- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07601971
Total Laparoscopic Hysterectomy With Prior Uterine Artery Cauterization From the Origin Versus Conventional Laparoscopic Hysterectomy
Přehled studie
Postavení
Podmínky
Detailní popis
The most common non-pregnancy-related gynecological procedure performed for women is a hysterectomy. (Uwais et al,. 2024 )In Germany, the incidence of hysterectomy ranges from 2.13 to 3.62/1000, while in the United States, it is 5.4/1000. In the US, about 600,000 hysterectomy surgeries are carried out each year. (Harvey et al ,. 2022 ) Fibroids, adenomyosis, endometriosis, dysfunctional uterine bleeding, uterine prolapse, and premalignant and malignant lesions are among the many indications for a hysterectomy. (Singh et al ,. 2024 ) Traditionally , hysterectomy has been done abdominally or by vaginal route . In the present era , Laparoscopic hysterectomy has recently received a considerable respect as a favourable hysterectomy technique . ( Bartels et al ,. 2020 ) Laparoscopic hysterectomy is a safe , workable technique , provides minimal post operative discomfort, shorter hospital stay , rapid convalescence , early return to daily activities. ( Pepin , K. et al ., 2020 ).
Selection of route of hysterectomy can be influenced by size , shape of the vagina and uterus, accessibility of the uterus, extent of extra uterine disease , surgeon experience, available hospital support, whether the case is emergent or scheduled and preference of the informed patient . ( Panda et al ,. 2022 )
.As Laparoscopic surgery becomes more advanced and widely applied, the absolute contraindications to laparoscopy are diminishing . Patient limitations to Laparoscopic surgery can be both anatomical and physiological .
Adverse anatomical limitations include difficult access to the abdomen , obliteration of the peritoneal space , organomegaly , intestinal distension and the potential for cancer dissemination.
The major physiological obstacles to safe Laparoscopy include increased intracranial pressure, abnormalities in cardiac output and gas exchange in the lung , chronic liver disease and coagulopathy . These anatomical and physiological conditions were formerly considered absolute contraindications to laparoscopy, they are now considered only relative contraindications.( Madhok et al ,. 2022 )
. The uterus receives the majority of its blood supply from the uterine artery, a branch of the internal iliac artery. In order to reach the uterine cervix, the uterine artery is first found 2.5 cm lateral and superior to the ureter before crossing it anteriorly to its medial side .( Selcuk I et al ,. 2018).
The ureter is more susceptible to injury during oophorectomy and hysterectomy because of its close relationship to the ovary, where it lies beneath the insertion of the infundibulopelvic ligament at the pelvic brim, and its relationship to the uterine artery, where it passes inferior to the uterine artery.( Lescay et al ,. 2024 )
Although total Laparoscopic hysterectomy (TLH ) is generally safe .There is a potential risk of complications may occur . Excessive blood loss during TLH is still an issue which need blood transfusion especially in case of large uteri . ( Saad _ Naguib M et al , .2022) .
During TLH, the uterine arteries (UAs) must be closed effectively.Closing UAs at the uterine level or at the origin from the internal iliac artery are the two main options . The decision is solely based on the preferences and opinions of the surgeon.( Uccella et al ,. 2021) .
There is a shortage in data that compare two techniques , therefore , Current study will be conducted to compare feasibility, duration of the surgery , estimated blood loss , post operative complications during conventional Laparoscopic hysterectomy versus early Uterine artery cauterization at its origin .
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hadeer Ali Elashry, Master degree
- Telefonní číslo: +2 01012402227
- E-mail: hadeer.alashry1997@gmail.com
Studijní záloha kontaktů
- Jméno: Mustafa Farag Ellakany, Lecturer
- Telefonní číslo: +2 01016083210
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria: Age of the patient is more than 35 y . Non malignant pathologies including fibroids, endometrial hyperplasia, Dysfunctional Uterine bleeding not responding to medical treatment.
Good general condition of the patient ( American society of Anesthesiologists "ASA" score 1 , 2 , 3 ( Horvath et al ,. 2021) .
Uterine size is less than 20 weeks by fundal level . -
Exclusion Criteria:Age of the patient is less than 35 y . Gynecological malignancies . Contraindications for laparoscopy as any medical condition worsens by peumo peritoneum or Trendelenburg position as severely compromised cardiopulmonary status .
Patients with American society of Anesthesiologists score 4 or more . ( Horvath et al ,. 2021) Uterine size is more than 20 weeks by fundal level .
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Total Laparoscopic hysterectomy with prior uterine artery cauterization from the origin
Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin take less time and cause less bleeding
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Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1
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Experimentální: Conventional Total Laparoscopic hysterectomy
Conventional Total Laparoscopic hysterectomy may cause more blood loss and take more time
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Conventional Laparoscopic hysterectomy
Total Laparoscopic hysterectomy with ligation of uterine artery beside uterus is considered conventional and may cause more blood loss and take more time
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Is to compare peri operative blood loss by counting amount of blood in ml drained by suction , operation time between Conventional TLH and TLH with prior occlusion to UAs at its origin
Časové okno: 24 hours after surgery
|
Is to compare peri operative blood loss by counting amount of blood in ml drained by suction , operation time between Conventional TLH and TLH with prior occlusion to UAs at its origin
|
24 hours after surgery
|
|
Is to compare peri operative blood loss , operation time between Conventional TLH and TLH with prior occlusion to UAs at its origin
Časové okno: One week after surgery
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Is to compare peri operative blood loss , operation time between conventional TLH and TLH with prior Uterine artery occlusion
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One week after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Post operative pain , difference in Hemoglobin level in mg /dl pre and post operative, frequency of post operative hematoma in cm detected by us at vaginal vault and ureteric complications
Časové okno: 24 hours postoperative
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Post operative pain , difference in Hemoglobin level in mg / dl pre and post operative, frequency of post operative hematoma in cm detected by us at vaginal vault and ureteric complications
|
24 hours postoperative
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Total Laparoscopic hysterectom
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