Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer

Comparison Between Laparoscopic Radical Hysterectomy Based on Space Anatomy and Abdominal Radical Hysterectomy for Stage IB3 and IIA2 Cervical Cancer: a Multicenter Retrospective Cohort Study

Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Locally Advanced Cervical Cancer
• Intervention / Treatment: Procedure: Laparoscopic radical hysterectomy based on space anatomy; Procedure: Abdominal radical hysterectomy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Sibang Chen; Phone Number: +86 18721757863; Email: sibang_chen@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who clinically diagnosed with IB3 and IIA2 cervical cancer are retrospectively collected from electronic medical records of four tertiary medical center from January 2012 to January 2022

Description

Inclusion Criteria:

1. Aged between 20 to 70 years
2. Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
3. Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
4. no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.

Exclusion Criteria:

1. patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
2. pregnancy;
3. incomplete radical surgery;
4. follow-up time less than 6 months or lost to follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LRH group; In this group, patients received a modified laparoscopic radical hysterectomy(LRH) based on space antomy.	Procedure: Laparoscopic radical hysterectomy based on space anatomy; This is a modified laparoscopic radical hysterectomy based on space anatomy. By identifying the vesicouterine ligament and four associated special spaces, the ureter can be completely liberated from the external aspect of the uterus. This skill not only reduces rate of surgical complications but also facilitates optimal tumor resection.
ARH group; In this group, patients received a traditional abdominal radical hysterectomy(ARH). ARH group is defined as a control group.	Procedure: Abdominal radical hysterectomy; This producre is a classic and traditional radical hysterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time from end of surgery to death from any cause.	5 years
Progression-free survival	The time from end of surgery to either the first documented disease progression or death from any cause.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery complication rate	Including the rates of ureter or bladder injury, colon injury, deep vein thrombosis event and infection.	Intraoperative or within 2 weeks after surgery
Intraoperative blood loss		Intraoperative blood loss

Collaborators and Investigators

• Sponsor: International Peace Maternity and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 27, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: GKLW-A-2024-111-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No