Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE) Hysterectomy

NCT ID: NCT06802900

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-17

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.

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Evaluation of Uterine Skeletonization-Based Nerve-Sparing Modified Radical Hysterectomy in Deep Inf

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.

Group Type: OTHER

Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis

Intervention Type: PROCEDURE

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.

Interventions

Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis

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.

Intervention Type: PROCEDURE

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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• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Baris KAYA

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baris Kaya, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

Basaksehir Cam ve Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32963921 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35781108 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31326949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27951614 (View on PubMed)

Other Identifiers

E-96317027-514.10-253796352

Identifier Type: OTHER

Identifier Source: secondary_id

E-96317027-514.10-253796352

Identifier Type: -

Identifier Source: org_study_id