Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL

NCT06325592 | Completed

• 1 other identifier: REHSIL2023V1.1
• Study Type: observational
• Target: 826
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details.

Conditions

High-Grade Squamous Intraepithelial Lesions

Outcome Measures

Primary Outcomes (2)

• Postoperative fever

  Use a thermometer to measure your temperature

  Within 7 days of surgery

• Postoperative therapeutic use of antibiotics

  Postoperative therapeutic use of antibiotics

  Within 7 days of surgery

Secondary Outcomes (7)

• Postoperative complications

  Within 7 days of surgery

• Postoperative hospitalization days

  Date of surgery to date of discharge

• Postoperative hemoglobin

  Within 7 days of surgery

• Postoperative white blood cell count

  Within 7 days of surgery

• Postoperative erythrocyte count

  Within 7 days of surgery

Study Arms (5)

group 1

patients underwent laparoscopic hysterectomy within 3 days after LEEP

Procedure: surgical timing and operation path

group 2

patients underwent abdominal hysterectomy within 3 days after LEEP

Procedure: surgical timing and operation path

group 3

patients underwent laparoscopic hysterectomy 4 weeks after LEEP

Procedure: surgical timing and operation path

group 4

underwent abdominal hysterectomy 4 weeks after LEEP

Procedure: surgical timing and operation path

control group

Patients who underwent laparoscopic hysterectomy (LH) due to benign gynecological diseases were included in the control group.

Interventions

surgical timing and operation path PROCEDURE

surgical timing; laparoscopic hysterectomy or abdominal hysterectomy

group 1; group 2; group 3; group 4

Eligibility Criteria

• Gender Eligibility Details: Gynecological patient
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data were collected from patients with HSIL who underwent TH at the Gynecological Oncology Center of Sichuan Cancer Hospital between January 1, 2016, and October 31, 2023. Patients who underwent laparoscopic hysterectomy (LH) +/- bilateral fallopian tubes or bilateral adnexectomy for benign gynecological diseases (such as uterine fibroids and adenomyosis) were included in the control group (excluding patients with recent invasive operations of the cervix and vagina).

You may qualify if:

• patients were confirmed with HSIL through pathology at our hospital or another tertiary facility, with additional confirmation via pathological consultation at our facility;
• LH or abdominal hysterectomy (AH) +/- bilateral fallopian tube or bilateral adnexectomy was performed after LEEP;
• the patient had no history of systemic malignancies.

You may not qualify if:

• severe medical and surgical complications;
• an extensive or subextensive hysterectomy was performed;
• surgical removal scope involving tissues (such as lymph nodes) or organs (such as the appendix) other than the uterus, ovaries, and fallopian tubes;
• fever symptoms within the last month;
• incidence of pelvic and abdominal infections, vaginitis, or similar conditions within the past month.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Dengfeng Wang, Ph.D

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the first ward of Gynecology Oncology Department

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 22, 2024
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)