Surgical Wound DehiscenceNCT02879487
Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy
A study testing Monopolar needle electrode in people with Surgical Wound Dehiscence, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Dehiscence
- What is being tested?
- Monopolar needle electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Sep 2017
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All total laparoscopic hysterectomies performed by a single surgeon
- Both benign and malignant cases
- Completed laparoscopically
- Intracorporeal vaginal cuff suturing
Who cannot join
- Robotic hysterectomies
- Pelvic infection within 30 days before surgery
- Conversion to laparotomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical Faculty Hospital
Ankara, 06100
About this study
Official title: Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial
The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.
- Conditions
- Surgical Wound Dehiscence
- Being tested
- Monopolar needle electrode
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar needle electrodeDevice
Colpotomy during total laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Coagulation mode | Active comparator | Colpotomy will be performed by monopolar needle electrode using coagulation mode Receives: Device: Monopolar needle electrode |
| Cut mode | Active comparator | Colpotomy will be performed by monopolar needle electrode using cut mode Receives: Device: Monopolar needle electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal dehiscence
Vaginal dehiscence up to 3 months after surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound DehiscenceStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salih taskin, Ankara University
- Investigators
- Emre Şükür, MD, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879487
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2020
- First submitted
- 19 Aug 2016
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02879487
- Acronym / sponsor ID
- 01
- Conditions
- Surgical Wound Dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Aug 2016 (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 study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coagulation mode | Active comparator | Device: Monopolar needle electrodeColpotomy will be performed by monopolar needle electrode using coagulation mode |
| Cut mode | Active comparator | Device: Monopolar needle electrodeColpotomy will be performed by monopolar needle electrode using cut mode |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All total laparoscopic hysterectomies performed by a single surgeon
- Both benign and malignant cases
- Completed laparoscopically
- Intracorporeal vaginal cuff suturing
Key exclusion criteria (3 listed)
- Robotic hysterectomies
- Pelvic infection within 30 days before surgery
- Conversion to laparotomy
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 |
|---|---|---|
| Monopolar needle electrodeColpotomy during total laparoscopic hysterectomy | Device | Coagulation mode, Cut mode |
Primary outcome
Vaginal dehiscence
Time frame: 3 months
Vaginal dehiscence up to 3 months after surgery
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 21 Sep 2020.
- Individual participant dataSharing planned: Yes
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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.
Emre Şükür, MD study chair
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar needle electrode in people with Surgical Wound Dehiscence, run by Ankara 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 4 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: finished, as of the sponsor's last update on 21 Sep 2020. 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?
Vaginal dehiscence (time frame: 3 months). 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 21 Sep 2020.