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Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy

Primary Purpose

Uterine Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TLH with uterine artery ligation at its origin at the beginning of the operation
conventional TLH with uterine artery ligation after the cornual pedicles
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Diseases focused on measuring laparscopic hystrectomy uterine artery operative time

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age group (35-70 years old).
  2. Women consenting to have a total laparoscopic hysterectomy.

Exclusion Criteria:

  1. Patients with relative contraindication to general anesthesia (e.g. chronic liver cell failure)(All laparoscopic procedures are done under GA).
  2. Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary dysfunction).
  3. Bleeding tendency (e.g. anticoagulants, platelets disorders)(will affect the blood loss measurement)
  4. Body mass index more than 35 Kg/m2(not suitable for laparoscopic surgeries as obesity affects airway pressure )
  5. Uncorrected anemic patients (Hemoglobin < 10 gm. /dl).(will affect the outcomes eg :

Blood transfusion , hospital stay … etc )

Sites / Locations

  • Ain shams maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group (A)

Group (B)

Arm Description

conventional TLH with uterine artery ligation after the cornual pedicles

TLH with uterine artery ligation at its origin at the beginning of the operation

Outcomes

Primary Outcome Measures

Operative time in minutes
starting from port insertion till disconnecting the uterus from the vagina

Secondary Outcome Measures

Blood loss in millimeters
blood loss in the operation will be measured from the suction apparatus keeping in mind the amount of fluid used during irrigation.
postoperative pain measured using visual analogue score.
VAS : visual analogue score where (0): no hurt - (10) : Hurts worst
Hospital stay (in days)
hospital stay in days after the procedure .
Complications
(visceral , bladder or ureteric injuries).

Full Information

First Posted
February 22, 2021
Last Updated
November 16, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04808583
Brief Title
Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy
Official Title
Efficacy of At-origin Uterine Artery Ligation Compared to Conventional Post-cornual Pedicle Ligation in Reducing Operative Time During Total Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the current study is to compare between the uterine artery ligation at its origin at the beginning of the operation and the conventional method after cornual pedicle regarding their efficacy to minimize operative time in patients undergoing total laparoscopic hysterectomy.
Detailed Description
Approval of the study protocol will be sought from ASUMH ethical committee. The patients will be enrolled from the outpatient gynecology clinic of ASUMH. History, examination and routine investigations will be done to identify eligible patients. Written informed consent will be sought from the patients after proper counseling. Randomization: It will be a quasi-randomized clinical trial. Allocation: through "Alternation" method. Eligible patients will be randomized into one of the two study groups, where odd numbered patients (ex: patient number 1, 3, 5, etc. …) will be allocated to group (A) and even numbered patients (ex: patient number 2, 4, 6, etc. …) will be allocated to group (B) till full-filing the sample size. Before the operation, the patient will be allocated according to her number. Blinding: the patient will not be aware of the method used (either the conventional method or the At-origin ligation method) (single blinded). Patients who are randomized to group A will undergo TLH in the conventional method as follows: Positioning:The patient will be positioned in dorsal decubitus, under general anesthesia, with oral tracheal intubation. The legs will be positioned in 30°flexion; the arms along the body, and the buttocks extending slightly over the edge of the surgical table. The bladder will be catheterized. The surgeon will be positioned to the left of the patient, the primary assistant on the right, and the second assistant is responsible for uterine manipulation. Uterine Cannulation: Uterine cannulation will be performed using uterine manipulator. Hysterometry will be performed, the cervix will be dilated using Hegar dilators if needed, and the manipulator will be inserted under direct vision into the cervix. A Veress needle will be inserted at the umbilicus or supraumbilical site depending on the size of the uterus and abdomen will be insufflated with carbon dioxide at initial pressure of 20 mm Hg and maintenance at 15 mm Hg. A 10 mm trocar will be inserted blindly, and 10 mm telescope will be introduced through this port. Uterus and the adnexa will be visualized. Three additional 5mm ports are introduced: one along the left spino-umbilical line at the junction of medial 2/3rd and lateral 1/3rd, second port at right angles to the previous port, and a third 5 mm port placed around 2 cm below and to the right of umbilicus. The entire abdomen is surveyed before starting the procedure. The size of the uterus, presence of myomas, and adnexa and course of ureters are visualized (Poojari et al., 2014). Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014). Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides. Vault will be cut laparoscopically using monopolar hook and the specimen will be detached completely. The uterus with cervix will be delivered vaginally. The vaginal vault will then be sutured with number 0 delayed absorbable suture (vicryl). While patients randomized to group B will undergo TLH as follows: After insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery. Dissecting the utero-vesical fold and pushing the bladder down will move the ureters laterally and decrease the risk of injuring them. The vasculature of the uterus will thus be secured, and this will be evidenced by the color change in the fundus, which will become pale. The cornual pedicles on one side (including the round ligament and either the utero-ovarian or infundibulopelvic ligments ) will then be desiccated and cut using the ligasure. The coagulated uterine pedicles will be cut. The utero-sacral and cardinal ligaments will be desiccated and cut. Then the opposite side pedicles will be taken care of. (Poojari et al., 2014). The operative time will be calculated and the total blood loss will be measured from the suction apparatus keeping in mind the amount of fluid used during irrigation. The urinary catheter will be removed after 6 hours and liquid diet will be started after peristalsis is established as evidenced by audible intestinal sounds. Follow up vital data and postoperative pain by visual analogue score and measuring postoperative hemoglobin, the patient will be discharged the following day and called for follow-up after 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Diseases
Keywords
laparscopic hystrectomy uterine artery operative time

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Active Comparator
Arm Description
conventional TLH with uterine artery ligation after the cornual pedicles
Arm Title
Group (B)
Arm Type
Experimental
Arm Description
TLH with uterine artery ligation at its origin at the beginning of the operation
Intervention Type
Procedure
Intervention Name(s)
TLH with uterine artery ligation at its origin at the beginning of the operation
Intervention Description
After insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery
Intervention Type
Procedure
Intervention Name(s)
conventional TLH with uterine artery ligation after the cornual pedicles
Intervention Description
Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014). Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides.
Primary Outcome Measure Information:
Title
Operative time in minutes
Description
starting from port insertion till disconnecting the uterus from the vagina
Time Frame
Intraoperative (once for each patient starting from port insertion till disconnecting the uterus from the vagina .)
Secondary Outcome Measure Information:
Title
Blood loss in millimeters
Description
blood loss in the operation will be measured from the suction apparatus keeping in mind the amount of fluid used during irrigation.
Time Frame
Intraoperative (once for each patient at the end of the operation .)
Title
postoperative pain measured using visual analogue score.
Description
VAS : visual analogue score where (0): no hurt - (10) : Hurts worst
Time Frame
6 hours postoperative - 12 hours postoperative
Title
Hospital stay (in days)
Description
hospital stay in days after the procedure .
Time Frame
"through study completion, an average of 1 year".
Title
Complications
Description
(visceral , bladder or ureteric injuries).
Time Frame
during the procedure,immediately after the procedure .

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group (35-70 years old). Women consenting to have a total laparoscopic hysterectomy. Exclusion Criteria: Patients with relative contraindication to general anesthesia (e.g. chronic liver cell failure)(All laparoscopic procedures are done under GA). Patients with contraindication to laparoscopic surgery (e.g. severe cardio-pulmonary dysfunction). Bleeding tendency (e.g. anticoagulants, platelets disorders)(will affect the blood loss measurement) Body mass index more than 35 Kg/m2(not suitable for laparoscopic surgeries as obesity affects airway pressure ) Uncorrected anemic patients (Hemoglobin < 10 gm. /dl).(will affect the outcomes eg : Blood transfusion , hospital stay … etc )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem M Sammour, MD
Organizational Affiliation
Professor of Obstetrics and Gynecology
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams maternity hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy

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