Pelvic Neuro-Angiogenesis in Deep Endometriosis

NCT06286371 | Completed

• 1 other identifier: 2023-13/37
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is observed in one out of every ten women in society, causing endometrial cells to be found outside their normal location in the body and proliferate in other locations, leading to fibrosis in the tissue due to the secretion of various factors from the cells. Additionally, the substances secreted by the cells can cause various other changes in the tissue besides fibrosis. Increased neurogenesis and neovascularization are among the primary changes, which occur as a result of the secretion of substances from the cells. Increased neovascularization, neurogenesis, and fibrosis in the tissue lead to the formation of nodular structures in the pelvic region, resulting in pain development in women. Nodular formations in the pelvic region due to endometriosis are especially observed in the rectovaginal space. Despite being small in size, they can induce increased neovascularization and neurogenesis even in healthy peritoneal tissue due to the microenvironment they create, leading to different clinical symptoms clinically. However, it is not known how far these changes occur around the endometriotic nodule in the presence of endometriosis. In this project, in patients operated on due to endometriosis, the density of nerve and vascular structures in the surgical margins of the peritoneal tissue excised along with the nodule, and the synthesis and release of chemical mediators causing pain (e.g., Bradykinin, Substance-P) are evaluated. The aim is to determine the minimum surgical margin where excision should be applied in surgery and to demonstrate any endometriotic changes that may exist in the tissues, even though they may appear macroscopically healthy.

Conditions

Endometriosis-related Pain; Endometriosis; Deep Endometriosis; Endometriosis; Peritoneum

Keywords

Endometriosis; Deep Endometriosis; Pelvic Pain; Neurogenesis; Endometriotic Nodule; Laparoscopy; Endometriosis Surgery

Outcome Measures

Primary Outcomes (2)

• Density of Neuro-Angiogenesis

  Density of nerve fibers and capillaries in each 1 cm peritoneal leaf which excised during laparoscopic endometriosis surgery

  6 months

• Density of Pain Mediators in Pelvic Peritoneum

  Density of Substance-P, Bradykinin, Nerve Growth Factor and PGP 9.5 in each peritoneal leaf which excised during surgery

  6 months

Secondary Outcomes (1)

• Relationship between Neuro-Angiogenesis Density and Pelvic Pain Scores

  6 months

Study Arms (1)

Study Group

EXPERIMENTAL

This study has only one group, the group includes patients with laparoscopic endometriosis surgery (douglasectomy).

Procedure: Laparoscopic Endometriosis Surgery

Interventions

Laparoscopic Endometriosis Surgery PROCEDURE

Laparoscopic Excision of Deep Endometriotic Nodule related to pelvic pain

Study Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with suspicion of deep endometriosis (Physical Examination and MRI)
• Patients with ineffective response to medical therapy
• Patients who undergo laparoscopic conservative endometriosis surgery (douglasectomy)

You may not qualify if:

• Patients with malignity suspicion
• Patients with extensive surgery (hysterectomy, ovariectomy)
• Patients with previous endometriosis or another pelvic surgery
• Patients with oocyte pick up procedure history
• Patients with pelvic inflammatory disease history

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University Faculty Hospital

Bursa, Gorukle, 16285, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gurkan Uncu, Prof.

  Uludag University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: December 1, 2023
• Primary Completion: April 23, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)