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CompletedNCT04808583Updated Nov 18, 2022

Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy

An interventional study of TLH with uterine artery ligation at its origin at the beginning of the operation and conventional TLH with uterine artery ligation after the cornual pedicles in Uterine Diseases, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
Female
01

Study 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.

Read the detailed description
  1. Approval of the study protocol will be sought from ASUMH ethical committee.
  2. The patients will be enrolled from the outpatient gynecology clinic of ASUMH.
  3. History, examination and routine investigations will be done to identify eligible patients.
  4. Written informed consent will be sought from the patients after proper counseling.
  5. Randomization: It will be a quasi-randomized clinical trial.
  6. 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.
  7. Blinding: the patient will not be aware of the method used (either the conventional method or the At-origin ligation method) (single blinded).
  8. 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).

  9. 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).

  10. 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.
02

Conditions studied

  • Uterine Diseases

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Keywords

  • laparscopic hystrectomy uterine artery operative time
03

In context

Uterine Diseases

66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.

This study's enrollment of 20 is below the median of 98 across 52 interventional studies indexed under Uterine Diseases.

Browse Uterine Diseases studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 )

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Group (A)

    conventional TLH with uterine artery ligation after the cornual pedicles

    Procedure: conventional TLH with uterine artery ligation after the cornual pedicles

  • Experimental
    Group (B)

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

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

Interventions

  • ProcedureTLH with uterine artery ligation at its origin at the beginning of the operation

    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

  • Procedureconventional TLH with uterine artery ligation after the cornual pedicles

    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.

06

What researchers measure

Primary outcomes

  1. Operative time in minutes

    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 outcomes

  1. 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.

    Time frame: Intraoperative (once for each patient at the end of the operation .)

  2. postoperative pain measured using visual analogue score.

    VAS : visual analogue score where (0): no hurt - (10) : Hurts worst

    Time frame: 6 hours postoperative - 12 hours postoperative

  3. Hospital stay (in days)

    hospital stay in days after the procedure .

    Time frame: "through study completion, an average of 1 year".

  4. Complications

    (visceral , bladder or ureteric injuries).

    Time frame: during the procedure,immediately after the procedure .

07

Study locations

1 site
  • Ain shams maternity hospital
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04808583
Lead sponsor
Ain Shams University
Responsible party
Yasser Elrefaey (Assistant Lecturer of obstetrics and gynecology, Ain Shams University) — Principal investigator
First posted
Mar 22, 2021
Start date
Jul 2, 2021
Primary completion
Oct 30, 2022
Completion
Oct 30, 2022
Last update
Nov 18, 2022

Study contacts

Hazem M Sammour, MD
study chair · Professor of Obstetrics and Gynecology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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