Pelvic Organ ProlapseNCT03753516
Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques
A study testing Laparoscopic - Vaginal Cuff Closure and Vaginal- Vaginal Cuff Closure in people with Pelvic Organ Prolapse, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Laparoscopic - Vaginal Cuff Closure and Vaginal- Vaginal Cuff Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Dec 2020
- 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
- Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease.
- Subjects must be able to self-consent.
- Department of Defense beneficiary
Who cannot join
- Patients will be excluded if they undergo a concurrent procedure for prolapse.
- If the indication for the procedure is a malignancy.
- Those that plan to leave the area in less than 1 year will not be included.
- Pop-Q Point C of >-4
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Laparoscopic - Vaginal Cuff Closure, Vaginal- Vaginal Cuff Closure
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic - Vaginal Cuff ClosureProcedure or surgery
All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.
Vaginal- Vaginal Cuff ClosureProcedure or surgery
All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic - Vaginal Cuff Closure | Active comparator | Not described Receives: Procedure: Laparoscopic - Vaginal Cuff Closure |
| Vaginal - Vaginal Cuff Closure | Active comparator | Not described Receives: Procedure: Vaginal- Vaginal Cuff Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse - Quantification Point C
The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 6-8 weeks to see if prolapse is better using one method vs the other.
Measured: 6-8 weeks post op
Pelvic Organ Prolapse - Quantification Point C
The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 1 year to see if prolapse is better using one method vs the other.
Measured: 1 year post op
Secondary outcomes (4)
Vaginal Cuff Dehiscence
Measured: 1 year
Vaginal Cuff Abscess
Measured: 1 year
Vaginal Cuff Cellulitis
Measured: 1 year
Vaginal Cuff bleeding
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Jul 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Why it stopped: Difficulty with follow up 2/2 COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753516
- Sponsor's protocol ID
- WRNMMC-2017-0055
- Status last verified
- Oct 2024
- First submitted
- 20 Nov 2018
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques
- ClinicalTrials.gov ID
- NCT03753516
- Acronym / sponsor ID
- WRNMMC-2017-0055
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with follow up 2/2 COVID-19 Pandemic
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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 purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic - Vaginal Cuff Closure | Active comparator | Procedure: Laparoscopic - Vaginal Cuff Closure |
| Vaginal - Vaginal Cuff Closure | Active comparator | Procedure: Vaginal- Vaginal Cuff Closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease.
- Subjects must be able to self-consent.
- Department of Defense beneficiary
Key exclusion criteria (4 listed)
- Patients will be excluded if they undergo a concurrent procedure for prolapse.
- If the indication for the procedure is a malignancy.
- Those that plan to leave the area in less than 1 year will not be included.
- Pop-Q Point C of >-4
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 |
|---|---|---|
| Laparoscopic - Vaginal Cuff ClosureAll participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture. | Procedure or surgery | Laparoscopic - Vaginal Cuff Closure |
| Vaginal- Vaginal Cuff ClosureAll participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion. | Procedure or surgery | Vaginal - Vaginal Cuff Closure |
Primary outcome
Pelvic Organ Prolapse - Quantification Point C
Time frame: 6-8 weeks post op
The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 6-8 weeks to see if prolapse is better using one method vs the other.
Pelvic Organ Prolapse - Quantification Point C
Time frame: 1 year post op
The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 1 year to see if prolapse is better using one method vs the other.
4 secondary outcomes
Vaginal Cuff Dehiscence
Time frame: 1 year
Vaginal Cuff Abscess
Time frame: 1 year
Vaginal Cuff Cellulitis
Time frame: 1 year
Vaginal Cuff bleeding
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficulty with follow up 2/2 COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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 Laparoscopic - Vaginal Cuff Closure and Vaginal- Vaginal Cuff Closure in people with Pelvic Organ Prolapse, run by Walter Reed National Military Medical Center 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Oct 2024. 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 was stopped early (reason given: Difficulty with follow up 2/2 COVID-19 Pandemic). Results are not available in the source record.
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?
Pelvic Organ Prolapse - Quantification Point C (time frame: 6-8 weeks post op). 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 15 Oct 2024.