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NCT Number: NCT07601971

Total Laparoscopic Hysterectomy With Prior Uterine Artery Cauterization From the Origin Versus Conventional Laparoscopic Hysterectomy

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.

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Key information

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1

Procedure

Total Laparoscopic hysterectomy with prior Uterine artery cauterization from the origin to arm 1

Conventional Laparoscopic hysterectomy to arm 2

Procedure

Conventional Laparoscopic hysterectomy

Total Laparoscopic hysterectomy with conventional uterine artery ligation

Procedure

Total Laparoscopic hysterectomy with ligation of uterine artery beside uterus is considered conventional and may cause more blood loss and take more time

Primary outcomes

  1. 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

    Time frame: 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

  2. Is to compare peri operative blood loss , operation time between Conventional TLH and TLH with prior occlusion to UAs at its origin

    Time frame: One week after surgery

    Is to compare peri operative blood loss , operation time between conventional TLH and TLH with prior Uterine artery occlusion

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

    Time frame: 24 hours postoperative

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hadeer Ali Elashry, Master degree

CONTACT

[email protected]

+2 01012402227

Mustafa Farag Ellakany, Lecturer

CONTACT

+2 01016083210

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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