Cervical Cancer Stage IB2MOTTONCT06836869

Modified Tumor-free Techniques Operation to Cervical Cancer

A study testing Laparoscopic radical hysterectomy incorporating modified tumor-free techniques and Abdominal radical hysterectomy in people with Cervical Cancer Stage IB2, run by Peking Union Medical College Hospital at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Cervical Cancer Stage IB2
What is being tested?: Laparoscopic radical hysterectomy incorporating modified tumor-free techniques and Abdominal radical hysterectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 524 participants
Where: 17 sitesChina
Study dates: 20 Feb 2025to Jul 2032
Phase: Interventional
Are there results?: Not yet: the study is under way

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 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Inclusion Criteria: 1.1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 1.3 FIGO 2018 stage IB2. 1.4 The maximum diameter of the cervical lesion measured by MRI is >2 cm and ≤4 cm. For those with MRI contraindications, PET/CT, CT, or ultrasound can be used as alternatives. 1.5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 1.7 Willing to participate in this trial and sign the informed consent form. 1.8 Able to cooperate and complete follow - up and relevant examinations. 1.9 For pre - menopausal women, a negative pregnancy test within 30 days before surgery. 1.10 Laboratory test indicators of vital organs meet the standards
Exclusion Criteria:

2.1 Special pathological types (gastric - type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma, etc.).

2.2 Imaging examinations suggest pelvic or para - aortic lymph node metastasis (MRI or CT shows a short - axis diameter of ≥1.5 cm, or SUV ≥2.5), or histopathology indicates lymph node metastasis.

2.3 History of pelvic and abdominal radiotherapy. 2.4 History of neoadjuvant chemotherapy. 2.5 Uterus larger than that at 10 weeks of pregnancy. 2.6 Contraindications for surgery and anesthesia (such as severe medical comorbidities).

2.7 Patients who cannot tolerate the Trendelenburg position. 2.8 Patients who cannot cooperate with treatment and follow - up. 2.9 Pregnant patients. 2.10 History of other malignancies, except for those who have been cancer - free for more than 3 years with no current evidence of tumor recurrence.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuan Li, professor contact

+8617810376318

liyuan10833@pumch.cn

City, postcode or hospital

Sites recruiting now only

17 sites in 1 country

China17 sites, 17 recruiting

Peking Union Medical College Hospital
Beijing, 100079
Yuan Li, professor, +8617810376318, liyuan10833@pumch.cn
Jiayuan Zhao, MD, zhaojy1221@126.com
Recruiting
Cangzhou Central Hospital
Cangzhou, Hebei, 061000
Shikai Liu, professor, commasll@163.com
Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Tianmin Xu, professor, xutianmin@126.com
Recruiting
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, 410000
Chuqiang Shu, professor, siqing9999@163.com
Recruiting
Sichuan Cancer Hospital and Institute
Chengdu
Dengfeng Wang, 8615982222707, zhanggn@hotmail.com
Recruiting
Southwest Hospital
Chongqing
Jinjin Li, 8618883938300, wangyanzhou1981@126.com
Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Huaiwu Lu, professor, luhuaiwu@mai.sysu.edu.cn
Recruiting
Zhejiang cancer hospital
Hangzhou, Zhejiang, 310022
Tao Zhu, professor, +8613858065156, zhutao@zjcc.org.cn
Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Chang Liu, professor, lch@lzu.edu.cn
Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Aiping Wen, professor, +8613890893965, 369563889@qq.com
Chengchao Du, professor, +8615082471020, 854803952@qq.com
Recruiting
Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, 200001
Kaijiang Liu, professor, liukaijiang@263.net
Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai
Lin Qiu, 8615221848983, wuxin_fc@fudan.edu.cn
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Shan Kang, professor, kangshan@hebmu.edu.cn
Recruiting
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin
Yuanjing Hu, 18920196053, julianna_hu@163.com
Hu
Recruiting
Tongji Medical College
Wuhan
Peng Wu, 8613995573729, pengwu8626@tjh.tjmu.edu.cn
Recruiting
The Fourth Military Medical University, Xijing Hospital
Xi’an, Shanxi, 710032
Wei Zhang, professor, +8618049504994, doctor_zw@sina.com
Recruiting
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
Xianyang, Shanxi, 712000
Fei Li, professor, 13595024@qq.com
Recruiting

Other trials in China

About this study

Official title: A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer

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:

Undergo either LRH-MTF or ARH as assigned by randomization.
Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications.
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).

Read the detailed description

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.

Conditions: Cervical Cancer Stage IB2
Being tested: Laparoscopic radical hysterectomy incorporating modified tumor-free techniques, Abdominal radical hysterectomy
Keywords: radical hysterectomy, Modified Tumor-Free Techniques, cervical cancer, FIGO stage 1B2, laparotomy, laparoscopic surgery
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoscopic radical hysterectomy incorporating modified tumor-free techniquesProcedure or surgery
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.
Abdominal radical hysterectomyProcedure or surgery
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.

Study groups in NCT06836869
Study group	Role	What they receive
LRH-MTF	Experimental	Laparoscopic radical hysterectomy incorporating modified tumor-free techniques Receives: Procedure: Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
ARH	Active comparator	Abdominal radical hysterectomy Receives: Procedure: Abdominal radical hysterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From the surgery to the 4.5 years after the end of treatment

Secondary outcomes (12)

4.5-year Overall Survival
The time interval from the surgery to death from any cause within 4.5 years after surgery.
Measured: From the surgery 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From surgery to the third day after surgery
Gastrointestinal function recovery
Record the time (in hours) of the first postoperative flatus.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the 4.5 years after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 2025Jul 2032

First posted20 Feb 2025
Study start20 Feb 2025
Primary completionJul 2032 (estimated)
Study completionJul 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cervical Cancer Stage IB2Studies of the same condition, open and under way.
More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a prospective, multi-center, open-label, blind endpoint evaluation (PROBE), non-inferiority, randomized controlled trial with a parallel-group design. The main hypothesis of this study is that laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) is non-inferior to abdominal radical hysterectomy (ARH) in terms of disease-free survival at 4.5 years post-operation. A non-inferiority margin of 7% is set based on previous studies. This means that as long as the difference in the 4.5-year disease-free survival rate between LRH-MTF and ARH is within this non-inferiority margin, LRH-MTF will be considered non-inferior to ARH. If LRH-MTF meets this criterion, it can potentially offer the advantages of minimally invasive surgery, such as reduced surgical trauma, shorter hospital stay, and faster recovery, while maintaining comparable oncological outcomes.
Masking: None (open label)
Enrolment: 524 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06836869
Sponsor's protocol ID: MOTTO
Acronym: MOTTO
Status last verified: Mar 2026
First submitted: 11 Feb 2025
Last updated: 27 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD used in the results publication will be shared.

Publications

Kanao H, Aoki Y, Fusegi A, Omi M, Nomura H, Tanigawa T, Okamoto S, Kurita T, Netsu S, Omatsu K, Yunokawa M. Feasibility and Outcomes of "No-Look No-Touch" Laparoscopic Radical Trachelectomy for Early-Stage Cervical Cancer. J Clin Med. 2021 Sep 15;10(18):4154. doi: 10.3390/jcm10184154.
PubMed 34575265
Chiva L, Zanagnolo V, Querleu D, Martin-Calvo N, Arevalo-Serrano J, Capilna ME, Fagotti A, Kucukmetin A, Mom C, Chakalova G, Aliyev S, Malzoni M, Narducci F, Arencibia O, Raspagliesi F, Toptas T, Cibula D, Kaidarova D, Meydanli MM, Tavares M, Golub D, Perrone AM, Poka R, Tsolakidis D, Vujic G, Jedryka MA, Zusterzeel PLM, Beltman JJ, Goffin F, Haidopoulos D, Haller H, Jach R, Yezhova I, Berlev I, Bernardino M, Bharathan R, Lanner M, Maenpaa MM, Sukhin V, Feron JG, Fruscio R, Kukk K, Ponce J, Minguez JA, Vazquez-Vicente D, Castellanos T, Chacon E, Alcazar JL; SUCCOR study Group. SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer. Int J Gynecol Cancer. 2020 Sep;30(9):1269-1277. doi: 10.1136/ijgc-2020-001506. Epub 2020 Aug 11.
PubMed 32788262
Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.
PubMed 30380365
Li Y, Zhao J, Ding X, Liang C, Wang W, Ren T, Jiang F, Yang J, Xiang Y. Oncologic Outcomes of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-Free Techniques. Obstet Gynecol. 2025 Feb 1;145(2):134-143. doi: 10.1097/AOG.0000000000005805. Epub 2024 Dec 19.
PubMed 39700500

Interested in taking part?

Yuan Li, professor

+8617810376318

liyuan10833@pumch.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Active, not recruitingPhase 2
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
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RecruitingObservational study
Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix
Cervical Large Cell Neuroendocrine Carcinoma, Cervical Neuroendocrine Carcinoma

All Cervical Cancer Stage IB2 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer
ClinicalTrials.gov ID: NCT06836869
Acronym / sponsor ID: MOTTO / MOTTO
Conditions: Cervical Cancer Stage IB2
Keywords: radical hysterectomy, Modified Tumor-Free Techniques, cervical cancer, FIGO stage 1B2, laparotomy, laparoscopic surgery
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 524 participants (estimated)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Collaborators: Hebei Medical University Fourth Hospital, Second Hospital of Jilin University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Cangzhou Central Hospital, Zhejiang Cancer Hospital, Hunan Provincial Maternal and Child Health Care Hospital, LanZhou University, RenJi Hospital, The Fourth Military Medical University, Xijing Hospital, Shaanxi Hospital of Traditional Chinese Medicine, Afﬁliated Hospital of North Sichuan Medical College, Tianjin Central Hospital of Gynecology Obstetrics, Southwest Hospital, China, Obstetrics & Gynecology Hospital of Fudan University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sichuan Cancer Hospital and Research Institute
Study start: 20 Feb 2025 (actual)
Primary completion: Jul 2032 (estimated)
Study completion: Jul 2032 (estimated)
First posted: 20 Feb 2025 (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.

Participants will:

Undergo either LRH-MTF or ARH as assigned by randomization.
Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications.
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).

Detailed description

The study will perform one final analysis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a prospective, multi-center, open-label, blind endpoint evaluation (PROBE), non-inferiority, randomized controlled trial with a parallel-group design. The main hypothesis of this study is that laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) is non-inferior to abdominal radical hysterectomy (ARH) in terms of disease-free survival at 4.5 years post-operation. A non-inferiority margin of 7% is set based on previous studies. This means that as long as the difference in the 4.5-year disease-free survival rate between LRH-MTF and ARH is within this non-inferiority margin, LRH-MTF will be considered non-inferior to ARH. If LRH-MTF meets this criterion, it can potentially offer the advantages of minimally invasive surgery, such as reduced surgical trauma, shorter hospital stay, and faster recovery, while maintaining comparable oncological outcomes.

Arm	Type	Receives
LRH-MTF	Experimental	Procedure: Laparoscopic radical hysterectomy incorporating modified tumor-free techniquesLaparoscopic radical hysterectomy incorporating modified tumor-free techniques
ARH	Active comparator	Procedure: Abdominal radical hysterectomyAbdominal radical hysterectomy

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Laparoscopic radical hysterectomy incorporating modified tumor-free techniquesThoroughly 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.	Procedure or surgery	LRH-MTF
Abdominal radical hysterectomyAt 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.	Procedure or surgery	ARH

Primary outcome

4.5-year Disease-free Survival
Time frame: From the surgery to the 4.5 years after the end of treatment
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.

12 secondary outcomes

4.5-year Overall Survival
Time frame: From the surgery to the 4.5 years after the end of treatment
Pattern of Reccurence
Time frame: From surgery to the 4.5 years after the end of treatment
Estimated surgical blood loss
Time frame: From the start to the end of the surgery up to 24 hours
Operating time
Time frame: From the start to the end of the surgery up to 24 hours
Postoperative pain
Time frame: From surgery to the third day after surgery
Gastrointestinal function recovery
Time frame: From the end of surgery to the first postoperative flatus at 7 days.
Length of hospital stay
Time frame: From hospitalization to discharge up to 90 days.
Treatment cost
Time frame: From enrollment to the 4.5 years after the end of treatment
EORTC QLQ - C30 scale
Time frame: From enrollment to the 4.5 years after the end of treatment
EORTC QLQ - CX24 Scale
Time frame: From enrollment to the 4.5 years after the end of treatment
FSFI Scale
Time frame: From enrollment to the 4.5 years after the end of treatment
FSDS - R Scale
Time frame: From enrollment to the 4.5 years after the end of treatment

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Background: PubMed 34575265Kanao H, Aoki Y, Fusegi A, Omi M, Nomura H, Tanigawa T, Okamoto S, Kurita T, Netsu S, Omatsu K, Yunokawa M. Feasibility and Outcomes of "No-Look No-Touch" Laparoscopic Radical Trachelectomy for Early-Stage Cervical Cancer. J Clin Med. 2021 Sep 15;10(18):4154. doi: 10.3390/jcm10184154.
Background: PubMed 32788262Chiva L, Zanagnolo V, Querleu D, Martin-Calvo N, Arevalo-Serrano J, Capilna ME, Fagotti A, Kucukmetin A, Mom C, Chakalova G, Aliyev S, Malzoni M, Narducci F, Arencibia O, Raspagliesi F, Toptas T, Cibula D, Kaidarova D, Meydanli MM, Tavares M, Golub D, Perrone AM, Poka R, Tsolakidis D, Vujic G, Jedryka MA, Zusterzeel PLM, Beltman JJ, Goffin F, Haidopoulos D, Haller H, Jach R, Yezhova I, Berlev I, Bernardino M, Bharathan R, Lanner M, Maenpaa MM, Sukhin V, Feron JG, Fruscio R, Kukk K, Ponce J, Minguez JA, Vazquez-Vicente D, Castellanos T, Chacon E, Alcazar JL; SUCCOR study Group. SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer. Int J Gynecol Cancer. 2020 Sep;30(9):1269-1277. doi: 10.1136/ijgc-2020-001506. Epub 2020 Aug 11.
Background: PubMed 30380365Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.
Background: PubMed 39700500Li Y, Zhao J, Ding X, Liang C, Wang W, Ren T, Jiang F, Yang J, Xiang Y. Oncologic Outcomes of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-Free Techniques. Obstet Gynecol. 2025 Feb 1;145(2):134-143. doi: 10.1097/AOG.0000000000005805. Epub 2024 Dec 19.
Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared.

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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.

Yuan Li, professor contact

+8617810376318

liyuan10833@pumch.cn

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuan Li, professor (+8617810376318, liyuan10833@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

4.5-year Disease-free Survival (time frame: From the surgery to the 4.5 years after the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06836869, which also lists 4 linked publications.

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 27 Mar 2026.