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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Radical Hysterectomy | Experimental | 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. |
|
| Open Radical Hysterectomy | Active Comparator | Under conventional surgical techniques in this group , participants underwent open abdominal radical hysterectomy with bilateral adnexectomy and dissection of pelvic lymph nodes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Radical Hysterectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | The surgery duration will be measured in minutes from skin incision to closure. | Intraoperative period (day of surgery) |
| Intraoperative Blood Loss volume | Assessment of volume of intraoperative blood loss (mL): Estimated blood loss volume measured in millilitres during surgery. | Intraoperative period |
| Length of Hospital Stay | Duration of hospital stay measured in days from surgery to discharge | Up to 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate | Assessment of cancer recurrence following surgical intervention during the follow-up period. | Up to 3 years postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ola A Harb, Professor | Zagazig University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University Hospitals | Zagazig | Sharqia Province | Egypt |
Data contains patient information
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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The study Participants were assigned into two parallel groups to undergo either laparoscopic-assisted radical hysterectomy or open radical hysterectomy. The study compares perioperative and long-term oncological outcomes between the two surgical approaches.
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This study is an open-label study due to the nature of the surgical interventions, where neither participants nor investigators were blinded
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| Open Radical Hysterectomy | Procedure | A standard open abdominal radical hysterectomy includes dissection of the pelvic lymph nodes and the closure of the vaginal stump. |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |