Clinical trial NCT06663553: Comparing the Efficacy of TU-LESS and VNOTES for Hysterectomy of Enlarged Uterus
Official title: Protocol for a Comparative Study of the Efficacy of Transumbilical Laparoendoscopic Single-site Surgery (TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) in Hysterectomy Performed on Patients with Enlarged Uterus: a Prospective Single-blinded, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Enlarged Uterus
Adenomyosis
Uterine Fibroids (UF)
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: postoperative liquid diet
timeFrame: within 24 hours postoperatively
measure: passing flatus
timeFrame: within 24 hours postoperatively
measure: self-urination after catheter removal
timeFrame: within 24 hours postoperatively
measure: ambulation
timeFrame: within 24 hours postoperatively
measure: hospital stay
timeFrame: within 2 days postoperatively
measure: examination of pelvic fuction
timeFrame: within 2 days postoperatively
Secondary outcomes:
measure: Postoperative pain
timeFrame: at 12 hours and 24 hours postoperatively
measure: The duration of operation
timeFrame: during operation
measure: amount of bleeding
timeFrame: during operation
measure: Intraoperative complications and postoperative complications
timeFrame: within 3 months
measure: abdominal scars assessment
timeFrame: both at 3 and 6 months after surgery
measure: the total dosage of analgesics taken
timeFrame: during the first 24 hours following surgery
measure: The Female Sexual Function Index(FSFI)
timeFrame: both at baseline and 6 months after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital
state: Sichuan
Study officials:
References:
citation: Benassi L, Rossi T, Kaihura CT, Ricci L, Bedocchi L, Galanti B, Vadora E. Abdominal or vaginal hysterectomy for enlarged uteri: a randomized clinical trial. Am J Obstet Gynecol. 2002 Dec;187(6):1561-5. doi: 10.1067/mob.2002.127596.
citation: Zhang W, Deng L, Yang F, Liu J, Chen S, You X, Gou J, Zi D, Li Y, Qi X, Wang Y, Zheng Y. Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e074478. doi: 10.1136/bmjopen-2023-074478.