TLH With Prior Uterine Artery Clipping at Its Origin Versus Conventional TLH

NCT05028543 | Unknown DMC

• 1 other identifier: New TLH technique
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial was done on 30 women planned for TLH, and divided into two groups; group A includes women that will be subjected to conventional TLH, and group B includes women that will be subjected to TLH with prior uterine artery clipping at its origin. Both grouped will be compared regarding the blood loss, operation time, intraoperative complications and post-operative follow-up

Conditions

Total Laparoscopic Hysterectomy

Keywords

New technique for TLH; Clipping of uterine artery at its origin; Hystrectomy

Outcome Measures

Primary Outcomes (1)

• The total blood loss

  Blood loss (mL): The total blood loss will be from the suction apparatus

  start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars

Secondary Outcomes (1)

• intraoperative or postoperative complications

  during the Laparoscopy and during the hospital stay (24 hours postoperative

Study Arms (2)

conventional TLH

PLACEBO COMPARATOR

women that will be subjected to conventional Total laparoscopic hysterectomy

Procedure: Conventional TLH

TLH with prior uterine artery clipping at its origin

EXPERIMENTAL

women that will be subjected to TLH with prior uterine artery clipping at its origin

Procedure: Clipping of utrine artery at its origin before bginning of TLH

Interventions

Conventional TLH PROCEDURE

Procedure: conventional Total laparoscopic hysterectomy the uterine artery will be identified close to the isthmus then coagulated at this level, close to the uterus , using bipolar diathermy. The utero-vesical fold will be dissected and the bladder will be pushed down done.. The vasculature of the uterus will now secured and this will be evidenced by the pale color of the fundus. Using either bipolar diathermy , the cornual pedicles on one side will be desiccated and cut. Also, both the uterosacral and cardinal ligaments will be coagulated and cut. So that, the opposite side pedicles can be taken care of.. The infundibulopelvic ligaments will be coagulatd and cut if it is necessary to remove both ovaries. A vaginal cuff was inserted into the vagina to identify the vault, which will then cut laparoscopically using a monopolar hook, where the specimen will be completely detached.

conventional TLH

Clipping of utrine artery at its origin before bginning of TLH PROCEDURE

the uterine artery will be dissected using posteriorly and medially to the infundibulopelvic ligament, the ureter should be first identified. The surgeon may grab the obliterated umbilical artery at the anterior abdominal wall and retract it. The movement of the umbilical artery may be Seen at the ovarian fossa perpendicular to the ureter The uterine vessels will be clipped at their origin from the hypogastric vessels using aclip applier which will be introduced through 10mm trocar. clipping of the artery will be performed through application of two 5 mm size metallic clips in continuity and complete the laparoscopic hysterectomy with the same steps of the conventional method.

TLH with prior uterine artery clipping at its origin

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Benign conditions as indications for hysterectomy (e.g., dysfunctional uterine bleeding, adenomyosis and uterine fibroids) provided that the uterus size is no more than 14 weeks.

You may not qualify if:

• Obese patients i.e., BMI \> 35 k.g\\m2.
• Suspected extensive pelvic adhesions based on previous history and examination.
• Factors which may delay vaginal vault healing as uncontrolled diabetes, prolonged corticosteroid therapy or advanced liver diseases.
• Inability to give adequate informed consent to participate in the study.
• Previous ureteric surgery
• Previous midline incision
• Previous uterine artery embolization.
• Known tubo ovarian pathology requiring primary laparotomy, e.g. large adnexal masses.
• Conditions interfering with laparoscopic surgery e.g. significant cardiopulmonary disease.
• Large uterus interfering with TLH (size \>14 gestational weeks).
• Broad ligament and cervical myoma hindering access to the lateral pelvic wall
• Having endometriosis grade III orIV according to ASRM classification.
• Having 2nd or 3rd degree uterine descent

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11865, Egypt

RECRUITING

Related Publications (8)

• Gueli Alletti S, Restaino S, Finelli A, Ronsini C, Lucidi A, Scambia G, Fanfani F. Step by Step Total Laparoscopic Hysterectomy with Uterine Arteries Ligation at the Origin. J Minim Invasive Gynecol. 2020 Jan;27(1):22-23. doi: 10.1016/j.jmig.2019.06.001. Epub 2019 Jun 12.

  PMID: 31201941 BACKGROUND

• BriJtow R:Total Laparoscopic Hystrectomy: Text book of Te Linde's Atlas Operative Gynecology Robert E, Bristow Ricardo Azziz Robert E.Bristo. 10thEdition. (2014b); ch.4: 35-41

  BACKGROUND

• DOS SANTOS MARTIN, R. L.,et al: How do I perform temporary occlusion of the uterine arteries during laparoscopic myomectomy. Gynecol Obstet (Sunnyvale), 2015, 5.278: 2161-0932.1000278.

  BACKGROUND

• Johanson ML, Lieng M. Changes in route of hysterectomy in Norway since introduction of robotic approach. Facts Views Vis Obgyn. 2021 Mar 31;13(1):35-40. doi: 10.52054/FVVO.13.1.005.

  PMID: 33889859 BACKGROUND

• Kale A, Aksu S, Terzi H, Demirayak G, Turkay U, Sendag F. Uterine artery ligation at the beginning of total laparoscopic hysterectomy reduces total blood loss and operation duration. J Obstet Gynaecol. 2015;35(6):612-5. doi: 10.3109/01443615.2014.990431. Epub 2014 Dec 17.

  PMID: 25517762 BACKGROUND

• Popa A, Copaescu C, Horhoianu V. Laparoscopic total hysterectomy still not routinely chosen Operative description and available instruments. J Med Life. 2019 Jul-Sep;12(3):301-307. doi: 10.25122/jml-2019-0051.

  PMID: 31666835 BACKGROUND

• Howard W Jones III MD and J. A. R. M:Te Linde's Operative Gynecology ( 11th Edition) 2015

  BACKGROUND

• Zhao D, Li B, Wang Y, and Liu S, Zhang Yand Zhang G:

  BACKGROUND

Study Officials

• Marwa Elgndi, MD

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

Yasmeen Ahmed taha, Master

CONTACT

01272339254; yasmeenahmedtaha@outlook.com

Marwa mohamd Elgendi, MD

CONTACT

01227563718; M.abdelmawla@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study design precluded neither participants nor the surgeons will be blinded, only data analyzer will be blinded to each allocation group" single blinded study". However, the outcomes of the study are objective not subjective and will not be affected by lack of blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The principal investigator

Model Details: A Randomized controlled Trial.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: August 21, 2021
• Primary Completion: January 30, 2022
• Study Completion: August 21, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)