Deep Infiltrating Endometriosis (DIE)SKELETONDIENCT06802900
Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE) Hysterectomy
A study testing Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis in people with Deep Infiltrating Endometriosis (DIE) and Nerve Sparing Modified Radical Hysterectomy, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Endometriosis is characterized by the presence of endometrial glands and stroma outside the uterine cavity, accompanied by chronic inflammation. The most common locations of endometriosis are the ovaries, ovarian fossae, uterosacral ligaments, and the posterior cul-de-sac. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Deep Infiltrating Endometriosis (DIE), Nerve Sparing Modified Radical Hysterectomy, Uterine Skeletonization
- What is being tested?
- Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 17 Sep 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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients Aged 30-50
- Patients with severe dysmenorrhea (VAS>7) dyspareunia (VAS>7), and /or diskhezia and/or chronic pelvic pain
- Patients with deep infiltrating endometriosis who are unresponsive to medical treatment
- Only patients who underwent nerve sparing hysterectomy by the principal investigator (BK)
Who cannot join
- Patients under 30 or over 50 years of age. Patients who did not undergo nerve-sparing hysterectomy or salpingo-oophorectomy.
- Patients with incomplete medical records or missing preoperative imaging data. Patients with a history of pelvic or abdominal malignancy. Patients with significant comorbidities such as advanced cardiovascular or respiratory diseases that may affect surgical outcomes.
- Patients who responded positively to medical treatment and did not require surgical intervention.
- Patients diagnosed with bowel, bladder, or rectovaginal fistulas unrelated to endometriosis.
- Patients undergoing emergency surgeries unrelated to endometriosis. Patients unwilling to provide consent for their data to be used in the study.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura City Hospital
Istanbul, 34480
About this study
Official title: Assessment of Surgical Techniques and Clinical Outcomes in Patients Undergoing Nerve-Sparing Modified Radical Hysterectomy With Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE)"
Endometriosis is characterized by the presence of endometrial glands and stroma outside the uterine cavity, accompanied by chronic inflammation. The most common locations of endometriosis are the ovaries, ovarian fossae, uterosacral ligaments, and the posterior cul-de-sac. Endometriosis lesions may be superficial, ovarian, or deeply infiltrative. Lesions that invade the rectovaginal space and/or the bowel are defined as deep infiltrative endometriosis (DIE). The invasive nature of these implants can lead to infertility, severe menstrual pain (dysmenorrhea), pain during intercourse (dyspareunia), and chronic pelvic pain. In cases of bowel involvement, symptoms such as constipation, painful defecation, and rectal bleeding may occur. When the urinary system is affected, patients may experience painful urination, hematuria, urinary dysfunction, and, in severe cases, renal loss due to ureteral obstruction.Treatment options vary depending on the severity and localization of the disease, the patient's desire for fertility, and their age. Treatment can include medical therapy, surgical therapy, or a combination of both. Surgical approaches to DIE can be conservative or definitive. Conservative surgery involves the removal of symptomatic endometriotic lesions without damaging surrounding structures. Definitive surgery typically includes hysterectomy with bilateral salpingo-oophorectomy and the excision of symptomatic lesions in other areas (e.g., peritoneum, bowel), often described as a radical hysterectomy. Here in this study, the hospital records of the patients who underwent modified radical nerve sapring hysterectomy for deeply infiltrating endometriosis by the gynecologist Baris Kaya,MD will be evaluated. The demographic and clinical characteristics of patients who underwent hysterectomy for endometriosis at our hospital's endometriosis clinic will be retrospectively analyzed. The diagnosis of these patients was already established through routine pelvic examination, transvaginal ultrasonography, and MRI at the endometriosis clinic of Basaksehir Cam ve Sakura City Hospital.
Read the detailed description
The aim of this study is to contribute to the literature by evaluating the surgical features, intraoperative complications, and postoperative outcomes of patients undergoing nerve-sparing hysterectomy due to endometriosis. Steps of the modified radical hysterectomy for deeply infiltrating endometriosis with uterine skeletonization technique will be clearly stated, Data on patients' age, body mass index (BMI), known comorbidities, mode and number of deliveries, and previous surgeries will be collected, along with preoperative medical treatments. Visual analog scale (VAS) scores for dysmenorrhea, dyspareunia, dysuria, dyschezia, and chronic pelvic pain will be obtained from the HBYS system or patient files. Preoperative imaging findings, including ultrasonography, computed tomography (CT), and MRI, will be reviewed. Surgical data such as operation duration, surgical type (e.g., hysterectomy + salpingo-oophorectomy, excision of parametrial, rectovaginal, or vaginal nodules, and bowel resections), and intraoperative complications (organ injuries, blood transfusions, conversion to open surgery) will be recorded. ENZIAN scores according to the surgical findings will be stated. Early and late postoperative complications (fever, deep vein thrombosis, sepsis, pelvic abscess, genitourinary fistulas, anastomotic leaks, reoperation, vaginal cuff bleeding or abscess, and bladder dysfunction) will also be evaluated according to Clavien-Dindo Clasification. Pathological examination results of the excised specimens will be included.
- Conditions
- Deep Infiltrating Endometriosis (DIE), Nerve Sparing Modified Radical Hysterectomy, Uterine Skeletonization
- Being tested
- Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis
- Keywords
- Deep Infiltrating Endometriosis (DIE), Nerve sparing modified radical hysterectomy, Uterine skeletonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative EndometriosisProcedure or surgery
In this retrospective study, the patents whom underwent nerve sparing modified radical hysterectomy for deeply infiltrating endometriosis with uterine skeletonization technique will be reviewed. The uterine skeletonization technique was developed by the princible investigator (BK) for DIE modified radical hsyterectomy and performed systematically in Basaksehir Cam ve Sakura City Hospital. The detailed surgical steps, surgical data such as operation duration, surgical type (e.g., hysterectomy + salpingo-oophorectomy, excision of parametrial, rectovaginal, or vaginal nodules, and bowel resections), and intraoperative complications (organ injuries, blood transfusions, conversion to open surgery) will be recorded. Early and late postoperative complications (fever, deep vein thrombosis, sepsis, pelvic abscess, genitourinary fistulas, anastomotic leaks, reoperation, vaginal cuff bleeding or abscess, and bladder dysfunction) will also be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| "Evaluation of Uterine Skeletonization-Based Nerve-Sparing Modified Radical Hysterectomy in Deep Inf | Other | Data on patients' demographics, preoperative treatments, imaging findings (ultrasound, CT, MRI), and surgical details (duration, type, complications) will be collected. Postoperative complications and pathological results of excised specimens will also be evaluated. Receives: Procedure: Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Surgical features of the Modified Radical Hysterectomy for DIE with Uterine Sketelonization
Surgical data such as detailed anatomical surgical steps of the surgery, surgery type (e.g., hysterectomy + salpingo-oophorectomy, excision of parametrial, rectovaginal, or vaginal nodules, and bowel resections)
Measured: From placing the laparoscopic trocars to the end of the surgery
Duration of operation
Duration of the laparascopic deep infiltrating hysterectomy with uterine skeletonization will be stated which was recorded as minute.
Measured: From placing the laparoscopic trocars to the end of the surgery
Intraoperative complications
Complications during surgery for deep infiltrating surgery such as bladder, ureter, bowel and nerve injuries will be reviewed.
Measured: From placing the laparoscopic trocars to the end of the surgery
Secondary outcomes (1)
Postoperative complications
Postoperative complications following surgery of the deep infiltrative endometriosis hysterectomy.
Surgical site infections (SSI), urinary tract infections, or pelvic abscesses. Urogenital or rectovaginal fistulas following surgery. Vaginal Cuff Dehiscence, thromboembolic Events, Bladder or bowel dysfunction due to hypogastric and/or pelvic splanchnic nerve damages. These will also be stated as Clavien Dindo classification.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Oct 2022
- Primary completion17 Sep 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Deep Infiltrating Endometriosis (DIE)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective analysis of the prospectively collected data of the surgical technique, intraoperative and postoperative clinical outcomes and complications
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Baris KAYA, Başakşehir Çam & Sakura City Hospital
- Investigators
- Baris Kaya, Associate Professor, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802900
- Sponsor's protocol ID
- E-96317027-514.10-253796352
- Other IDs
- E-96317027-514.10-253796352
- Acronym
- SKELETONDIE
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual Participant Data (IPD) will not be shared due to privacy and confidentiality concerns. Additionally, resource limitations prevent proper preparation and documentation of IPD for external sharing."
Publications
Nezhat C, Nguyen K, Ackroyd E, Roman RA, Rambhatla A, Nezhat A, Asiaii A. Nerve-Sparing Modified Radical Hysterectomy for Severe Endometriosis and Complex Pelvic Pathology. Cureus. 2020 Aug 19;12(8):e9882. doi: 10.7759/cureus.9882.
PubMed 32963921Rosati A, Pavone M, Campolo F, De Cicco Nardone A, Raimondo D, Serracchioli R, Scambia G, Ianieri MM. Surgical and functional impact of nerve-sparing radical hysterectomy for parametrial deep endometriosis: a single centre experience. Facts Views Vis Obgyn. 2022 Jun;14(2):121-127. doi: 10.52054/FVVO.14.2.016.
PubMed 35781108Muallem MZ, Diab Y, Sehouli J, Fujii S. Nerve-sparing radical hysterectomy: steps to standardize surgical technique. Int J Gynecol Cancer. 2019 Sep;29(7):1203-1208. doi: 10.1136/ijgc-2019-000410. Epub 2019 Jul 19.
PubMed 31326949Darwish B, Roman H. Nerve Sparing and Surgery for Deep Infiltrating Endometriosis: Pessimism of the Intellect or Optimism of the Will. Semin Reprod Med. 2017 Jan;35(1):72-80. doi: 10.1055/s-0036-1597305. Epub 2016 Dec 12.
PubMed 27951614
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Surgical Techniques and Clinical Outcomes in Patients Undergoing Nerve-Sparing Modified Radical Hysterectomy With Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE)"
- ClinicalTrials.gov ID
- NCT06802900
- Acronym / sponsor ID
- SKELETONDIE / E-96317027-514.10-253796352
- Conditions
- Deep Infiltrating Endometriosis (DIE), Nerve Sparing Modified Radical Hysterectomy, Uterine Skeletonization
- Keywords
- Deep Infiltrating Endometriosis (DIE), Nerve sparing modified radical hysterectomy, Uterine skeletonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 31 Jan 2025 (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.
Endometriosis is characterized by the presence of endometrial glands and stroma outside the uterine cavity, accompanied by chronic inflammation. The most common locations of endometriosis are the ovaries, ovarian fossae, uterosacral ligaments, and the posterior cul-de-sac. Endometriosis lesions may be superficial, ovarian, or deeply infiltrative. Lesions that invade the rectovaginal space and/or the bowel are defined as deep infiltrative endometriosis (DIE). The invasive nature of these implants can lead to infertility, severe menstrual pain (dysmenorrhea), pain during intercourse (dyspareunia), and chronic pelvic pain. In cases of bowel involvement, symptoms such as constipation, painful defecation, and rectal bleeding may occur. When the urinary system is affected, patients may experience painful urination, hematuria, urinary dysfunction, and, in severe cases, renal loss due to ureteral obstruction.Treatment options vary depending on the severity and localization of the disease, the patient's desire for fertility, and their age. Treatment can include medical therapy, surgical therapy, or a combination of both. Surgical approaches to DIE can be conservative or definitive. Conservative surgery involves the removal of symptomatic endometriotic lesions without damaging surrounding structures. Definitive surgery typically includes hysterectomy with bilateral salpingo-oophorectomy and the excision of symptomatic lesions in other areas (e.g., peritoneum, bowel), often described as a radical hysterectomy. Here in this study, the hospital records of the patients who underwent modified radical nerve sapring hysterectomy for deeply infiltrating endometriosis by the gynecologist Baris Kaya,MD will be evaluated. The demographic and clinical characteristics of patients who underwent hysterectomy for endometriosis at our hospital's endometriosis clinic will be retrospectively analyzed. The diagnosis of these patients was already established through routine pelvic examination, transvaginal ultrasonography, and MRI at the endometriosis clinic of Basaksehir Cam ve Sakura City Hospital.
Detailed description
The aim of this study is to contribute to the literature by evaluating the surgical features, intraoperative complications, and postoperative outcomes of patients undergoing nerve-sparing hysterectomy due to endometriosis. Steps of the modified radical hysterectomy for deeply infiltrating endometriosis with uterine skeletonization technique will be clearly stated, Data on patients' age, body mass index (BMI), known comorbidities, mode and number of deliveries, and previous surgeries will be collected, along with preoperative medical treatments. Visual analog scale (VAS) scores for dysmenorrhea, dyspareunia, dysuria, dyschezia, and chronic pelvic pain will be obtained from the HBYS system or patient files. Preoperative imaging findings, including ultrasonography, computed tomography (CT), and MRI, will be reviewed. Surgical data such as operation duration, surgical type (e.g., hysterectomy + salpingo-oophorectomy, excision of parametrial, rectovaginal, or vaginal nodules, and bowel resections), and intraoperative complications (organ injuries, blood transfusions, conversion to open surgery) will be recorded. ENZIAN scores according to the surgical findings will be stated. Early and late postoperative complications (fever, deep vein thrombosis, sepsis, pelvic abscess, genitourinary fistulas, anastomotic leaks, reoperation, vaginal cuff bleeding or abscess, and bladder dysfunction) will also be evaluated according to Clavien-Dindo Clasification. Pathological examination results of the excised specimens will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective analysis of the prospectively collected data of the surgical technique, intraoperative and postoperative clinical outcomes and complications
| Arm | Type | Receives |
|---|---|---|
| "Evaluation of Uterine Skeletonization-Based Nerve-Sparing Modified Radical Hysterectomy in Deep Inf | Other | Procedure: Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative EndometriosisData on patients' demographics, preoperative treatments, imaging findings (ultrasound, CT, MRI), and surgical details (duration, type, complications) will be collected. Postoperative complications and pathological results of excised specimens will also be evaluated. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients Aged 30-50
- Patients with severe dysmenorrhea (VAS>7) dyspareunia (VAS>7), and /or diskhezia and/or chronic pelvic pain
- Patients with deep infiltrating endometriosis who are unresponsive to medical treatment
- Only patients who underwent nerve sparing hysterectomy by the principal investigator (BK)
Key exclusion criteria (6 listed)
- Patients under 30 or over 50 years of age. Patients who did not undergo nerve-sparing hysterectomy or salpingo-oophorectomy.
- Patients with incomplete medical records or missing preoperative imaging data. Patients with a history of pelvic or abdominal malignancy. Patients with significant comorbidities such as advanced cardiovascular or respiratory diseases that may affect surgical outcomes.
- Patients who responded positively to medical treatment and did not require surgical intervention.
- Patients diagnosed with bowel, bladder, or rectovaginal fistulas unrelated to endometriosis.
- Patients undergoing emergency surgeries unrelated to endometriosis. Patients unwilling to provide consent for their data to be used in the study.
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 |
|---|---|---|
| Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative EndometriosisIn this retrospective study, the patents whom underwent nerve sparing modified radical hysterectomy for deeply infiltrating endometriosis with uterine skeletonization technique will be reviewed. The uterine skeletonization technique was developed by the princible investigator (BK) for DIE modified radical hsyterectomy and performed systematically in Basaksehir Cam ve Sakura City Hospital. The detailed surgical steps, surgical data such as operation duration, surgical type (e.g., hysterectomy + salpingo-oophorectomy, excision of parametrial, rectovaginal, or vaginal nodules, and bowel resections), and intraoperative complications (organ injuries, blood transfusions, conversion to open surgery) will be recorded. Early and late postoperative complications (fever, deep vein thrombosis, sepsis, pelvic abscess, genitourinary fistulas, anastomotic leaks, reoperation, vaginal cuff bleeding or abscess, and bladder dysfunction) will also be evaluated. | Procedure or surgery | "Evaluation of Uterine Skeletonization-Based Nerve-Sparing Modified Radical Hysterectomy in Deep Inf |
Primary outcome
1.Surgical features of the Modified Radical Hysterectomy for DIE with Uterine Sketelonization
Time frame: From placing the laparoscopic trocars to the end of the surgery
Surgical data such as detailed anatomical surgical steps of the surgery, surgery type (e.g., hysterectomy + salpingo-oophorectomy, excision of parametrial, rectovaginal, or vaginal nodules, and bowel resections)
Duration of operation
Time frame: From placing the laparoscopic trocars to the end of the surgery
Duration of the laparascopic deep infiltrating hysterectomy with uterine skeletonization will be stated which was recorded as minute.
Intraoperative complications
Time frame: From placing the laparoscopic trocars to the end of the surgery
Complications during surgery for deep infiltrating surgery such as bladder, ureter, bowel and nerve injuries will be reviewed.
1 secondary outcome
Postoperative complications
Time frame: From enrollment to the end of treatment at 12 weeks
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 31 Jan 2025.
- Results publication: PubMed 32963921Nezhat C, Nguyen K, Ackroyd E, Roman RA, Rambhatla A, Nezhat A, Asiaii A. Nerve-Sparing Modified Radical Hysterectomy for Severe Endometriosis and Complex Pelvic Pathology. Cureus. 2020 Aug 19;12(8):e9882. doi: 10.7759/cureus.9882.
- Results publication: PubMed 35781108Rosati A, Pavone M, Campolo F, De Cicco Nardone A, Raimondo D, Serracchioli R, Scambia G, Ianieri MM. Surgical and functional impact of nerve-sparing radical hysterectomy for parametrial deep endometriosis: a single centre experience. Facts Views Vis Obgyn. 2022 Jun;14(2):121-127. doi: 10.52054/FVVO.14.2.016.
- Results publication: PubMed 31326949Muallem MZ, Diab Y, Sehouli J, Fujii S. Nerve-sparing radical hysterectomy: steps to standardize surgical technique. Int J Gynecol Cancer. 2019 Sep;29(7):1203-1208. doi: 10.1136/ijgc-2019-000410. Epub 2019 Jul 19.
- Results publication: PubMed 27951614Darwish B, Roman H. Nerve Sparing and Surgery for Deep Infiltrating Endometriosis: Pessimism of the Intellect or Optimism of the Will. Semin Reprod Med. 2017 Jan;35(1):72-80. doi: 10.1055/s-0036-1597305. Epub 2016 Dec 12.
- Individual participant dataSharing planned: No. "Individual Participant Data (IPD) will not be shared due to privacy and confidentiality concerns. Additionally, resource limitations prevent proper preparation and documentation of IPD for external sharing."
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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.
Baris Kaya, Associate Professor principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis in people with Deep Infiltrating Endometriosis (DIE) and Nerve Sparing Modified Radical Hysterectomy, run by Başakşehir Çam & Sakura City 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 4 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 31 Jan 2025. 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?
1.Surgical features of the Modified Radical Hysterectomy for DIE with Uterine Sketelonization (time frame: From placing the laparoscopic trocars to the end of the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802900, which also lists 4 linked publications.
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 31 Jan 2025.