Complications of Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy for Endometrial Carcinoma

May 19, 2021 updated by: Mohammad Ahmed Magdy Abdelmonem Hussein Alzeiny, Ain Shams Maternity Hospital
Endometrial adenocarcinoma is believed to be a more treatable malignancy. Poor prognosis is associated with age, grade and depth of myometrial invasion, lymph node status, tumor size, invasion of lymphovascular space and involvement of the lower uterine segment. Sentinel lymph node (SLN) mapping can be considered as an al¬ternative to standard lymphadenectomy in the patients with apparently uterine-confined disease and to assess whether they have metastatic pelvic lymph nodes. Randomized trials, a Cochrane Database Systematic Review, and population-based surgical studies support minimally invasive techniques due to a lower rate of surgical site infection, ve¬nous thromboembolism, reduced hospitalisation, and lower cost of care. This is a one arm clinical trial pilot study that focuses on the intraoperative and early postoperative complications of laparoscopic hysterectomy in patients with endometrial carcinoma and assess the feasibility and the diagnostic reliability of sentinel lymph node biopsy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with endometrial carcinoma will undergo laparoscopic hysterectomy and sentinel lymph node biopsy. The patient will be put under general anesthesia with endotracheal intubation. The patient will be positioned in a modified lithotomy position with the hips flexed 30 degrees. Patients will lie with legs open and slightly bent, with the buttocks protruding over the edge of the table. The patients' arms will be tucked at her sides. A Foley urinary catheter will be placed and Blue dye is injected at the cervix (2 ml at 3 o'clock and 2 ml at 9 o'clock (1 ml of the dye is injected deep and 1 ml is injected superficially)) and a uterine manipulator will be placed. The patient will be placed in the Trendlenburg position, and then pneumoperitoneum will be achieved through a Veress needle. Then four ports will be introduced (One 10 mm port at the umbilical incision, two 5 mm ports 4 cm medial and slightly above the level of the anterior superior iliac spines, and a 10 mm one midway between the umbilicus and the symphysis pubis). Blood vessels including the ovarian vessels and the uterine artery will be controlled by laparoscopic coagulating shears. After bowel manipulation out of the pelvis, the round ligament will be transected, and then the peritoneum over the psoas muscle will be cut lateral to the infundibulopelvic ligament, which will be retracted medially to permit identification of the iliac vessels and the ureter. The course of each pelvic ureter will be visualized through the medial leaf of the broad ligament. With medial traction on the utero-ovarian ligament or ovary, the peritoneal incision will be extended lateral to the ovarian vessels above the level of the pelvic brim to expose the area for lymphadenectomy. Sentinel lymph nodes will be detected, dissected and isolated. Then standard lymphadenectomy will be done. Then the infundibulopelvic ligament will be transected, care will be taken to ensure that the ureter will be secured. The anterior leaf of the broad ligament and anterior peritoneal reflection of the uterus will be opened. The bladder will be reflected anteriorly with atraumatic forceps introduced through the suprapubic sheath, and the bladder will be dissected from the cervix. Attention and care will be then directed to controlling the uterine artery lateral to the cervix. Care will be taken not to injury the ureter at this point. Ligation of the uterine artery and vein at their origin is preferred. The cardinal ligaments will be transected, and the anterior and posterior vaginal fornices will be opened laparoscopically and will be connected on both sides using the coagulation hook. The whole specimen will be removed through the vagina. The vaginal cuff will be then closed trans-vaginally by Vicryl sutures. Then the peritoneal cavity will be insufflated again and the laparoscope will be re-inserted to check for hemostasis before closure. Laparoscopic exit will be done after lavaging the operative field. Intraoperative and early postoperative complications will be assessed. The isolated sentinel lymph node will be sent for pathological study as well as the standard lymphadenectomy specimens. Both specimens will be compared to assess the diagnostic reliability and sensitivity of the sentinel lymph node.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11865
        • Recruiting
        • Ain Shams University Maternity Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amr Elshalakany, Prof.
        • Principal Investigator:
          • Mohammad Alzeiny, Master
        • Principal Investigator:
          • Ahmed Hamdy, MD
        • Principal Investigator:
          • Adel Shafik, MD
        • Principal Investigator:
          • mohamed elsenity, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients who have endometrial carcinoma and undergoing laparoscopic hysterectomy
  • Estimated uterine upper margin is not beyond the midpoint between the umbilicus and the symphysis pubis.
  • No preexisting cardiopulmonary dysfunction or poor control of systemic diseases.
  • Bimanual pelvic examination confirmed good mobility of an enlarged uterus.
  • Fractional curettage revealed no tumor extension in the endocervical canal.
  • Preoperative metastatic work up revealed no extra-uterine disease either regional or systemic.

Exclusion Criteria:

  • Patient refusal.
  • Estimated uterine upper margin is beyond the midpoint between the umbilicus and the symphysis pubis.
  • Cardiopulmonary dysfunction or poor control of systemic diseases.
  • Bimanual pelvic examination confirmed fixed enlarged uterus.
  • Fractional curettage revealed tumor extension in the endocervical canal.
  • Preoperative metastatic work up revealed extra-uterine disease either regional or systemic.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One arm clinical trial
Convenience sampling method in which the first twenty cases of endometrial carcinoma patients who will undergo laparoscopic hysterectomy will be included. All cases will undergo laparoscopic hysterectomy. Sentinel lymph node biopsy will be detected, dissected and isolated. Then standard lymphadenectomy will be done
Procedure: Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy for Endometrial Carcinoma
Patients with endometrial carcinoma will undergo laparoscopic hysterectomy and sentinel lymph node biopsy. The patient will be positioned in a modified lithotomy position with the hips flexed 30 degrees. Blue dye is injected at the cervix. The round ligament will be transected. Sentinel lymph nodes will be detected, dissected and isolated. Then standard lymphadenectomy will be done. Then the infundibulopelvic ligament will be transected. Ligation of the uterine vessels. The cardinal ligaments will be transected, and the vaginal fornices will be opened laparoscopically. The whole specimen will be removed through the vagina. The vaginal cuff will be then closed trans-vaginally. Intraoperative and early postoperative complications will be assessed. The isolated sentinel lymph node will be sent for pathological study as well as the standard lymphadenectomy specimens. Both specimens will be compared to assess the diagnostic reliability and sensitivity of the sentinel lymph node.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complications of laparoscopic hysterectomy in patients with endometrial carcinoma
Time Frame: one week
To assess the intraoperative and early postoperative complications of laparoscopic hysterectomy in patients with endometrial carcinoma
one week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sentinel lymph node biopsy operative time
Time Frame: one day
The operative time for the sentinel lymph node biopsy and the operative time for the standard lymph adenectomy will be recorded and compared
one day
Diagnostic reliability of sentinel lymph node biopsy in comparison to standard lymphadenectomy
Time Frame: one week
Compare the histopathology reports of the sentinel lymph node biopsy and the standard lymphadenectomy as regards detection of malignant cells and record the number of times the sentinel lymph node biopsy missed the detetcion of malignant cells as compared to the standard lymphadenectomy
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams Maternity Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohamed Elsenity, Prof., Ain Shams Maternity Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hysterectomy and Sentinel LN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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