To hear about similar clinical trials, please enter your email below
Trial Title:
Comparing the Efficacy of TU-LESS and VNOTES for Hysterectomy of Enlarged Uterus
NCT ID:
NCT06663553
Condition:
Enlarged Uterus
Adenomyosis
Uterine Fibroids (UF)
Conditions: Official terms:
Leiomyoma
Adenomyosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Patients will remain blinded to their surgical methods in 24 hours following the
operation. To achieve this, we will apply wound pads to each patient's abdomen as the
wounds typically seen in tradi tional laparoscopy procedures, no matter whether actual
wounds exist.
Intervention:
Intervention type:
Procedure
Intervention name:
TU-LESS
Description:
patients in TU-LESS group will receive transumbilical laparoendoscopic single-site
surgery (TU-LESS) for hysterectomy
Arm group label:
TU-LESS for hysterectomy
Intervention type:
Procedure
Intervention name:
vNOTES
Description:
patients in vNOTES group will receive transvaginal natural orifice transluminal
endoscopic surgery (TU-LESS) for hysterectomy
Arm group label:
vNOTES for hysterectomy
Summary:
Enlarged uterus is frequently encountered in clinical practice, and its incidence due to
conditions such as adenomyosis, uterine fibroids, and other gynecological disorders has
steadily increased over the years statistically. For example, greater healthcare
awareness has led to more frequent early diagnoses of these conditions, contributing to
the observed rise in incidence. Additionally, increasing life expectancy results in more
women reaching the perimenopausal and postmenopausal stages, during which conditions like
uterine fibroids and adenomyosis become more prevalent. For these women, hysterectomy
(removal of the entire uterus) is often the recommended option of treatment.
With advances in surgical techniques over recent decades, there has been a notable shift
from traditional open abdominal surgeries to minimally invasive approaches. Laparoscopic
surgery has been widely adopted, significantly reducing the size and number of incisions
required, thereby promoting faster recovery, minimizing postoperative pain, and reducing
the risk of complications.
However, conventional multi-port laparoscopic hysterectomy still presents certain
challenges, such as large uterus extraction following resection, and concerns about
healing of incisions. In contrast, innovative techniques like Transumbilical
Laparoendoscopic Single-Site Surgery(TU-LESS) and Transvaginal Natural Orifice
Transluminal Endoscopic Surgery(vNOTES) both take advantage of natural anatomical
openings to achieve minimal or no visible scarring. Studies demonstrate that these
techniques provide superior outcomes in terms of reduced pain, faster recovery, and
quicker return to daily activities compared to traditional multi-port laparoscopic
approaches.
Yet a direct comparison of the efficacy of these two methods in real-world, particularly
for enlarged uterus, remains inconclusive. Thus this study aims to evaluate and compare
the outcomes of these two techniques in patients with enlarged uteri. Participants will
be randomly assigned to receive one of the two surgical approaches, ensuring an unbiased
comparison of the efficacy of the procedures in terms of healing status and recovery
time.
Detailed description:
Enlarged uterus, mainly caused by adenomyosis, is often associated with symptoms like
compression of intestines and urethra(presenting as constipation, urinary frequency, and
urgency), dysmenorrhea, menstrual irregularity, and anemia due to menorrhagia. A
hysterectomy (removal of the uterus) is often recommended, especially in cases where
conservative management like medical treatment fails.
Among all the methods of hysterectomy, TU-LESS and vNOTES are noted for minimized
invasiveness and fast recovery. As vNOTES is performed through the vagina and TU-LESS
involves a single incision through the umbilicus, they both utilize natural anatomical
openings, resulting in minimal to no visible scarring.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eligible women aged 18-70 years.
- Women with indications for enlarged uterine volumes who are planning to under go
total hysterectomy.
- Patients are willing to be randomly assigned to undergo any of both approaches.
- Patients who are willing to sign the informed consent form.
Exclusion Criteria:
- Individuals who are virgins or have vaginal stenosis.
- Patients requiring concurrent surgical intervention for conditions such as ovarian
cysts or lesions of the vulva, vagina, appendix, etc.
- Presence of malignancy or strong suspicion of malignancy that may alter the planned
surgical approach.
- History of two or more pelvic surgeries or suspected severe pelvic adhesions
(rectovaginal examination suggesting rectovaginal endometriosis or limited uterine
mobility).
- History of peritoneal dialysis, pelvic radiation therapy and pelvic tuberculosis
treated with laparoscopic surgery.
- Uterine size exceeding that of a 3-month pregnancy (ultrasound indicates that the
maximum uterine diameter line is greater than 12cm).
- Patients with prolapse or pelvic inflammation.
- Diabetes mellitus with poor blood glucose control.
- Body mass index greater than 30 kg/m².
Gender:
Female
Gender based:
Yes
Gender description:
Enlarged uterine volumes occur only to female population
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Second University Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Contact:
Last name:
Hongyu Jin, MD
Phone:
02885244323
Email:
jinhongyu324@icloud.com
Start date:
December 2024
Completion date:
October 2028
Lead sponsor:
Agency:
West China Second University Hospital
Agency class:
Other
Source:
West China Second University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06663553
