Modified Tumor-free Techniques Operation to Cervical Cancer
ConditionCervical Cancer Stage IB2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorPeking Union Medical College Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
Procedure/SurgeryThoroughly 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.
Abdominal radical hysterectomy
Procedure/SurgeryAt 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.
Treatment groups
524 Participants
are divided into 2 treatment groupsGroup A: LRH-MTFExperimental treatment 1 intervention
Group B: ARHActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
4.5-year Disease-free Survival
The time from the surgery 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 the surgery to the 4.5 years after the end of treatmentSecondary outcomes
1
4.5-year Overall Survival
The time interval from the surgery to death from any cause within 4.5 years after surgery.
Time frame
From the surgery to the 4.5 years after the end of treatment2
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 treatment3
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 hours4
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 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Hebei Medical University Fourth Hospital
Collaborator
Second Hospital of Jilin University
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Cangzhou Central Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Hunan Provincial Maternal and Child Health Care Hospital
Collaborator
LanZhou University
Collaborator
RenJi Hospital
Collaborator
The Fourth Military Medical University, Xijing Hospital
Collaborator
Shaanxi Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of North Sichuan Medical College
Collaborator
Tianjin Central Hospital of Gynecology Obstetrics
Collaborator
Southwest Hospital, China
Collaborator
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Source ClinicalTrials.gov