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Total Laparoscopic HysterectomyTLHNCT05028543

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

A study testing Conventional TLH and Clipping of utrine artery at its origin before bginning of TLH in people with Total Laparoscopic Hysterectomy, run by Ain Shams Maternity Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Total Laparoscopic Hysterectomy
What is being tested?
Conventional TLH and Clipping of utrine artery at its origin before bginning of TLH
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteEgypt
Study dates
21 Aug 2021to 21 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • 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.

Who cannot join

  • • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Yasmeen Ahmed taha, Master contact

01272339254

yasmeenahmedtaha@outlook.com

Marwa mohamd Elgendi, MD contact

01227563718

M.abdelmawla@yahoo.com

Egypt1 site, 1 recruiting
  • Ain Shams University Maternity Hospital

    Cairo, 11865

    yasmeen taha, master, 01272339254, yasmeenahmedtaha@outlook.com

    marwa Elgendi, MD, 01227563718, M.abdelmawla@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Total Laparoscopic Hysterectomy(TLH) With Prior Uterine Artery Clipping Versus Conventional Total Laparoscopic Hysterectomy

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

Read the detailed description

Patients will be randomized into 2 groups:

Group (A): Women who will be subjected to conventional Total laparoscopic hysterectomy Group (B): Women who will be subjected to Total laparoscopic hysterectomy with prior uterine artery clipping at its origin.

Intraoperative:

Pre-Anesthesia medications: All patients will receive intravenous antibiotics 30 minutes before induction of anesthesia {Cefotaxime 1gm (Claforan®-EIPICO) \& Metronidazole 500 mg (Flagyl®-rPr)}.

  • All patients will be positioned in the dorsal lithotomy position
  • Examination under anesthesia will be done to assess uterine size, mobility and the presence of any gross adnexal pathology.
  • A bladder catheter will be placed to empty the bladder and to monitor the urine output.
  • A uterine manipulator (V care cup®) will be placed through the cervix to manipulate the uterus.
  • The surgeon will stay on the left side of the patient, the assistant on the right side and the scrub nurse in between the patient's legs for uterine manipulation.
  • A small vertical incision will be made into the depth of the supra umbilicus about 0.5 cm length;
  • The closed method will be employed where the Veress needle will be inserted vertically into the supra -umbilical incision.
  • Hanging drop test will be done to ensure proper needle placement through attaching an open syringe filled with saline to the Veress needle and observing the drop.
  • Insertion of 10 mm trocar through the supra umbilical incision and then the operating laparoscope will be inserted through the supra umbilical port.
  • CO2 Insufflation will be started to induce pneumoperitoneum till pressure reached 20 mmHg and reduced to 15 mm afterwards.
  • Two 5 mm lower quadrant ancillary trocars will be inserted lateral to the inferior epigastric arteries under direct laparoscopic vision above the pubic hairline.
  • Another 10 mm trocar will be inserted 3cm above the left lower ancillary trocar under direct vision.

Technical aspects After a thoroughly exploration of the pelvic cavity, the entire abdomen will be surveyed before starting the procedure.

The size of the uterus, presence of myomas, and adnexa and course of ureters will be visualized.

  1. In conventional TLH (control group) :The following will be done 1. -Round ligaments will be coagulated and cut. 2. -Separation of the adnexal structures from the uterine corpus for subsequent preservation or removal:
  2. For salpingo-oophorectomy: the infundibulopelvic ligament will be placed on contralateral traction, awindow will be created in the medial leaf of the broad ligament below the ovarian vessels and ventral to the ureter, maintaining direct visualization of the ureter.The infundibulopelvic ligament will be coagulated and divided.
  3. If preservation of the adnexa will be planned:The fallopian tube and utero-ovarian ligament will be coagulated close to the uterine fundus and detached. The medial leaf of the broad ligament can be incised down to a level just ventral to the pelvic ureter to allow the adnexa to drop out of the field of dissection. The procedure will be repeated on the contralateral side 3. -Dissecting, occluding, and dividing the blood supply prior to extirpation of the uterine corpus:(skeletonization of the uterine vessels at uterine isthmus, coagulation of the vessels, after identification of the ureter) 4. Transection of the cardinal ligament complex with colpotomy and amputation of the cervix from the vaginal apex.
  4. Removing the specimen. 6. Laparoscopic closure of the vaginal cuff.
  5. In intervention group:

The same steps as in control group but with extra step after coagulation and cutting of the round ligaments. The following steps will be done to reach to the origin of uterine artery from internal iliac artery :

Posterior and medial 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 peritoneum of the ovarian fossa should be opened above the ureter and over the impression of the umbilical artery. The ureter will be retracted medially and the umbilical artery will be dissected vertical and cranially. Usually, one will identify the origin of the uterine artery at this point, which goes medial to the umbilical artery and almost parallel 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

Postoperative care:

  1. The patient will receive IV fluids in the first 24hours (3litres).
  2. Oral clear fluid intake will be started 8 hours after the operation.
  3. Another dose of antibiotics will be received 6hrs after the operation with the same regimen used in induction.
  4. Postoperative analgesia (NSIDS ®)
  5. The urinary catheter will be removed after 24hrs after the operation.
  6. CBC will be withdrawn 24hrs after the operation.
  7. Histopathological examination of the specimen will be done.
  8. Vaginal douches and coital activity will be advised against for 3 monthes
Being tested
Conventional TLH, Clipping of utrine artery at its origin before bginning of TLH
Keywords
New technique for TLH, Clipping of uterine artery at its origin, Hystrectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional TLHProcedure or surgery

    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.

  • Clipping of utrine artery at its origin before bginning of TLHProcedure or surgery

    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.

Study groups in NCT05028543
Study groupRoleWhat they receive
conventional TLHPlacebo comparatorwomen that will be subjected to conventional Total laparoscopic hysterectomy
Receives: Procedure: Conventional TLH
TLH with prior uterine artery clipping at its originExperimentalwomen that will be subjected to TLH with prior uterine artery clipping at its origin
Receives: Procedure: Clipping of utrine artery at its origin before bginning of TLH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The total blood loss

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

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

Secondary outcomes (1)
  1. intraoperative or postoperative complications

    intraoperative complications are that during the Laparoscopy postoperative complications are that during the hospital stay (24 hours postoperative)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start21 Aug 2021
  3. Primary completion30 Jan 2022 (estimated)
  4. Study completion21 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Randomized controlled Trial.
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028543
Sponsor's protocol ID
New TLH technique
Acronym
TLH
Status last verified
Aug 2021
First submitted
25 Aug 2021
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31201941
  • 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

  • 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.

  • 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.

    PubMed 33889859
  • 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.

    PubMed 25517762
  • 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.

    PubMed 31666835
  • Howard W Jones III MD and J. A. R. M:Te Linde's Operative Gynecology ( 11th Edition) 2015

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

Questions about this trial

What is this clinical trial studying?

A study testing Conventional TLH and Clipping of utrine artery at its origin before bginning of TLH in people with Total Laparoscopic Hysterectomy, run by Ain Shams Maternity Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yasmeen Ahmed taha, Master (01272339254, yasmeenahmedtaha@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The total blood loss (time frame: start time is the insertion of 10 mm telescope trocar end-time is the removal of all trocars). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05028543, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.

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