Laparoscopic Versus Open Radical Hysterectomy in Early-Stage Cervical Cancer (LAP-OPEN)
Radical Laparoscopic-assisted Hysterectomy Versus Open Radical Hysterectomy in Early-Stage Cervical Cancer: A Comparative Study
The study aims to compare laparoscopic-assisted radical hysterectomy with open radical hysterectomy in women with early-stage cervical cancer. A total of 60 patients diagnosed with FIGO stage IA1, IA2, and IB1 cervical cancer were enrolled and randomly assigned into two equal groups: laparoscopic surgery and open surgery. All patients underwent total hysterectomy, bilateral adnexectomy, and pelvic lymph node dissection.
Perioperative outcomes were evaluated, including operative time, blood loss, complications, and hospital stay, as well as long-term oncological outcomes such as recurrence, recurrence-free survival, and overall survival. Patients were followed for up to three years postoperatively. The findings of this study aim to assess the safety, feasibility, and clinical effectiveness of laparoscopic-assisted surgery compared with the conventional open approach in the management of early-stage cervical cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cervical cancer remains one of the leading causes of cancer-related morbidity and mortality among women worldwide. Radical hysterectomy is the standard surgical treatment for early-stage cervical cancer. Traditionally, this procedure has been performed through an open abdominal approach; however, minimally invasive techniques, including laparoscopic-assisted radical hysterectomy, have gained increasing attention due to their potential advantages in reducing surgical trauma and improving perioperative recovery.
This study was conducted to compare the clinical and oncological outcomes of laparoscopic-assisted radical hysterectomy versus open radical hysterectomy in patients with early-stage cervical cancer. A total of 60 patients diagnosed with FIGO stage IA1, IA2, and IB1 cervical cancer were included. Participants were admitted to Zagazig University Hospitals between March 2021 and January 2024.
Eligible patients were randomly assigned into two groups: a laparoscopic surgery group and an open surgery group. All patients underwent total hysterectomy, bilateral adnexectomy, and pelvic lymph node dissection. In the laparoscopic group, vaginal stump closure was performed using an endoscopic stapler, whereas in the open group, closure was performed using conventional surgical techniques.
Primary outcomes included perioperative parameters such as operative time, intraoperative blood loss, blood transfusion, complications, hospital stay, and time to removal of urinary catheter and drainage tube. Secondary outcomes included long-term oncological outcomes such as recurrence rate, recurrence-free survival, and overall survival. Patients were followed for up to three years postoperatively.
The study aimed to determine whether laparoscopic-assisted radical hysterectomy provides comparable safety and oncological outcomes to open surgery while offering potential advantages in perioperative recovery. This study was registered retrospectively, as patient enrollment had been completed prior to trial registration, in accordance with journal requirements and to ensure transparency in reporting.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Sharqia Province
-
Zagazig, Sharqia Province, Egipto
- Zagazig University Hospitals
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- FIGO stage IA1, IA2, IB1
- patients with a tumor size < 2 cm by MRI or pathological assessment after conization
- tumours with histopathological subtypes: squamous cell carcinoma, adenocarcinoma and adeno-squamous carcinoma (
- patients with adequate; hematopoietic, renal and liver functions:
- patients with BMI < 35 (
- patients with age range 38 - 65 years old.
Exclusion Criteria:
- patients with mental, heart, bladder, liver, or kidney illness
- patients who had received pre-operative chemotherapy or radiotherapy pregnant patients
- patients with incomplete data or lost follow-up
- patients with radiological evidence of invasion of the outer 1/3 of the cervical stroma or the lower uterine segment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Laparoscopic Radical Hysterectomy
In this study, participants underwent radical hysterectomy with bilateral adnexectomy and lymph node dissection using a laparoscopic approach, and vaginal stump closure using an endoscopic stapler was performed.
|
In this procedure, a minimally invasive laparoscopic-assisted radical hysterectomy is performed, including dissection of the pelvic lymph nodes and closure of the vaginal stump with an endoscopic stapler.
|
|
Comparador activo: Open Radical Hysterectomy
Under conventional surgical techniques in this group , participants underwent open abdominal radical hysterectomy with bilateral adnexectomy and dissection of pelvic lymph nodes.
|
A standard open abdominal radical hysterectomy includes dissection of the pelvic lymph nodes and the closure of the vaginal stump.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Operative Time
Periodo de tiempo: Intraoperative period (day of surgery)
|
The surgery duration will be measured in minutes from skin incision to closure.
|
Intraoperative period (day of surgery)
|
|
Intraoperative Blood Loss volume
Periodo de tiempo: Intraoperative period
|
Assessment of volume of intraoperative blood loss (mL): Estimated blood loss volume measured in millilitres during surgery.
|
Intraoperative period
|
|
Length of Hospital Stay
Periodo de tiempo: Up to 30 days post-surgery
|
Duration of hospital stay measured in days from surgery to discharge
|
Up to 30 days post-surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recurrence Rate
Periodo de tiempo: Up to 3 years postoperatively
|
Assessment of cancer recurrence following surgical intervention during the follow-up period.
|
Up to 3 years postoperatively
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Ola A Harb, Professor, Zagazig University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Neoplasias Genitales Femeninas
- Enfermedades del cuello uterino
- Neoplasias Uterinas
- Neoplasias del cuello uterino
Otros números de identificación del estudio
- LAPvsOPEN-RH-Study
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .