High-Grade Squamous Intraepithelial LesionsNCT06325592
Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL
An observational study of High-Grade Squamous Intraepithelial Lesions, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- High-Grade Squamous Intraepithelial Lesions
- What is being tested?
- surgical timing and operation path
- Type of treatment
- Surgery or procedure
- How many people
- 826 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610000
About this study
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
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.
- Being tested
- surgical timing and operation path
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical timing and operation pathProcedure or surgery
surgical timing; laparoscopic hysterectomy or abdominal hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| group 1 | patients underwent laparoscopic hysterectomy within 3 days after LEEP Receives: Procedure: surgical timing and operation path | |
| group 2 | patients underwent abdominal hysterectomy within 3 days after LEEP Receives: Procedure: surgical timing and operation path | |
| group 3 | patients underwent laparoscopic hysterectomy 4 weeks after LEEP Receives: Procedure: surgical timing and operation path | |
| group 4 | underwent abdominal hysterectomy 4 weeks after LEEP Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative fever
Use a thermometer to measure your temperature
Measured: Within 7 days of surgery
Postoperative therapeutic use of antibiotics
Postoperative therapeutic use of antibiotics
Measured: Within 7 days of surgery
Secondary outcomes (7)
Postoperative complications
Postoperative complications
Measured: Within 7 days of surgery
Postoperative hospitalization days
Postoperative hospitalization days
Measured: Date of surgery to date of discharge
Postoperative hemoglobin
Postoperative hemoglobin
Measured: Within 7 days of surgery
Postoperative white blood cell count
Postoperative white blood cell count
Measured: Within 7 days of surgery
Postoperative erythrocyte count
Postoperative erythrocyte count
Measured: Within 7 days of surgery
Postoperative albumin number
Postoperative albumin number
Measured: Within 7 days of surgery
Postoperative CRP value
Postoperative CRP value
Measured: Within 7 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Oct 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dengfeng Wang, Sichuan Cancer Hospital and Research Institute
- Investigators
- Dengfeng Wang, Ph.D, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325592
- Sponsor's protocol ID
- REHSIL2023V1.1
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06325592
- Acronym / sponsor ID
- REHSIL2023V1.1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: surgical timing and operation pathpatients underwent laparoscopic hysterectomy within 3 days after LEEP |
| group 2 | – | Procedure: surgical timing and operation pathpatients underwent abdominal hysterectomy within 3 days after LEEP |
| group 3 | – | Procedure: surgical timing and operation pathpatients underwent laparoscopic hysterectomy 4 weeks after LEEP |
| group 4 | – | Procedure: surgical timing and operation pathunderwent abdominal hysterectomy 4 weeks after LEEP |
| control group | – | –Patients who underwent laparoscopic hysterectomy (LH) due to benign gynecological diseases were included in the control group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical timing and operation pathsurgical timing; laparoscopic hysterectomy or abdominal hysterectomy | Procedure or surgery | group 1, group 2, group 3, group 4 |
Primary outcome
Postoperative fever
Time frame: Within 7 days of surgery
Use a thermometer to measure your temperature
Postoperative therapeutic use of antibiotics
Time frame: Within 7 days of surgery
Postoperative therapeutic use of antibiotics
7 secondary outcomes
Postoperative complications
Time frame: Within 7 days of surgery
Postoperative hospitalization days
Time frame: Date of surgery to date of discharge
Postoperative hemoglobin
Time frame: Within 7 days of surgery
Postoperative white blood cell count
Time frame: Within 7 days of surgery
Postoperative erythrocyte count
Time frame: Within 7 days of surgery
Postoperative albumin number
Time frame: Within 7 days of surgery
Postoperative CRP value
Time frame: Within 7 days of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dengfeng Wang, Ph.D principal investigator
Sichuan Cancer Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-Grade Squamous Intraepithelial Lesions, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative fever (time frame: Within 7 days of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.