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Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

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ClinicalTrials.gov Identifier: NCT02308995
Recruitment Status : Unknown
Verified January 2016 by Prof .Usama M.Fouda, Aljazeera Hospital.
Recruitment status was:  Recruiting
First Posted : December 5, 2014
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Prof .Usama M.Fouda, 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.

Condition or disease Intervention/treatment Phase
Endometriosis 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) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma . A Randomized Controlled Study
Study Start Date : December 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Cystectomy using barbed sutures
Endometrioma bed is sutured with barbed sutures
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).

Device: V-Loc (Covidien, Mansfield, MA)
Active Comparator: Cystectomy using conventional sutures
Endometrioma bed is sutured with conventional sutures
Procedure: 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: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)



Primary Outcome Measures :
  1. Suturing time of endometrioma bed [ Time Frame: During cystectomy operation ]

Secondary Outcome Measures :
  1. Operative time [ Time Frame: During cystectomy operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308995


Contacts
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Contact: Usama M Fouda, M.D,PhD 01095401375 ext +2 umfrfouda@yahoo.com

Locations
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Egypt
Aljazeera hospital Recruiting
Giza, Egypt
Contact: Usama M. Fouda, M.D, PhD    01095401375 ext +2    umfrfouda@yahoo.com   
Principal Investigator: Usama M. Fouda, M.D, PhD         
Sponsors and Collaborators
Aljazeera Hospital
Investigators
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Study Chair: Usama M Fouda, M.D,PhD Aljazeera Hospital
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Responsible Party: Prof .Usama M.Fouda, M.D, PhD, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT02308995    
Other Study ID Numbers: lap.cystectomy.barbed
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Prof .Usama M.Fouda, Aljazeera Hospital:
Endometriosis
Laparoscopy
Barbed sutures
Additional relevant MeSH terms:
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Endometriosis