfield, MA)	Endometrioma bed is sutured with barbed sutures
Cystectomy using conventional sutures	polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)	Endometrioma bed is sutured with conventional sutures

Primary Outcome Measures

Name	Time	Method
Suturing time of endometrioma bed	During cystectomy operation

Secondary Outcome Measures

Name	Time	Method
Operative time	During cystectomy operation

Trial Locations

Locations (1)

Aljazeera hospital; 🇪🇬 Giza, Egypt