Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 3, 2014
CompletedFirst Posted
Study publicly available on registry
December 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 29, 2016
January 1, 2016
1.2 years
December 3, 2014
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Suturing time of endometrioma bed
During cystectomy operation
Secondary Outcomes (1)
Operative time
During cystectomy operation
Study Arms (2)
Cystectomy using barbed sutures
EXPERIMENTALEndometrioma bed is sutured with barbed sutures
Cystectomy using conventional sutures
ACTIVE COMPARATOREndometrioma bed is sutured with conventional sutures
Interventions
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).
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) .
Eligibility Criteria
You may qualify if:
- Unilateral endometrioma more than 3 cm in mean diameter
You may not qualify if:
- Bilateral endometriomata
- Conversion of laparoscopy to laparotomy
- Contraindications for general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aljazeera hospital
Giza, Giza Governorate, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Usama M Fouda, M.D,PhD
Aljazeera Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D, PhD
Study Record Dates
First Submitted
December 3, 2014
First Posted
December 5, 2014
Study Start
December 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 29, 2016
Record last verified: 2016-01