Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE) Hysterectomy

Not Applicable

Completed

• Conditions: Deep Infiltrating Endometriosis (DIE); Nerve Sparing Modified Radical Hysterectomy; Uterine Skeletonization

• Registration Number: NCT06802900
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2024-09-17
• Study Completion: 2024-09-17
• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
1.Surgical features of the Modified Radical Hysterectomy for DIE with Uterine Sketelonization	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	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	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 Outcome Measures

Name	Time	Method
Postoperative complications	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.

Trial Locations

Locations (1)

Basaksehir Cam ve Sakura City Hospital; 🇹🇷 Istanbul, Turkey