Gynecologic DiseaseNCT06374940
Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy
A study testing Manipulator-assisted Abdominal Hysterectomy in people with Gynecologic Disease, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Manipulator-assisted Abdominal Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2024to 18 May 2024
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications
Who cannot join
- Exclusion criteria were patients with additional procedures such as urogynecologic procedures, history of abdominal surgery with midline incision, patients with suspected gynecologic malignancy, endometriosis, tubo-ovarian abscess, pelvic organ prolapse, or those who refused to participate in the study and whose medical records could not be obtained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Surgical Outcomes to Conventional Hysterectomy and Manipulator-assisted Abdominal Hysterectomy
Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy
Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.
Read more
Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.
Primary outcomes: (1) Operation Time.
Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications
- Conditions
- Gynecologic Disease
- Being tested
- Manipulator-assisted Abdominal Hysterectomy
- Keywords
- Hysterectomy, Manipulator-assisted abdominal hysterectomy
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulator-assisted Abdominal HysterectomyProcedure or surgery
Manipulator-assisted Abdominal Hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| conventional abdominal hysterectomy | No intervention | The surgical technique of conventional abdominal hysterectomy was described in the literature. |
| Manipulator-assisted Abdominal Hysterectomy | Other | In manipulator-assisted abdominal hysterectomy tecnique, a uterine manipulator (SecuFix ® , Richard Wolf) was inserted into the cervix. Conventional hysterectomy steps were performed until the vaginal colpotomy incision. A circular colpotomy incision was made directly over the manipulator silicone cup using a monopolar cautery set at 30W cutting mode without interfering with the cardinal ligament or sacrouterine ligament. The vaginal cuff was sutured using polyglactin 910 (no:1) as a single layer running suture. Receives: Procedure: Manipulator-assisted Abdominal Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the surgical procedure
The surgical operative time was defined as the time from incision to completion of wound closure, also known as 'cut-to-close' time. In the manipulator-assisted abdominal hysterectomy group, the time of uterine manipulator placement was added to the operation time
Measured: intraoperative
Secondary outcomes (4)
Postoperative pain at 6th hours
Postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain.
Measured: At the 6th hours after the surgical procedure
Postoperative pain at 24th hours
postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain.
Measured: At the 24th hours after the surgical procedure
intraoperative complications
Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery
Measured: Intraoperative
Postoperative complications
Any minor and major complications (e.g., bowel injury, haematoma, infection, dyspareunia, vaginal pain, sexual discomfort) that occur in the first month of the surgery.
Measured: Postoperative, in the first month of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start17 Apr 2024
- Primary completion17 May 2024 (estimated)
- Study completion18 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, pınar birol ilter, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374940
- Sponsor's protocol ID
- Lütfi Kırdar City Hospital
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, after the work is published
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Surgical Outcomes to Conventional Hysterectomy and Manipulator-assisted Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT06374940
- Acronym / sponsor ID
- Lütfi Kırdar City Hospital
- Conditions
- Gynecologic Disease
- Keywords
- Hysterectomy, Manipulator-assisted abdominal hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 17 May 2024 (estimated)
- Study completion
- 18 May 2024 (estimated)
- First posted
- 19 Apr 2024 (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.
Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy
Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.
Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.
Primary outcomes: (1) Operation Time.
Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional abdominal hysterectomy | No intervention | –The surgical technique of conventional abdominal hysterectomy was described in the literature. |
| Manipulator-assisted Abdominal Hysterectomy | Other | Procedure: Manipulator-assisted Abdominal HysterectomyIn manipulator-assisted abdominal hysterectomy tecnique, a uterine manipulator (SecuFix ® , Richard Wolf) was inserted into the cervix. Conventional hysterectomy steps were performed until the vaginal colpotomy incision. A circular colpotomy incision was made directly over the manipulator silicone cup using a monopolar cautery set at 30W cutting mode without interfering with the cardinal ligament or sacrouterine ligament. The vaginal cuff was sutured using polyglactin 910 (no:1) as a single layer running suture. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications
Key exclusion criteria (1 listed)
- Exclusion criteria were patients with additional procedures such as urogynecologic procedures, history of abdominal surgery with midline incision, patients with suspected gynecologic malignancy, endometriosis, tubo-ovarian abscess, pelvic organ prolapse, or those who refused to participate in the study and whose medical records could not be obtained.
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 |
|---|---|---|
| Manipulator-assisted Abdominal HysterectomyManipulator-assisted Abdominal Hysterectomy | Procedure or surgery | Manipulator-assisted Abdominal Hysterectomy |
Primary outcome
Duration of the surgical procedure
Time frame: intraoperative
The surgical operative time was defined as the time from incision to completion of wound closure, also known as 'cut-to-close' time. In the manipulator-assisted abdominal hysterectomy group, the time of uterine manipulator placement was added to the operation time
4 secondary outcomes
Postoperative pain at 6th hours
Time frame: At the 6th hours after the surgical procedure
Postoperative pain at 24th hours
Time frame: At the 24th hours after the surgical procedure
intraoperative complications
Time frame: Intraoperative
Postoperative complications
Time frame: Postoperative, in the first month of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Yes. Upon request, after the work is published
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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 Manipulator-assisted Abdominal Hysterectomy in people with Gynecologic Disease, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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 1 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 19 Apr 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 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?
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?
Duration of the surgical procedure (time frame: intraoperative). 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 19 Apr 2024.