Trial conduct and oversight
tumor, vascular tumor thrombus, squamous cell carcinoma, adenocarcinoma, bladder dysfunction
TUMOR, RECURRENCE, RECURRENCE, ADENOSQUAMOUS CARCINOMA, COMPLICATIONS, KIDNEY DYSFUNCTION, SECONDARY, ENDOMETRIOID ADENOCARCINOMA, BLADDER DYSFUNCTION
Patients who met the following criteria were included in the study: (1) FIGO2018 stage IA1 (with vascular tumor thrombus), IA2, IB1; (2) the largest tumor diameter < 2 cm (MRI evaluation or pathological evaluation after conization < 2 cm); (3) histological types: squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, except endometrioid adenocarcinoma; (4) patients with appropriate bone marrow hematopoietic function and renal function; (5) liver function: ((1) white blood cell count > 3.0 × 10Patients with the following conditions were excluded: (1) mental illness; (2) heart, liver, or kidney dysfunction; (3) bladder dysfunction before the operation or patients with other serious complications who could not bear the risk of surgery; (4) patients who had received radiotherapy or chemotherapy; (5) pregnant patients; (6) lost to follow-up; (7) tumor diameter ≥ 2 cm; imaging evaluation showing that the cervical tumor invades the outer 1/3 of the stroma or involves the lower uterine segment; (8) patients with FIGO stage IB2 and above; (9) patients whose medical compliance and geographic location could not guarantee sufficient follow-up; (10) patients with surgical contraindications; (11) BMI ≥ 35.After signing a written consent, patients were randomly assigned by a network-based computer randomization program into the laparoscopy group and the laparotomy group at a ratio of 1:1. Masking was impossible because of the nature of the treatment.All patients underwent extensive hysterectomy and pelvic lymph node dissection (with or without bilateral adnexectomy). The primary study objective was to compare the clinical outcomes between the laparoscopic group that used the endocutter stapler for vaginal stump closure and the laparotomy group that used right-angled forceps to close the vaginal stump. The primary outcomes of interest included the patients’ perioperative observation indicators and short- and long-term period complications. Recurrence and overall survival were considered secondary outcomes. The primary endpoint is 4.5 years of post-operative DFS (the time interval from the surgery date to the first recurrence).