Uterine Skeletonization for Deep Infiltrative Endometriosis (DIE) Hysterectomy

NCT06802900 | Completed

• 1 other identifier: E-96317027-514.10-253796352
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Deep Infiltrating Endometriosis (DIE); Nerve sparing modified radical hysterectomy; Uterine skeletonization

Outcome Measures

Primary Outcomes (3)

• 1.Surgical features of the Modified Radical Hysterectomy for DIE with Uterine Sketelonization

  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)

  From placing the laparoscopic trocars to the end of the surgery

• Duration of operation

  Duration of the laparascopic deep infiltrating hysterectomy with uterine skeletonization will be stated which was recorded as minute.

  From placing the laparoscopic trocars to the end of the surgery

• Intraoperative complications

  Complications during surgery for deep infiltrating surgery such as bladder, ureter, bowel and nerve injuries will be reviewed.

  From placing the laparoscopic trocars to the end of the surgery

Secondary Outcomes (1)

• Postoperative complications

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (7)

• Age of the patients

  From enrollment to the end of treatment at 8 weeks

• Patients' weight

  From enrollment to the end of treatment at 8 weeks

• Patients' height

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

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

OTHER

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.

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

Interventions

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.

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

Eligibility Criteria

• Age: 30 Years - 55 Years
• Gender Eligibility Details: endometriosis is a disease of biologically female gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32963921 BACKGROUND

• 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.

  PMID: 35781108 BACKGROUND

• 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.

  PMID: 31326949 BACKGROUND

• 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.

  PMID: 27951614 BACKGROUND

Study Officials

• Baris Kaya, Associate Professor

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Retrospective analysis of the prospectively collected data of the surgical technique, intraoperative and postoperative clinical outcomes and complications

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 31, 2025
• Study Start: October 1, 2022
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)