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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
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)}.
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.
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:
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.
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.
5. Removing the specimen. 6. Laparoscopic closure of the vaginal cuff.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional TLH | Placebo Comparator | women that will be subjected to conventional Total laparoscopic hysterectomy |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative or postoperative complications | intraoperative complications are that during the Laparoscopy postoperative complications are that during the hospital stay (24 hours postoperative) | during the Laparoscopy and during the hospital stay (24 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
• Obese patients i.e., BMI > 35 k.g\m2.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmeen Ahmed taha, Master | Contact | 01272339254 | yasmeenahmedtaha@outlook.com | |
| Marwa mohamd Elgendi, MD | Contact | 01227563718 | M.abdelmawla@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Marwa Elgndi, MD | Ain Shams Maternity Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Recruiting | Cairo | 11865 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31201941 | Background | 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. | |
| 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. | ||
| 33889859 |
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A Randomized controlled Trial.
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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.
|
| 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. |
|
| 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. |
| 25517762 | 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. |
| 31666835 | 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. |
| 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: |