Total Laparoscopic Hysterectomy
Conditions
Brief summary
To evaluate whether routine ureterolysis during Total Laparoscopic Hysterectomy for benign gynecologic conditions affects operative efficiency and perioperative safety compared with a selective ureterolysis approach.
Detailed description
Hysterectomy is one of the most commonly performed major gynecological procedures worldwide, with approximately 600,000 procedures performed annually in the United States alone and similar rates observed globally when adjusted for population size.1 Over the past two decades, there has been a paradigm shift in surgical approach, with minimally invasive techniques, particularly total laparoscopic hysterectomy (TLH), increasingly replacing traditional open surgery.2 This transition has been driven by compelling evidence demonstrating significant advantages of the laparoscopic approach, including reduced postoperative pain, shorter hospital stays, faster return to normal activities, improved cosmetic outcomes, and lower overall morbidity compared to abdominal hysterectomy.2 Ureteric injury represents one of the most serious potential complications during TLH which occurs in 0.2 to 6 % of cases due to the close anatomical relation with the ureter, which is higher than abdominal hysterectomy in which ureteric injury occurs in 0.03 to 2 % of cases.3 Ureteric injury has potentially devastating consequences for patients including renal impairment, prolonged hospitalization, need for additional surgical interventions, and long-term morbidity.4 Ureterolysis during TLH helps to reduce the incidence of ureteric injury.5 Ureterolysis is infrequently practiced by gynecologists however, it is necessary during complex surgery.6 The American Association of Gynecologic Laparoscopists (AAGL) practice guidelines for laparoscopic hysterectomy state that "identification of the ureters should be undertaken when the anatomy is unclear or when risk factors for injury are present," but acknowledge that "some surgeons advocate routine ureterolysis for all laparoscopic hysterectomies.7 Surgeons who perform ureterolysis as a routine approach justify it due to : 1. The additional operative time (10-15 minutes) is justified by improved safety.8 2. When performed correctly, ureterolysis does not significantly increase risk of direct injury.8 3. The technique preserves periureteric blood supply when proper tissue planes are followed.8 4. Routine practice ensures surgical proficiency.8 5. Patient outcomes are improved when injuries are prevented rather than managed after they occur.8 In this study we aim to compare between routine approach and selective approach for ureterolysis during laparoscopic hysterectomy
Interventions
PROCEDURERoutine Ureterolysis
for all cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record.
PROCEDURESelective Ureterolysis
for selected cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record.
Sponsors
ClinAmygate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and postoperative outcome assessors will be blinded to treatment allocation. Because of the nature of the surgical interventions, the operating surgeons cannot be blinded. Data analysts will remain blinded to group allocation, with the intervention groups coded and their identities concealed until the primary analysis has been completed.
Intervention model description
Randomized controlled parallel study
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Women aged 35-70 years Scheduled for TLH for benign indications: Symptomatic fibroids, Abnormal uterine bleeding, Adenomyosis, Endometrial hyperplasia, Pelvic organ prolapse requiring hysterectomy, Chronic pelvic pain, Uterine size ≤16 weeks
Exclusion criteria
* Previous pelvic radiation * Known ureteric abnormalities or pathology * Severe cardiopulmonary disease precluding laparoscopy * Inability to provide informed consent * Known retroperitoneal pathology * Emergency surgery * Uterine size \> 16 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total operative duration | day 0 | Total operative duration in minutes measured from skin incision to skin closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time needed for ureterolysis | day 0 | Determine time needed for ureterolysis during TLH |
Countries
Egypt
Contacts
CONTACTMostfa MA Saad, MSc
Outcome results
None listed