To hear about similar clinical trials, please enter your email below
Trial Title:
Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer
NCT ID:
NCT05904977
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Cervical cancer
Radical hysterectomy
Ultrastaging
Vesicouterine ligament
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Procedure
Intervention name:
Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)
Description:
The patients with cervical cancer who underwent abdominal radical hysterectomy（type
C）plus pelvic lymph node dissection by the same surgical team at the Department of
Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were
included. According to the resection range of the anterior leaf of vesicouterine ligament
(VUL), patients were divided into type C resection group (near the bladder wall) and B
type resection group (above the ureter).
Arm group label:
Type B resection
Arm group label:
Type C resection
Summary:
The purpose of this study is to preliminarily explore the metastatic rate and clinical
significance of the anterior leaf of vesicouterine ligament resection for early stage
cervical cancer, so as to further improve the postoperative quality of life of patients
and reduce the incidence of postoperative urinary complications.
Detailed description:
The patients with cervical cancer who underwent abdominal radical hysterectomy（type
C）plus pelvic lymph node dissection by the same surgical team at the Department of
Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were
included. According to the resection range of the anterior leaf of vesicouterine ligament
(VUL), patients were divided into type C resection group (near the bladder wall) and B
type resection group (above the ureter). The anterior leaf of the VUL in the type C
resection group was sent to pathological biopsy separately, and the metastasis rate was
further clarified by the pathological "ultrastaging" method. By comparing the
clinicopathological characteristics of patients with metastasis and non-metastasis, the
potential risk factors of VUL metastasis were analyzed. The oncological outcomes of
patients with different resection range of the anterior VUL were compared. At the same
time, the Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer
patient quality of life score table was used to evaluate cervical cancer patients after
surgery. The relevant factors that may affect the quality of life score are included in
the multiple linear regression analysis to obtain independent risk factors that affect
the quality of life of the patient after surgery.
Criteria for eligibility:
Study pop:
The patients with cervical cancer who underwent abdominal radical hysterectomy（type
C）plus pelvic lymph node dissection by the same surgical team at the Department of
Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were
included. According to the resection range of the anterior leaf of vesicouterine ligament
(VUL), patients were divided into type C resection group (near the bladder wall) and B
type resection group (above the ureter).
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical
carcinoma (even neuroendocrine or clear cell carcinoma)
2. Radiographically confirmed tumor limited to the cervix or upper third vagina, but
without evidence of lymph node metastasis
3. Stage IA2-IIA2 ( FIGO 2018)
4. Treated initially or just underwent cervical conization before
5. Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic
lymph node dissection by the same team
6. Underwent the bilateral type C AL-VUL resection during the surgery
7. The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
1. Not stage IA2-IIA2 ( FIGO 2018)
2. History of abdominal or pelvic radiotherapy
3. Evidence of metastatic disease detected by PECT, MRI or CT
4. The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy
or the patient as refusing abdominal surgery
5. Patients with other mailgnant tumors except cervical cancer
6. Incompetence of the clinical, surgical and pathological data
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Huaiwu Lu
Address:
City:
Guangzhou
Zip:
520120
Country:
China
Status:
Recruiting
Contact:
Last name:
Huaiwu Lu
Phone:
18688395806
Email:
luhuaiwu@mail.sysu.edu.cn
Start date:
April 1, 2019
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05904977
