Cervical CancerLAP-OPENNCT07626996
Laparoscopic Versus Open Radical Hysterectomy in Early-Stage Cervical Cancer
A study testing Laparoscopic Radical Hysterectomy and Open Radical Hysterectomy in people with Cervical Cancer, run by Zagazig University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 38 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Laparoscopic Radical Hysterectomy and Open Radical Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cervical Cancer
- Being tested
- Laparoscopic Radical Hysterectomy, Open Radical Hysterectomy
- Keywords
- Radical Hysterectomy, Laparoscopic Surgery, Early-Stage Cervical Cancer, Minimally Invasive Surgery
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Radical HysterectomyProcedure or surgery
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.
Open Radical HysterectomyProcedure or surgery
A standard open abdominal radical hysterectomy includes dissection of the pelvic lymph nodes and the closure of the vaginal stump.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Open Radical Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
The surgery duration will be measured in minutes from skin incision to closure.
Measured: 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.
Measured: Intraoperative period
Length of Hospital Stay
Duration of hospital stay measured in days from surgery to discharge
Measured: Up to 30 days post-surgery
Secondary outcomes (1)
Recurrence Rate
Assessment of cancer recurrence following surgical intervention during the follow-up period.
Measured: Up to 3 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Mar 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ola A Harb, Professor, Study chair, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626996
- Sponsor's protocol ID
- LAPvsOPEN-RH-Study
- Acronym
- LAP-OPEN
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data contains patient information
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Laparoscopic-assisted Hysterectomy Versus Open Radical Hysterectomy in Early-Stage Cervical Cancer: A Comparative Study
- ClinicalTrials.gov ID
- NCT07626996
- Acronym / sponsor ID
- LAP-OPEN / LAPvsOPEN-RH-Study
- Conditions
- Cervical Cancer
- Keywords
- Radical Hysterectomy, Laparoscopic Surgery, Early-Stage Cervical Cancer, Minimally Invasive Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Radical Hysterectomy | Experimental | Procedure: Laparoscopic Radical HysterectomyIn 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 | Procedure: Open Radical HysterectomyUnder conventional surgical techniques in this group , participants underwent open abdominal radical hysterectomy with bilateral adnexectomy and dissection of pelvic lymph nodes. |
Who may qualify
- Ages
- 38 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 (
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Radical HysterectomyIn 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. | Procedure or surgery | Laparoscopic Radical Hysterectomy |
| Open Radical HysterectomyA standard open abdominal radical hysterectomy includes dissection of the pelvic lymph nodes and the closure of the vaginal stump. | Procedure or surgery | Open Radical Hysterectomy |
Primary outcome
Operative Time
Time frame: Intraoperative period (day of surgery)
The surgery duration will be measured in minutes from skin incision to closure.
Intraoperative Blood Loss volume
Time frame: Intraoperative period
Assessment of volume of intraoperative blood loss (mL): Estimated blood loss volume measured in millilitres during surgery.
Length of Hospital Stay
Time frame: Up to 30 days post-surgery
Duration of hospital stay measured in days from surgery to discharge
1 secondary outcome
Recurrence Rate
Time frame: Up to 3 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. Data contains patient information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola A Harb, Professor study chair
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Radical Hysterectomy and Open Radical Hysterectomy in people with Cervical Cancer, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: Intraoperative period (day of surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.