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Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cystectomy using barbed sutures
Cystectomy using conventional sutures
V-Loc (Covidien, Mansfield, MA)
polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)
Sponsored by
Aljazeera Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Laparoscopy, Barbed sutures

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Aljazeera hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cystectomy using barbed sutures

Cystectomy using conventional sutures

Arm Description

Endometrioma bed is sutured with barbed sutures

Endometrioma bed is sutured with conventional sutures

Outcomes

Primary Outcome Measures

Suturing time of endometrioma bed

Secondary Outcome Measures

Operative time

Full Information

First Posted
December 3, 2014
Last Updated
January 28, 2016
Sponsor
Aljazeera Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02308995
Brief Title
Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma
Official Title
Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma . A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aljazeera Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Laparoscopy, Barbed sutures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cystectomy using barbed sutures
Arm Type
Experimental
Arm Description
Endometrioma bed is sutured with barbed sutures
Arm Title
Cystectomy using conventional sutures
Arm Type
Active Comparator
Arm Description
Endometrioma bed is sutured with conventional sutures
Intervention Type
Procedure
Intervention Name(s)
Cystectomy using barbed sutures
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Cystectomy using conventional sutures
Intervention Description
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) .
Intervention Type
Device
Intervention Name(s)
V-Loc (Covidien, Mansfield, MA)
Intervention Type
Device
Intervention Name(s)
polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)
Primary Outcome Measure Information:
Title
Suturing time of endometrioma bed
Time Frame
During cystectomy operation
Secondary Outcome Measure Information:
Title
Operative time
Time Frame
During cystectomy operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral endometrioma more than 3 cm in mean diameter Exclusion Criteria: Bilateral endometriomata Conversion of laparoscopy to laparotomy Contraindications for general anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Usama M Fouda, M.D,PhD
Phone
01095401375
Ext
+2
Email
umfrfouda@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, M.D,PhD
Organizational Affiliation
Aljazeera Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aljazeera hospital
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usama M. Fouda, M.D, PhD
Phone
01095401375
Ext
+2
Email
umfrfouda@yahoo.com
First Name & Middle Initial & Last Name & Degree
Usama M. Fouda, M.D, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

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