NCT02166411

Brief Summary

The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 13, 2020

Status Verified

October 1, 2019

Enrollment Period

5 years

First QC Date

June 16, 2014

Last Update Submit

March 12, 2020

Conditions

Fibroid

Keywords

Myomectomy ,Laparoscopy , Barbed sutures

Outcome Measures

Primary Outcomes (1)

  • Operative time

    During myomectomy operation

Secondary Outcomes (1)

  • Suturing time of myoma bed

    During myomectomy operation

Study Arms (2)

myomectomy using barbed sutures

EXPERIMENTAL

.Myoma bed is sutured with barbed sutures

Procedure: myomectomy using barbed sutures

myomectomy using conventional sutures

ACTIVE COMPARATOR

Myoma bed is sutured with conventional sutures

Procedure: myomectomy using conventional sutures

Interventions

myomectomy using barbed suturesPROCEDURE

A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . The myometrial edges will be reapproximated in one or two layers (according to the depth of the uterine wound) by using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).

myomectomy using barbed sutures
myomectomy using conventional suturesPROCEDURE

A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . Myometrial edges will be re-approximated using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ)

myomectomy using conventional sutures

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).

You may not qualify if:

  • submucosal myoma
  • calcified myomas
  • uterine size more than 16 weeks
  • suspension of genital malignancy
  • coagulation defects or concurrent anticoagulant therapy
  • pregnancy
  • compromised cardiopulmonary status
  • previous treatment with gonadotropin-releasing hormone analogue
  • contraindications for general anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university

Cairo, Egypt

Location

Related Publications (1)

  • Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.

    PMID: 18619922BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Mohamed Zayed, M.D,PhD

    Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

    STUDY CHAIR

  • Usama M Fouda, M.D,PhD

    Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

    STUDY DIRECTOR

  • Khaled A Elsetohy, M.D,PhD

    Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

    PRINCIPAL INVESTIGATOR

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

June 16, 2014

First Posted

June 18, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

March 13, 2020

Record last verified: 2019-10

Locations

EG(1)