The goal of this clinical trial is to learn if laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) works to treat FIGO stage IB2 cervical cancer as good as abdominal radical hysterectomy (ARH). It will also learn about the safety of LRH-MTF. The main questions it aims to answer are: Does LRH-MTF achieve a non-inferior disease-free survival rate at 4.5 years post - operation compared to ARH? What complications do patients have during and after the operation when receiving LRH-MTF? Researchers will compare LRH-MTF to ARH to see if LRH-MTF works no worse than ARH in treating FIGO stage IB2 cervical cancer. Participants will: 1. Undergo either LRH-MTF or ARH as assigned by randomization. 2. Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications. 3. Complete quality-of-life questionnaires such as EORTC QLQ-C30, QLQ-CX24, FSFI, and FSDS-R at baseline (pre-operation) and specific time points during the follow - up period (post-operation 6 months, 1 year, 2 years, 3 years, 4.5 years).
A progress report will be conducted within 4 weeks after all participants have completed their 6-month postoperative visit (the 5th visit). The report will be performed by an independent third-party statistical team, which will provide a comprehensive analysis of the safety data, baseline characteristic, and perioperative indicators. The study will perform one final analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
524
Thoroughly examine the pelvic and abdominal cavities. Coagulation of the fallopian tubes are recommanded at the beginning of the surgery. The use of uterine manipulator is prohibited. An "8"-suture at the uterine fundus is recommended. Insert a trocar 3 cm above the pubic symphysis and suspend the uterus by pulling with a needle holder. Alternative methods are also acceptable. Perform pelvic lymphadenectomy. Conduct radical hysterectomy according to the Q-M classification type C. Before incising the vagina, the upper part of the vagina must be closed (using a cable tie or suture), or the vagina can be incised transvaginally after deflating the pneumoperitoneum. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity. The vaginal stump can be sutured either laparoscopically or transvaginally.
At the onset of surgery, comprehensively explore the pelvic and abdominal cavities. If intraperitoneal metastases are identified, radical hysterectomy should be aborted. Perform pelvic lymphadenectomy. After lymph node resection, remove the lymph nodes from the surgical field promptly. Sentinel lymph node mapping and biopsy are not performed in this study. Perform radical hysterectomy according to type C of the Q-M classification. It can be accompanied by or without bilateral salpingo - oophorectomy. For patients who retain their ovaries, bilateral ovarian transposition can be carried out. Before incising the vagina, close the upper segment of the vagina and/or the vaginal stump. This can be achieved using instruments such as a large right - angle clamp or an auricular clamp. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity.
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGCangzhou Central Hospital
Cangzhou, Hebei, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGHunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGThe Second Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGRenji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGAffiliated Hospital of Shanxi University of Traditional Chinese Medicine
Xianyang, Shanxi, China
NOT_YET_RECRUITINGThe Fourth Military Medical University, Xijing Hospital
Xi’an, Shanxi, China
NOT_YET_RECRUITINGAffiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
NOT_YET_RECRUITING...and 3 more locations
4.5-year Disease-free Survival
The time from randomization until the first recurrence or death from any cause within 4.5 years after surgery. Recurrence needs to be confirmed by histopathology and/or imaging. If pathological evidence cannot be obtained, recurrence should be determined by two or more detection methods, and adjudicated by an independent Endpoint Event Evaluation Committee.
Time frame: From enrollment to the 4.5 years after the end of treatment
4.5-year Overall Survival
The time interval from randomization to death from any cause within 4.5 years after surgery.
Time frame: From enrollment to the 4.5 years after the end of treatment
Pattern of Reccurence
According to the location of the first recurrence, it is divided into intra-pelvic recurrence and distant recurrence. Analyze the differences in the location of tumor recurrence after different surgical methods to provide a reference for subsequent treatment and prognosis judgment.
Time frame: From surgery to the 4.5 years after the end of treatment
Estimated surgical blood loss
Calculate it as the difference in the weight of gauze/gauze pads before and after the surgery (g) divided by 1.05, plus the difference between the total volume of aspirated fluid and the volume of irrigation fluid at the end of the surgery (mL). Also, record whether blood transfusion is performed during the surgery and within 1 week after the surgery. In addition, record the changes in hemoglobin before and after the surgery to assess blood loss. Perform a complete blood count (hemoglobin) test within 1 week before the surgery and on the 1st day after the surgery.
Time frame: From the start to the end of the surgery up to 24 hours
Operating time
The time from making the first incision to completing the suturing.
Time frame: From the start to the end of the surgery up to 24 hours
Postoperative pain
It is evaluated using the Visual Analogue Scale (VAS). Additionally, the types, quantities, and administration methods of postoperative analgesics are recorded.
Time frame: From surgery to the third day after surgery
Gastrointestinal function recovery
Record the time (in hours) of the first postoperative flatus.
Time frame: From the end of surgery to the first postoperative flatus at 7 days.
Length of hospital stay
The number of days from hospitalization to discharge.
Time frame: From hospitalization to discharge up to 90 days.
Treatment cost
The total cost of hospitalization and outpatient services related to this disease. Conduct cost - effectiveness analysis through incremental cost, improvement of functional outcomes, and quality - adjusted life - years.
Time frame: From enrollment to the 4.5 years after the end of treatment
EORTC QLQ - C30 scale
EORTC QLQ - C30 is short for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Each of the 15 subscales of the EORTC QLQ - C30 is scored from 0 to 100. For the functional scales (physical, role, emotional, cognitive, and social functioning), higher scores indicate better functioning and thus a better outcome. For the symptom scales (fatigue, nausea and vomiting, pain, etc.) and the global health status/QOL scale, a higher score on the symptom scales means more severe symptoms (a worse outcome), while a higher score on the global health status/QOL scale means a better quality of life. It is used to evaluate the quality of life at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
Time frame: From enrollment to the 4.5 years after the end of treatment
EORTC QLQ - CX24 Scale
EORTC QLQ - CX24 Scale is short for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Cervical Cancer Module. Similar to the QLQ - C30, most of its subscales are scored from 0 to 100. Interpretation of Scores: The interpretation is generally in line with the QLQ - C30. Higher scores in functional aspects indicate better conditions, while higher scores in symptom-related aspects indicate more severe symptoms or worse outcomes. It is used to evaluate the quality of life at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
Time frame: From enrollment to the 4.5 years after the end of treatment
FSFI Scale
FSFI is short for Female Sexual Function Index. Minimum and Maximum Values: The total score of the FSFI ranges from 2 to 36. Interpretation of Scores: A higher score indicates better female sexual function and a better outcome in terms of sexual health. Scores below a certain threshold may indicate sexual dysfunction. It is used to evaluate the sexual function at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
Time frame: From enrollment to the 4.5 years after the end of treatment
FSDS - R Scale
FSDS - R Scale is short for Female Sexual Distress Scale - Revised. Minimum and Maximum Values: The FSDS - R typically has a score range from 0 to 52. Interpretation of Scores: In this scale, a higher score indicates a higher level of sexual distress, meaning a worse outcome. It reflects the degree of distress a woman experiences related to her sexual function or situation. It is used to evaluate the sexual function at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
Time frame: From enrollment to the 4.5 years after the end of treatment
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