Laparoscopic Versus Open Radical Hysterectomy in Early-Stage Cervical Cancer

NCT07626996 | Completed

• 1 other identifier: LAPvsOPEN-RH-Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

Radical Hysterectomy; Laparoscopic Surgery; Early-Stage Cervical Cancer; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Recurrence Rate

  Up to 3 years postoperatively

Study Arms (2)

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.

Procedure: Laparoscopic Radical Hysterectomy

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.

Procedure: Open Radical Hysterectomy

Interventions

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.

Laparoscopic Radical Hysterectomy

Open Radical Hysterectomy PROCEDURE

A standard open abdominal radical hysterectomy includes dissection of the pelvic lymph nodes and the closure of the vaginal stump.

Open Radical Hysterectomy

Eligibility Criteria

• Age: 38 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, Egypt

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ola A Harb, Professor

  Zagazig University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open-label study due to the nature of the surgical interventions, where neither participants nor investigators were blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: June 4, 2026
• Study Start: March 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)