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Completed

NCT Number: NCT06802900

Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE) Hysterectomy

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.

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Key information

Conditions

Deep Infiltrating Endometriosis (DIE) Nerve Sparing Modified Radical Hysterectomy Uterine Skeletonization

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Basaksehir Cam ve Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Secondary outcomes

  1. Postoperative complications

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

Other outcomes

  1. Age of the patients

    Time frame: From enrollment to the end of treatment at 8 weeks

    Patients' age in years will be collected.

  2. Patients' weight

    Time frame: From enrollment to the end of treatment at 8 weeks

    Patients' weight in kilograms will be collected.

  3. Patients' height

    Time frame: From enrollment to the end of treatment at 8 weeks

    Patients' height will be stated as meters obtained from medical records.

  4. Patients' BMI

    Time frame: From enrollment to the end of treatment at 8 weeks

    Body mass index of the patients will be calculated by weight (kg) and height (meter) will be combined to report BMI in kg/m^2

  5. Patients' Medical History

    Time frame: From enrollment to the end of treatment at 8 weeks

    Known comorbidities, mode and number of deliveries, and previous surgeries will be collected, along with preoperative medical treatments from medical records .

  6. Preoperative Imaging

    Time frame: From enrollment to the end of treatment at 8 weeks

    Preoperative imaging findings, including ultrasonography, computed tomography (CT), and Magnetic Resonance Imaging (MRI) reports, will be reviewed.

  7. Visual analog scale (VAS) scores

    Time frame: From enrollment to the end of treatment at 12 weeks

    Visual analog scale (VAS) scores for dysmenorrhea, dyspareunia, dysuria, dyschezia, and chronic pelvic pain before and after the surgery will be obtained from the hospital records and patient files.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Assessment of Surgical Techniques and Clinical Outcomes in Patients Undergoing Nerve-Sparing Modified Radical Hysterectomy With Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE)"

Acronym: SKELETONDIE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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