Endometrial CancerNCT04240730
Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer
An observational study of Endometrial Cancer and Extreme Obesity, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer, Extreme Obesity
- What is being tested?
- Transvaginal natural orifice endoscopic surgery for endometrial cancer staging
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Jun 2019
- Phase
- Observational
- 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
Study population: Extreme obese patients with early stage type-1 endometrial cancer
Who may be able to join
- Extreme obese patients
- Early stage type-1 endometrial cancer proved by endometrial sampling
Who cannot join
- any contraindication for pneumoperitoneum
- any contraindication for the dorsal lithotomy position
- any contraindication for general anesthesia,
- any contraindication for v-NOTES
- suspicion of pelvic adhesions
- presence or suspicion of obliteration of the pouch of Douglas
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kartal Dr. Lütfi Kirdar Training and Research Hospital
Istanbul, Kartal, 34890
About this study
Official title: Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
The aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer.
- Conditions
- Endometrial Cancer, Extreme Obesity
- Being tested
- Transvaginal natural orifice endoscopic surgery for endometrial cancer staging
- Keywords
- Early stage endometrial cancer, extreme obesity, transvaginal NOTES
- Medical subject headings
- Endometrial Neoplasms, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal natural orifice endoscopic surgery for endometrial cancer stagingProcedure or surgery
Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES
| Study group | Role | What they receive |
|---|---|---|
| extremely obese patients with early-stage endometrial cancer | Not described Receives: Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time
The operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure.
Measured: 4 hours
Any conversion to conventional laparoscopy or laparotomy
Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.
Measured: 4 hours
Pre- and post-operative hemoglobin levels
Hemoglobin levels in g/dL. Hemoglobin levels of the patients before surgery and on postoperative day 1.
Measured: 24 hours
Length of hospital stay
Length of hospital stay in days. Duration of hospital stay was calculated from the patient's admission until hospital discharge.
Measured: 2 day
Any intra- or post-operative complication
Number of the patients who have any complication during or after transvaginal natural orifice surgery.
Measured: 6 months
pain scores
Pain scores in VAS score. Pain scores were evaluated using a visual analog scale (VAS). Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Measured: 6 hours
pain scores
Pain scores in VAS score. Pain scores were evaluated using a visual analog scale (VAS). Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Measured: 12 hours
pain scores
Pain scores in VAS score. Pain scores were evaluated using a visual analog scale (VAS). Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emre Mat, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Ahmet Kale, Prof.Dr., Study director, Kartal Dr.Lutfi Kirdar Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240730
- Sponsor's protocol ID
- v-NOTESandobesity
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Natural Orifice Endoscopic Surgery (v-NOTES) for Extremely Obese Patients With Early-stage Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04240730
- Acronym / sponsor ID
- v-NOTESandobesity
- Conditions
- Endometrial Cancer, Extreme Obesity
- Keywords
- Early stage endometrial cancer, extreme obesity, transvaginal NOTES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Jan 2020 (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 aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extremely obese patients with early-stage endometrial cancer | – | Procedure: Transvaginal natural orifice endoscopic surgery for endometrial cancer staging |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Extreme obese patients with early stage type-1 endometrial cancer
Key inclusion criteria (2 listed)
- Extreme obese patients
- Early stage type-1 endometrial cancer proved by endometrial sampling
Key exclusion criteria (6 listed)
- any contraindication for pneumoperitoneum
- any contraindication for the dorsal lithotomy position
- any contraindication for general anesthesia,
- any contraindication for v-NOTES
- suspicion of pelvic adhesions
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 |
|---|---|---|
| Transvaginal natural orifice endoscopic surgery for endometrial cancer stagingCases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES | Procedure or surgery | extremely obese patients with early-stage endometrial cancer |
Primary outcome
Operating time
Time frame: 4 hours
The operation time in minutes. The operation time was from commencement of the colpotomy incision to vaginal closure.
Any conversion to conventional laparoscopy or laparotomy
Time frame: 4 hours
Number of the patients whose surgery couldn't completed by transvaginal natural orifice surgery.
Pre- and post-operative hemoglobin levels
Time frame: 24 hours
Hemoglobin levels in g/dL. Hemoglobin levels of the patients before surgery and on postoperative day 1.
Length of hospital stay
Time frame: 2 day
Length of hospital stay in days. Duration of hospital stay was calculated from the patient's admission until hospital discharge.
Any intra- or post-operative complication
Time frame: 6 months
Number of the patients who have any complication during or after transvaginal natural orifice surgery.
pain scores
Time frame: 6 hours
Pain scores in VAS score. Pain scores were evaluated using a visual analog scale (VAS). Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
pain scores
Time frame: 12 hours
Pain scores in VAS score. Pain scores were evaluated using a visual analog scale (VAS). Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
pain scores
Time frame: 24 hours
Pain scores in VAS score. Pain scores were evaluated using a visual analog scale (VAS). Scores are based on self-reported measures of pain that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
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 11 Feb 2020.
- 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.
Ahmet Kale, Prof.Dr. study director
Kartal Dr.Lutfi Kirdar Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Extreme Obesity, 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 2 inclusion and 6 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 11 Feb 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?
Operating time (time frame: 4 hours). The study lists 8 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 11 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.