HysterectomyNCT02276261
The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy
A study testing Vaginal cuff closure - vertical and Vaginal cuff closure - horizontal in people with Hysterectomy, run by Bridgeport Hospital at 1 site in United States.
Trial summary
This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Vaginal cuff closure - vertical and Vaginal cuff closure - horizontal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy
- Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital
- Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital
- Age 18 or older
- Able to give informed consent to participate in the research study
Who cannot join
- Age less than 18
- Unable to give informed consent
- Patients undergoing radical hysterectomy
- Patients receiving vaginal cuff radiation within the study period
- Patients undergoing concomitant pelvic floor or vaginal suspension procedure
Trial locations and contacts
1 site in 1 country.
About this study
This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.
- Conditions
- Hysterectomy
- Being tested
- Vaginal cuff closure - vertical, Vaginal cuff closure - horizontal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal cuff closure - verticalProcedure or surgery
Vaginal cuff is closed vertically.
Vaginal cuff closure - horizontalProcedure or surgery
Vaginal cuff is closed horizontally.
| Study group | Role | What they receive |
|---|---|---|
| Vertical | Experimental | Vaginal cuff closure performed in a vertical manner. Receives: Procedure: Vaginal cuff closure - vertical |
| Horizontal | Active comparator | Vaginal cuff closure performed in a horizontal manner. Receives: Procedure: Vaginal cuff closure - horizontal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal length
Vaginal length will be measured in cm by standard POP-Q measurements
Measured: 1-3 weeks postop
Secondary outcomes (2)
Vaginal length
Vaginal length will be measured in cm by standard POP-Q measurements
Measured: 3-4 months postop
Cuff closure time
Time will be recorded by the circulating nurse in seconds
Measured: intra-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridgeport Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Tower, Bridgeport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276261
- Sponsor's protocol ID
- 111401
- Status last verified
- Jul 2016
- First submitted
- 20 Oct 2014
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT02276261
- Acronym / sponsor ID
- 111401
- Conditions
- Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bridgeport HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Oct 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.
This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertical | Experimental | Procedure: Vaginal cuff closure - verticalVaginal cuff closure performed in a vertical manner. |
| Horizontal | Active comparator | Procedure: Vaginal cuff closure - horizontalVaginal cuff closure performed in a horizontal manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy
- Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital
- Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital
- Age 18 or older
- Able to give informed consent to participate in the research study
Key exclusion criteria (5 listed)
- Age less than 18
- Unable to give informed consent
- Patients undergoing radical hysterectomy
- Patients receiving vaginal cuff radiation within the study period
- Patients undergoing concomitant pelvic floor or vaginal suspension procedure
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 |
|---|---|---|
| Vaginal cuff closure - verticalVaginal cuff is closed vertically. | Procedure or surgery | Vertical |
| Vaginal cuff closure - horizontalVaginal cuff is closed horizontally. | Procedure or surgery | Horizontal |
Primary outcome
Vaginal length
Time frame: 1-3 weeks postop
Vaginal length will be measured in cm by standard POP-Q measurements
2 secondary outcomes
Vaginal length
Time frame: 3-4 months postop
Cuff closure time
Time frame: intra-op
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 20 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal cuff closure - vertical and Vaginal cuff closure - horizontal in people with Hysterectomy, run by Bridgeport Hospital at 1 site in United States.
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 5 inclusion and 5 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 20 Jul 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 United States. 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?
Vaginal length (time frame: 1-3 weeks postop). 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 20 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.