Total Laparoscopic HysterectomyNCT02293369
Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy
A study testing Cuff closure via vaginal route and Cuff closure via laparoscopic route in people with Total Laparoscopic Hysterectomy and Benign Conditions, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs. Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Total Laparoscopic Hysterectomy, Benign Conditions
- What is being tested?
- Cuff closure via vaginal route and Cuff closure via laparoscopic route
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2014to Nov 2015
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only
Who cannot join
- Suspicion of malignancy
- Presence of large adnexal masses (maximum diameter >10 cm at preoperative ultrasonography)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Obstetrics and Gynecology, Istanbul University School of Medicine
Istanbul, 34093
About this study
Official title: Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy and Their Effect on Female Sexual Function and Vaginal Length
American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs.
Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.
Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.
- Conditions
- Total Laparoscopic Hysterectomy, Benign Conditions
- Being tested
- Cuff closure via vaginal route, Cuff closure via laparoscopic route
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuff closure via vaginal routeProcedure or surgery
Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.
Cuff closure via laparoscopic routeProcedure or surgery
Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Cuff closure via vaginal route | Active comparator | For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite and will continue toward the surgeon until the other uterosacral ligament will be incorporated into the repair, using a continuous 0-Vicryl suture in the vaginal route. Receives: Procedure: Cuff closure via vaginal route |
| Cuff closure via laparoscopic route | Active comparator | For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. In the laparoscopic approach, needles will be introduced through the umbilical trocar and removed through the peripheral trocars and intracorporeal knots will be utilized. Receives: Procedure: Cuff closure via laparoscopic route |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function
Patients will be asked to fill out female sexual function index (FSFI) prior to surgery and at the 3-month follow-up.
Measured: Three months
Vaginal length
Vaginal measure will be taken prior to surgery and at 1-month follow-up.
Measured: One months
Secondary outcomes (2)
Vaginal cuff granulation/infection
Vaginal cuff granulation and any evidence of vaginal cuff infection will be carefully examined and documented during the 4-week follow-up visit
Measured: One month
Vaginal cuff closure time
Cuff closure time will be recorded for each patient during the surgery.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey
- Responsible party
- Principal investigator, Ercan Bastu, Istanbul University
- Investigators
- Faruk Buyru, M.D., Study chair, Istanbul University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293369
- Sponsor's protocol ID
- 1424
- Status last verified
- Jan 2016
- First submitted
- 13 Nov 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy and Their Effect on Female Sexual Function and Vaginal Length
- ClinicalTrials.gov ID
- NCT02293369
- Acronym / sponsor ID
- 1424
- Conditions
- Total Laparoscopic Hysterectomy, Benign Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- University of Surrey
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Nov 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.
American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs.
Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.
Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuff closure via vaginal route | Active comparator | Procedure: Cuff closure via vaginal routeFor vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite and will continue toward the surgeon until the other uterosacral ligament will be incorporated into the repair, using a continuous 0-Vicryl suture in the vaginal route. |
| Cuff closure via laparoscopic route | Active comparator | Procedure: Cuff closure via laparoscopic routeFor vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. In the laparoscopic approach, needles will be introduced through the umbilical trocar and removed through the peripheral trocars and intracorporeal knots will be utilized. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only
Key exclusion criteria (2 listed)
- Suspicion of malignancy
- Presence of large adnexal masses (maximum diameter >10 cm at preoperative ultrasonography)
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 |
|---|---|---|
| Cuff closure via vaginal routeVaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy. | Procedure or surgery | Cuff closure via vaginal route |
| Cuff closure via laparoscopic routeVaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy. | Procedure or surgery | Cuff closure via laparoscopic route |
Primary outcome
Female Sexual Function
Time frame: Three months
Patients will be asked to fill out female sexual function index (FSFI) prior to surgery and at the 3-month follow-up.
Vaginal length
Time frame: One months
Vaginal measure will be taken prior to surgery and at 1-month follow-up.
2 secondary outcomes
Vaginal cuff granulation/infection
Time frame: One month
Vaginal cuff closure time
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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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.
Faruk Buyru, M.D. study chair
Istanbul University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cuff closure via vaginal route and Cuff closure via laparoscopic route in people with Total Laparoscopic Hysterectomy and Benign Conditions, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 8 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function (time frame: Three months). The study lists 2 primary outcomes in all. 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 8 Jan 2016.