Laparoscopic HysterectomyNCT07601971
Total Laparoscopic Hysterectomy With Prior Uterine Artery Cauterization From the Origin Versus Conventional Laparoscopic Hysterectomy
A study testing Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1, Conventional Laparoscopic hysterectomy to arm 2 and Total Laparoscopic hysterectomy with conventional uterine artery ligation in people with Laparoscopic Hysterectomy, run by Kafrelsheikh University.
Trial summary
The main goal of this study is to compare between total Laparoscopic hysterectomy proceeded by Uterine artery cauterization at its origin and conventional total Laparoscopic hysterectomy regarding: bleeding , operative time , intra operative time and follow up post operative. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1, Conventional Laparoscopic hysterectomy to arm 2 and Total Laparoscopic hysterectomy with conventional uterine artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 15 Jun 2027
- Phase
- Interventional
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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
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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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mustafa Farag Ellakany, Lecturer contact
About this study
The main goal of this study is to compare between total Laparoscopic hysterectomy proceeded by Uterine artery cauterization at its origin and conventional total Laparoscopic hysterectomy regarding: bleeding , operative time , intra operative time and follow up post operative.
Read the detailed description
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 .
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1, Conventional Laparoscopic hysterectomy to arm 2, Total Laparoscopic hysterectomy with conventional uterine artery ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1Procedure or surgery
Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1
Conventional Laparoscopic hysterectomy to arm 2Procedure or surgery
Conventional Laparoscopic hysterectomy
Total Laparoscopic hysterectomy with conventional uterine artery ligationProcedure or surgery
Total Laparoscopic hysterectomy with ligation of uterine artery beside uterus is considered conventional and may cause more blood loss and take more time
| Study group | Role | What they receive |
|---|---|---|
| Total Laparoscopic hysterectomy with prior uterine artery cauterization from the origin | Experimental | Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin take less time and cause less bleeding Receives: Procedure: Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1 |
| Conventional Total Laparoscopic hysterectomy | Experimental | Conventional Total Laparoscopic hysterectomy may cause more blood loss and take more time Receives: Procedure: Conventional Laparoscopic hysterectomy to arm 2; Procedure: Total Laparoscopic hysterectomy with conventional uterine artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 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
Is to compare peri operative blood loss , operation time between conventional TLH and TLH with prior Uterine artery occlusion
Measured: One week after surgery
Secondary outcomes (1)
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
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
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 May 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Ali Alashry Mohamed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601971
- Sponsor's protocol ID
- Total Laparoscopic hysterectom
- Status last verified
- May 2026
- First submitted
- 9 Jul 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No