Conventional Laparoscopy Versus Robotic Surgery for Pain Relief in Patients With Deep Infiltrating Endometriosis: a Pilot Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain medication
研究概览
简要总结
Background: Endometriosis is a common disease, affecting women in their reproductive age suffering from infertility, adnexal masses and chronic pelvic pain, obstruction of the bowel or urinary tract. Deeply infiltrating endometriosis (DIE) is defined as a solid endometriosis mass situated more than 5 mm deep to the peritoneum. These lesions are considered very active and are strongly associated with pelvic pain symptoms.
Surgery is recommended in women with pain resistant to medical therapy and in women with contraindications to or refusal of medical therapy. Further indications for surgical treatment are the need of excluding malignancy in an adnexal mass, obstruction of the bowel or urinary tract. It is hypothesized that in patients with lesions in complex anatomic sites, a robot-assisted approach may provide improved instrument articulation compared with conventional laparoscopy, but no data are available.
Aims: The aim of this study is to perform a pilot study investigating differences between robot-assisted laparoscopy compared to conventional laparoscopy regarding subjective symptom outcome, evaluated by VAS score for non-menstrual pelvic pain and dysmenorrhea.
Study population: The study population will consist of women aged between 18 and 51 years who are referred to our gynecologic outpatient clinic due to symptomatic endometriosis. Women with suggested DIE and an indication for surgery can be included in this trial.
Methods: Laparoscopic-assisted resection of endometriosis will be performed using up to five 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. Superficial and deep endometriosis resection will be performed in the usual standard fashion. Histological confirmation of endometriosis will be performed. The primary outcome is subjective symptom improvement. This will be evaluated by visual analog scale (VAS) for dysmenorrhea and non-menstrual pelvic pain on a daily basis for at least 1 calendar month before the operation to obtain adequate baseline measurements. This evaluation will be repeated 3 and 6 months after surgery.
详细描述
Experimental Plan Study design
This trial is a single-center, prospective, pilot study conducted with the aim of determining differences of robotic surgery compared to simple laparoscopic surgery with regard to the primary outcome in patients with suspected endometriosis. Postoperative follow-up will take place after 3 and 6 months. All women referred to our department for deep endometriosis will undergo clinical examination by a senior surgeon experienced in endometriosis as well as MRI examination. We will include all patients with suspected DIE affecting Enzian compartments A, B and C with lesions sized ≥1 (A2-3, B2-3 and C2-3). In cases with colorectal involvement, irrigoscopy will be used to check for digestive tract stenosis and associated digestive tract localizations. Complementary examinations, such as cystoscopy will be performed in women with associated involvement of urinary tract.
In women with pregnancy intention and deep endometriosis, an exhaustive assessment of the disease will systematically be performed before deciding between primary surgery and primary assisted reproductive techniques.
Gynecological examination is performed at each visit. Furthermore, subjective outcome will be assessed with standardized questionnaires.
Study setting Participants and recruitment The study population will consist of women aged between 18 and 51 years who are referred to our gynecologic outpatient clinic due to symptomatic endometriosis. Women with suggested DIE affecting Enzian compartments A, B and C with lesions sized ≥1 (A2-3, B2-3 and C2-3) and an indication for surgery can be included in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Suspected deep infiltrating endometriosis affecting Enzian compartments A, B and C with lesions sized ≥1 (A2-3, B2-3 and C2-3)
- •Mean VAS score for dysmenorrhea or non-menstrual pelvic pain >= 5 (assessed at 5 days/ month with the heaviest symptoms)
- •Surgical endometriosis resection is planned
排除标准
- •History of malignant diseases
- •Current systemic glucocorticoid or immunosuppressant treatment
- •Subject is unable or unwilling to participate
- •Postmenopausal women
- •Combined oral contraception
结局指标
主要结局
Pain medication
时间窗: 6 months after the operation
Medication being taken for endometriosis-associated pain will be assessed in this daily questionnaire (type of medication and dosage).
Patients' Global Impression of Change (PGIC)
时间窗: 6 months after the operation
PGIC will be used to calculate the rate of responders 3 and 6 months after the operation
Menstrual bleeding
时间窗: 6 months after the operation
Menstrual bleeding will be assessed in this daily questionnaire (yes versus no).
Change in Visual analog scale (VAS) from baseline to 3 and 6 months after the operation
时间窗: 6 months after the operation
Patients will be asked to complete a VAS for dysmenorrhea and non-menstrual pelvic pain on a daily basis for at least 1 calendar month at baseline and after 3 months and after 6 months following the operation. For VAS score we will calculate the mean of the 5 days/months with the highest VAS score. Patients will be asked to write down their VAS score before taking pain medication.
次要结局
- rate of intraoperative adverse events(1 day)
- operation time(1 day)
- length of hospitalization (following the operation)(2 weeks)
- change of the Endometriosis Health Profile (EHP) EHP-30 from baseline to 3 and 6 months after the operation(6 months after the operation)
- 10-point Likert scale for cosmetic satisfaction(6 months after the operation)
- rate of postoperative adverse events(4 weeks)
- blood loss(1 day)
- Change in Biberoglu and Behrman (B&B) score from baseline to 3 and 6 months after the operation(6 months after the operation)
- laparotomic conversion rate(1 day)
- Disease recurrence rate up to 12 months after surgery(12 months after the operation)
研究者
Christine Bekos
Dr.
Medical University of Vienna