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

NCT ID: NCT04894552

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-12-31

Brief Summary

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.

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.

Conditions

Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy for Endometrial Carcinoma

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Ahmed Magdy Abdelmonem Hussein Alzeiny

The principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Elsenity, Prof.

Role: STUDY_DIRECTOR

Ain Shams Maternity Hospital

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammad Alzeiny, Master

Role: CONTACT

mohammadalzeiny@yahoo.com

01001539675

Mohamed Elsenity, Prof.

Role: CONTACT

mohamedelsenity@med.asu.edu.eg

01226573332

Facility Contacts

Mohammad Alzeiny, Master

Role: primary

mohammadalzeiny@yahoo.com

01001539675

Mohamed Elsenity, Prof.

Role: backup

mohamedelsenity@med.asu.edu.eg

01226573332

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Other Identifiers

Hysterectomy and Sentinel LN

Identifier Type: -

Identifier Source: org_study_id