Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02308995
• Other study ID #: lap.cystectomy.barbed
• Status: Recruiting
• Phase: Phase 2
• First received: December 3, 2014
• Last updated: January 28, 2016
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Aljazeera Hospital
• Contact: Usama M Fouda, M.D,PhD
• Phone: 01095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• Cystectomy using barbed sutures
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).
• Cystectomy using conventional sutures
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) .

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

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

Locations

Country	Name	City	State
Egypt	Aljazeera hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Aljazeera Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suturing time of endometrioma bed		During cystectomy operation	No
Secondary	Operative time		During cystectomy operation	No