NCT06802900: SKELETONDIE

Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE) Hysterectomy

Completed NA Last updated 31 January 2025

What this trial tests

NA trial testing Clinical Outcomes and Surgical Insights from Nerve-Sparing Hysterectomy with Uterine Skeletonization for Deep Infiltrative Endometriosis in Deep Infiltrating Endometriosis (DIE) in 75 participants. Completed in 17 September 2024.

Timeline

1 October 2022

Primary endpoint
17 September 2024

17 September 2024

Quick facts

Lead sponsor	Başakşehir Çam & Sakura City Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	1 October 2022
Primary completion	17 September 2024
Estimated completion	17 September 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

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

Conditions studied

• Deep Infiltrating Endometriosis (DIE) — all drugs for Deep Infiltrating Endometriosis (DIE) →
• Nerve Sparing Modified Radical Hysterectomy — all drugs for Nerve Sparing Modified Radical Hysterectomy →
• Uterine Skeletonization — all drugs for Uterine Skeletonization →

Sponsor

Başakşehir Çam & Sakura City Hospital

Who can join

Adults 30 to 55, female only, with Deep Infiltrating Endometriosis (DIE) or Nerve Sparing Modified Radical Hysterectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Uterine Skeletonization in Modified Radical Hysterectomy for Deep Infiltrative Endometriosis: The SkeletonDIE Study
   Kaya B, Ince A, Ozdemir MS, Yuksel S. · · 2025 · DOI 10.21203/rs.3.rs-7098525/v1