Scientific Description This is a retrospective observational study with prospective
follow-up designed to evaluate the long-term oncologic safety and perioperative outcomes
of radical laparoscopic hysterectomy compared to abdominal (open) radical hysterectomy in
women with early-stage cervical cancer. The study specifically addresses surgical
management practices adopted after the publication of the Laparoscopic Approach to
Cervical Cancer (LACC) trial, which reported inferior oncologic outcomes associated with
minimally invasive surgery (MIS) for radical hysterectomy.
The primary objective of this study is to compare overall survival (OS) and
progression-free survival (PFS) between the two surgical approaches. Secondary objectives
include assessment of short-term surgical morbidity, recurrence patterns, and demographic
and clinical factors potentially associated with adverse outcomes.
Study Population Eligible participants will be adult (≥18 years), legally competent women
diagnosed with early-stage cervical cancer, defined as FIGO 2018 stages IB1 to IIA1,
excluding IB3 tumors. All patients must have negative sentinel lymph node biopsy (SNB)
results confirmed by ultrastaging.
To ensure homogeneity and minimize confounding associated with surgical technique, strict
intraoperative criteria will be applied:
Use of a uterine manipulator is not permitted; A protective vaginal cuff closure maneuver
(e.g., by suture, clamp, or stapler) must be performed to prevent tumor spillage during
colpotomy; SNB may be performed as a first step, followed by radical hysterectomy
classified as type B or C according to the Querleu-Morrow classification; Preoperative
conization is allowed but not mandatory.
Study Design This is a retrospective cohort study with prospective follow-up. Surgical
and perioperative data will be collected retrospectively from medical records. Eligible
patients who underwent radical hysterectomy by either laparoscopic or abdominal approach
in the post-LACC era will be identified and included.
Prospective follow-up will be conducted over a minimum period of 5 years, with
evaluations scheduled at 6-month intervals.
Each follow-up visit will include:
Gynecological examination and transvaginal and/or transabdominal ultrasound; In
symptomatic patients, additional imaging including contrast-enhanced CT scan of the
chest, abdomen, and pelvis, and pelvic MRI as clinically indicated.
Endpoints
Primary endpoints:
Overall survival (OS): Time from radical hysterectomy to death from any cause.
Progression-free survival (PFS): Time from radical hysterectomy to first documented
recurrence or death.
Secondary endpoints:
Surgical complication rates within 30 and 60 days postoperatively, categorized using the
Clavien-Dindo classification; Anatomic site and mode of recurrence (local, regional, or
distant); Duration of surgery; Demographic and clinical variables, including age, BMI,
tumor size, histologic subtype, and lymphovascular space invasion (LVSI).
Data Collection and Management Data will be extracted from patient medical records,
surgical reports, pathology reports, and follow-up documentation. No study-specific
interventions will be introduced beyond the standard follow-up protocol consistent with
national and institutional guidelines for cervical cancer surveillance.
All clinical, surgical, and outcome data will be anonymized and stored securely. Data
analysis will involve time-to-event methods (Kaplan-Meier curves, Cox proportional
hazards models) and comparative statistics (e.g., chi-square, t-test, or non-parametric
equivalents as appropriate).
Scientific Rationale The LACC trial demonstrated inferior disease-free and overall
survival outcomes for minimally invasive radical hysterectomy compared to open surgery,
which prompted a global shift in surgical practice. However, methodological
concerns-including inconsistent use of uterine manipulators, absence of protective
colpotomy techniques, and variability in surgeon experience-may have influenced the
observed outcomes.
This study seeks to investigate whether meticulous surgical technique, standardized
intraoperative precautions (such as omission of uterine manipulators and protective
closure of the vaginal cuff), and proper patient selection (i.e., early-stage tumors with
negative SNB) can mitigate the risks previously associated with the laparoscopic
approach.
By comparing outcomes in a well-defined cohort treated after dissemination of the LACC
trial results, this study aims to provide contemporary, real-world data on the oncologic
safety of laparoscopic radical hysterectomy in selected early-stage cervical cancer
patients.
