Uterine Artery Ligation at Origin in Total Laparscopic Hystrectomy
Condition: Uterine Diseases
MeSH terms: Uterine Diseases
Study type: Interventional

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: 
      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.
    

Intervention name(s): TLH with uterine artery ligation at its origin at the beginning of the operation; conventional TLH with uterine artery ligation after the cornual pedicles
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparscopic hystrectomy uterine artery operative time