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

Association Between Surgical Timing and Route of Total Hysterectomy After Loop Electrosurgical Excision Procedure and Perioperative Risk in Patients With Cervical High-grade Squamous Intraepithelial Lesion

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.

Study Overview

• Status: Completed
• Conditions: High-Grade Squamous Intraepithelial Lesions
• Intervention / Treatment: Procedure: surgical timing and operation path

• Study Type: Observational
• Enrollment (Actual): 826

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Sichuan Cancer Hospital and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; patients underwent laparoscopic hysterectomy within 3 days after LEEP	Procedure: surgical timing and operation path; surgical timing; laparoscopic hysterectomy or abdominal hysterectomy
group 2; patients underwent abdominal hysterectomy within 3 days after LEEP	Procedure: surgical timing and operation path; surgical timing; laparoscopic hysterectomy or abdominal hysterectomy
group 3; patients underwent laparoscopic hysterectomy 4 weeks after LEEP	Procedure: surgical timing and operation path; surgical timing; laparoscopic hysterectomy or abdominal hysterectomy
group 4; underwent abdominal hysterectomy 4 weeks after LEEP	Procedure: surgical timing and operation path; surgical timing; laparoscopic hysterectomy or abdominal hysterectomy
control group; Patients who underwent laparoscopic hysterectomy (LH) due to benign gynecological diseases were included in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications	Within 7 days of surgery
Postoperative hospitalization days	Postoperative hospitalization days	Date of surgery to date of discharge
Postoperative hemoglobin	Postoperative hemoglobin	Within 7 days of surgery
Postoperative white blood cell count	Postoperative white blood cell count	Within 7 days of surgery
Postoperative erythrocyte count	Postoperative erythrocyte count	Within 7 days of surgery
Postoperative albumin number	Postoperative albumin number	Within 7 days of surgery
Postoperative CRP value	Postoperative CRP value	Within 7 days of surgery

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute
• Investigators: Principal Investigator: Dengfeng Wang, Ph.D, Sichuan Cancer Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Neoplasms, Squamous Cell; Uterine Cervical Dysplasia; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Carcinoma in Situ; Carcinoma, Squamous Cell; Squamous Intraepithelial Lesions of the Cervix
• Other Study ID Numbers: REHSIL2023V1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No