Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- Percentage of same day discharge
研究概览
简要总结
Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy.
Objective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.
Study design: The study concerns a single-blinded, multicentre, randomised controlled trial.
Study population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication.
Intervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups.
Main study parameters/endpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8.
The secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
vNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.
详细描述
The hysterectomy is one of the most performed gynaecological surgeries worldwide.
In the Netherlands about 14.500 hysterectomies are performed yearly. The most common benign indications to perform a hysterectomy are abnormal uterine bleeding, uterine leiomyomas, endometriosis or adenomyosis, chronic pelvic pain, uterine prolapse, benign ovarian neoplasm, hyperplasia or atypia of the endometrium or cervical dysplasia.
The four approaches to perform a hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), (total) laparoscopic hysterectomy ((T)LH) and robotic-assisted hysterectomy (RH).
VH appears to be superior to the AH, resulting in a quicker recovery. The LH results in a quicker recovery than the AH and VH, but increases the risks of damage to the bladder or ureter. That is why a recent Cochrane review advises to perform a VH when feasible for women undergoing a hysterectomy for a benign indication. When VH is technically not feasible, a LH or AH is performed. LH resulted in more rapid recovery, fewer febrile episodes and less wound complications compared to AH. The RH is not superior compared to the LH and is associated with higher costs.
Since the introduction of laparoscopy, the VH and AH decreased and the rate of LH significantly increased between 2002 and 2012. Performing a LH gives the opportunity to inspect the abdominal cavity and to easily perform an opportunistic salpingectomy compared to VH. An opportunistic salpingectomy during a hysterectomy for benign indication might reduce the overall risk of ovarian cancer.
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)
盲法说明
Participant is blinded for which surgery they will undergo
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written and orally given informed consent
- •18 years and older
- •Native Dutch speaker or in control of the Dutch language in speaking and writing
- •Indication for hysterectomy for benign indication
- •Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination
排除标准
- •Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist
- •History of more than 1 caesarean section
- •History of endometriosis
- •History of rectal surgery
- •History of pelvic radiation
- •Suspected rectovaginal endometriosis
- •History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis)
- •Virginity
- •Pregnancy
- •Indication for anterior or posterior colporrhaphy during the same surgery
- •Indication of mid urethral slings
- •Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.
结局指标
主要结局
Percentage of same day discharge
时间窗: First 24hours after surgery
Same day discharge
次要结局
- Treatment related outcomes - 7(Day 7 after surgery)
- Treatment related outcomes-1(During surgery)
- Treatment related outcomes -6(Day 7 after surgery)
- Treatment related outcomes - 8(Week 6 after surgery)
- Treatment related outcomes -5(First 24 hours after surgery)
- Intended number of salphingectomies in each group(During surgery)
- Costs(Week 12 after sugery)
- Treatment related outcomes-2(During surgery)
- Performed number of salphingectomies in each group(During surgery)
- Health- related Quality of LIfe (EQ-5D-5L questionnaire)(Week 12 after surgery)
- Treatment related outcomes -4(During surgery)
- Treatment related outcomes - 9(Week 6 after surgery)
- Complications(Week 6 after surgery)
- Recovery Index-10 (RI-10) pre- and postoperative(Week 12 after surgery)
- Cost effectiveness(Week 12 after surgery)
- Treatment related outcomes- 3(During surgery)
研究者
Ilse Bekkers
Doctor in training to be a gynaecologist
Zuyderland Medisch Centrum