Adenomyosis, Enlarged Uterus, Uterine Fibroids (UF)
Conditions
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.
Interventions
Sponsors
West China Second University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative liquid diet | within 24 hours postoperatively | the proportion of patients able to consume a liquid diet post-surgery |
| passing flatus | within 24 hours postoperatively | the proportion of patients able to pass flatus |
| self-urination after catheter removal | within 24 hours postoperatively | The proportion of patients regaining the ability to urinate without assistance after catheter removal |
| ambulation | within 24 hours postoperatively | The proportion of patients regaining mobility after catheter removal |
| hospital stay | within 2 days postoperatively | The percentage of patients discharged within 2 days after surgery |
| examination of pelvic fuction | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | at 12 hours and 24 hours postoperatively | It is measured by the VAS score. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). |
| The Female Sexual Function Index(FSFI) | both at baseline and 6 months after surgery | Using either a paper sheet or online questionnaire |
| The duration of operation | during operation | It will be measured in min utes, starting from the initiation of the skin (or vag inal) incision and concluding upon the completion of the skin (or vaginal) suturing. If a frozen biopsy is needed during the operation, the increased time for the frozen biopsy should be subtracted. However, pa tients for whom the surgical method is changed due to the result of the frozen biopsy should be excluded. |
| amount of bleeding | during operation | — |
| Intraoperative complications and postoperative complications | within 3 months | We use the Clavien-Dindo classification to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. |
| abdominal scars assessment | both at 3 and 6 months after surgery | The Patient and Observer Scar Assessment Scale (POSAS) will be used. It consists of two separate scales: the Patient Scale and the Observer Scale and measures scar quality (i.e. how the scar looks and feels) from both perspectives. The observer scores six items: vascularization, pigmentation, thickness, surface roughness, pliability, and surface area. The patient scores six items: pain, pruritus, color, thickness, relief, and pliability. All included items are scored on the same polytomous 10-point scale, in which a score of 1 is given when the scar characteristic is akin to 'normal skin' and a score of 10 reflects the 'worst imaginable scar'. All items are summed to give a total scar score, and therefore, a higher score represents a poorer scar quality. |
| the total dosage of analgesics taken | during the first 24 hours following surgery | also categorized by analgesic type |
Countries
China
Outcome results
None listed