Clinical trial NCT06802900: Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE) Hysterectomy
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)"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Infiltrating Endometriosis (DIE)
Nerve Sparing Modified Radical Hysterectomy
Uterine Skeletonization
Keywords: Deep Infiltrating Endometriosis (DIE)
Nerve sparing modified radical hysterectomy
Uterine skeletonization
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-31
Enrollment: 75
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Retrospective analysis of the prospectively collected data of the surgical technique, intraoperative and postoperative clinical outcomes and complications
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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.

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Primary outcomes:
measure: 1.Surgical features of the Modified Radical Hysterectomy for DIE with Uterine Sketelonization
timeFrame: From placing the laparoscopic trocars to the end of the surgery
measure: Duration of operation
timeFrame: From placing the laparoscopic trocars to the end of the surgery
measure: Intraoperative complications
timeFrame: From placing the laparoscopic trocars to the end of the surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
measure: Age of the patients
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Patients' weight
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Patients' height
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Patients' BMI
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Patients' Medical History
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Preoperative Imaging
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Visual analog scale (VAS) scores
timeFrame: From enrollment to the end of treatment at 12 weeks
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura City Hospital
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Baris Kaya, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rosati 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.
citation: Muallem 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.
citation: Darwish 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.