Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer

NCT ID: NCT03738969

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-10

Study Completion Date

2023-12-23

Brief Summary

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This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.

Detailed Description

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Conditions

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Uterine Cervical Neoplasms Laparotomy Laparoscopy Survival Mortality Recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Laparotomy group

Patients in this group accepted laparotomic radical hysterectomy for cervical cancer.

Laparotomic radical hysterectomy

Intervention Type PROCEDURE

Radical hysterectomy applied by laparotomy

Laparoscopy group

Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer.

Laparoscopic radical hysterectomy

Intervention Type PROCEDURE

Radical hysterectomy applied by laparoscopic

Interventions

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Laparotomic radical hysterectomy

Radical hysterectomy applied by laparotomy

Intervention Type PROCEDURE

Laparoscopic radical hysterectomy

Radical hysterectomy applied by laparoscopic

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pathological confirmed as uterine cervical cancer
* Having definite clinical information
* Having received radical hysterectomy or trachelectomy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

13911988831 ext. 86

Facility Contacts

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Lei Li, MD

Role: primary

13911988831 ext. 86

References

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Chao X, Wu M, Ma S, Tan X, Zhong S, Song X, Li L. Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China. BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020.

Reference Type DERIVED
PMID: 32819996 (View on PubMed)

Other Identifiers

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SACCC

Identifier Type: -

Identifier Source: org_study_id

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