Clinical trial NCT06325592: Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-Grade Squamous Intraepithelial Lesions
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 826
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative fever
timeFrame: Within 7 days of surgery
measure: Postoperative therapeutic use of antibiotics
timeFrame: Within 7 days of surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: Within 7 days of surgery
measure: Postoperative hospitalization days
timeFrame: Date of surgery to date of discharge
measure: Postoperative hemoglobin
timeFrame: Within 7 days of surgery
measure: Postoperative white blood cell count
timeFrame: Within 7 days of surgery
measure: Postoperative erythrocyte count
timeFrame: Within 7 days of surgery
measure: Postoperative albumin number
timeFrame: Within 7 days of surgery
measure: Postoperative CRP value
timeFrame: Within 7 days of surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Dengfeng Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: