Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

Aljazeera Hospital

Status and phase: Unknown; Phase 2

Conditions: Endometriosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02308995

lap.cystectomy.barbed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral endometrioma more than 3 cm in mean diameter

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cystectomy using barbed sutures

Experimental group

Description:

Endometrioma bed is sutured with barbed sutures

Treatment:

Procedure: Cystectomy using barbed sutures

Device: V-Loc (Covidien, Mansfield, MA)

Cystectomy using conventional sutures

Active Comparator group

Description:

Endometrioma bed is sutured with conventional sutures

Treatment:

Device: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)

Procedure: Cystectomy using conventional sutures