Clinical Trials Directory

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UnknownNCT02308995

Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

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

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Aljazeera Hospital · Academic / Other
Sex
Female
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECystectomy using barbed suturesA 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).
PROCEDURECystectomy using conventional suturesA 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) .
DEVICEV-Loc (Covidien, Mansfield, MA)
DEVICEpolyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)

Timeline

Start date
2014-12-01
Primary completion
2016-03-01
Completion
2016-03-01
First posted
2014-12-05
Last updated
2016-01-29

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02308995. Inclusion in this directory is not an endorsement.