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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Enlarged Uterus
- Sponsor
- West China Second University Hospital
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- postoperative liquid diet
- Status
- Not yet recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Hongyu Jin
lecturer and gynecological surgeon
West China Second University Hospital
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. Uterine size should exceed that of a 3-month pregnancy (uterine weight ≥ 280 g).
- •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 uterus exceeding approximately 20 gestational weeks in size (about 900-1000g), which is beyond the limitations of a single-site laparoscopic approach due to concerns regarding technical feasibility and safety
- •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.
- •Patients with prolapse or pelvic inflammation.
- •Diabetes mellitus with poor blood glucose control.
- •Body mass index greater than 30 kg/m².
Outcomes
Primary Outcomes
postoperative liquid diet
Time Frame: within 24 hours postoperatively
the proportion of patients able to consume a liquid diet post-surgery
passing flatus
Time Frame: within 24 hours postoperatively
the proportion of patients able to pass flatus
self-urination after catheter removal
Time Frame: within 24 hours postoperatively
The proportion of patients regaining the ability to urinate without assistance after catheter removal
ambulation
Time Frame: within 24 hours postoperatively
The proportion of patients regaining mobility after catheter removal
hospital stay
Time Frame: within 2 days postoperatively
The percentage of patients discharged within 2 days after surgery
examination of pelvic fuction
Time Frame: within 2 days postoperatively
The assessment of pelvic floor function involves evaluating Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP) and Sexual Dysfunction. The PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) is a validated tool specifically designed to evaluate sexual function in the context of pelvic floor. It is a tool that measures sexual function specifically for women affected by pelvic floor disorders, such as urinary incontinence and pelvic organ prolapse.
Secondary Outcomes
- Postoperative pain(at 12 hours and 24 hours postoperatively)
- The duration of operation(during operation)
- amount of bleeding(during operation)
- Intraoperative complications and postoperative complications(within 3 months)
- abdominal scars assessment(both at 3 and 6 months after surgery)
- the total dosage of analgesics taken(during the first 24 hours following surgery)
- The Female Sexual Function Index(FSFI)(both at baseline and 6 months after surgery)