EndometriosisPhase 2NCT02308995
Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma
A Phase 2 study testing Cystectomy using barbed sutures, Cystectomy using conventional sutures and V-Loc (Covidien, Mansfield, MA) in people with Endometriosis, run by Aljazeera Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Cystectomy using barbed sutures, Cystectomy using conventional sutures and V-Loc (Covidien, Mansfield, MA)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2014to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral endometrioma more than 3 cm in mean diameter
Who cannot join
- Bilateral endometriomata
- Conversion of laparoscopy to laparotomy
- Contraindications for general anesthesia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aljazeera hospital
Giza, Giza Governorate
Usama M. Fouda, M.D, PhD, 01095401375 ext. +2, umfrfouda@yahoo.com
Usama M. Fouda, M.D, PhD
About this study
Official title: Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma . A Randomized Controlled Study
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.
Read the 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
- Endometriosis
- Being tested
- Cystectomy using barbed sutures, Cystectomy using conventional sutures, V-Loc (Covidien, Mansfield, MA), polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)
- Keywords
- Endometriosis, Laparoscopy, Barbed sutures
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystectomy using barbed suturesProcedure or surgery
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).
Cystectomy using conventional suturesProcedure or surgery
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) .
V-Loc (Covidien, Mansfield, MA)Device
polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)Device
| Study group | Role | What they receive |
|---|---|---|
| Cystectomy using barbed sutures | Experimental | Endometrioma bed is sutured with barbed sutures Receives: Procedure: Cystectomy using barbed sutures; Device: V-Loc (Covidien, Mansfield, MA) |
| Cystectomy using conventional sutures | Active comparator | Endometrioma bed is sutured with conventional sutures Receives: Procedure: Cystectomy using conventional sutures; Device: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suturing time of endometrioma bed
Measured: During cystectomy operation
Secondary outcomes (1)
Operative time
Measured: During cystectomy operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof .Usama M.Fouda, Aljazeera Hospital
- Investigators
- Usama M Fouda, M.D,PhD, Study chair, Aljazeera Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308995
- Sponsor's protocol ID
- lap.cystectomy.barbed
- Status last verified
- Jan 2016
- First submitted
- 3 Dec 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma . A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02308995
- Acronym / sponsor ID
- lap.cystectomy.barbed
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Laparoscopy, Barbed sutures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystectomy using barbed sutures | Experimental | Procedure: Cystectomy using barbed sutures, Device: V-Loc (Covidien, Mansfield, MA)Endometrioma bed is sutured with barbed sutures |
| Cystectomy using conventional sutures | Active comparator | Procedure: Cystectomy using conventional sutures, Device: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)Endometrioma bed is sutured with conventional sutures |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unilateral endometrioma more than 3 cm in mean diameter
Key exclusion criteria (3 listed)
- Bilateral endometriomata
- Conversion of laparoscopy to laparotomy
- Contraindications for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cystectomy 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). | Procedure or surgery | Cystectomy using barbed sutures |
| Cystectomy 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) . | Procedure or surgery | Cystectomy using conventional sutures |
| V-Loc (Covidien, Mansfield, MA) | Device | Cystectomy using barbed sutures |
| polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ) | Device | Cystectomy using conventional sutures |
Primary outcome
Suturing time of endometrioma bed
Time frame: During cystectomy operation
1 secondary outcome
Operative time
Time frame: During cystectomy operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Usama M Fouda, M.D,PhD study chair
Aljazeera Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cystectomy using barbed sutures, Cystectomy using conventional sutures and V-Loc (Covidien, Mansfield, MA) in people with Endometriosis, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Usama M Fouda, M.D,PhD (01095401375 ext. +2, umfrfouda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suturing time of endometrioma bed (time frame: During cystectomy operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.