Changes in Uterine Artery Resistance Index Following Cervical Conization

NCT07653191 | Completed

• 1 other identifier: 189
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective study is to evaluate the hemodynamic impact of cervical conization on uterine artery blood flow by focusing on the Resistance Index (RI) as a direct indicator of distal vascular resistance. The central hypothesis is predicated on the physiological principle that the surgical excision and subsequent sealing of terminal cervical branches during conization increases the distal vascular impedance (afterload) encountered by the main uterine artery. Uterine artery Doppler RI measurements are performed preoperatively and at one month postoperatively to assess these alterations.

Conditions

Cervical Intraepithelial Neoplasia; Uterine Artery Hemodynamics

Keywords

Cervical conization; Uterine artery Doppler; Resistance index; Vascular resistance; Pregnancy complications

Outcome Measures

Primary Outcomes (1)

• Change in Uterine Artery Resistance Index (RI)

  Evaluation of bilateral uterine artery Doppler Resistance Index (RI) waveforms to measure modifications in downstream distal vascular resistance following microvascular occlusion.

  Preoperatively and at 1 month postoperatively

Study Arms (2)

Suture Group

EXPERIMENTAL

Participants assigned to undergo cervical conization with the placement of hemostatic 1/0 absorbable polyglycolic acid sutures at the 3 and 9 o'clock positions of the cervix for traction and immediate hemostasis.

Procedure: Cervical Conization

No Suture Group

ACTIVE COMPARATOR

Participants assigned to undergo the cervical conization procedure executed without the placement of any 3 and 9 o'clock cervical lateral sutures.

Procedure: Cervical Conization

Interventions

Cervical Conization PROCEDURE

Surgical excision of a symmetric cervical cone specimen surrounding the endocervical canal. The procedure is executed under general anesthesia using electrocautery via the Covidien Forcetriad energy platform with restricted power levels (Coagulation: 40 W, Cutting: 40 W) to minimize secondary thermal tissue damage.

No Suture Group; Suture Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Regularly menstruating female patients aged between 30 and 50 years.
• Definitive clinical indication for cervical conization based on abnormal cervical cytology, positive HPV screening, or colposcopy-guided biopsy findings.

You may not qualify if:

• Concomitant pelvic pathologies that could independently alter uterine artery blood flow or Doppler indices, such as uterine fibroids, ovarian cysts, endometriosis, pelvic inflammatory disease (PID), or hydrosalpinx.
• Acute postoperative bleeding complications.

Sponsors & Collaborators

• Adana City Training and Research Hospital: lead

Study Sites (1)

Adana City Training and Research Hospital

Adana, 01230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Pregnancy Complications

Interventions

Conization

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gorkem Ulger, M.D.

  Niğde Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independent specialist performing all preoperative and postoperative transvaginal Doppler evaluations was completely blinded to the intraoperative details and surgical modification groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Gynecological Oncology Surgery Specialist

Model Details: A randomized parallel group design evaluating patients who undergo cervical conization either with or without the placement of hemostatic sutures at the 3 and 9 o'clock positions.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 20, 2018
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)