NCT05691348招募中不适用
Same Day Ambulatory Appendectomy (SAMBA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 33
- 主要终点
- To demonstrate that outpatient care, compared with conventional care, in selected patients with acute uncomplicated appendicitis operated by laparoscopy, is non-inferior in terms of overall morbi-mortality on the 30th postoperative day.
研究概览
简要总结
The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:
- Optimization of the care pathway, reducing the length of stay in hospital (a major issue in the context of the COVID-19 (coronavirus disease) pandemic) liberating patient beds and staff, and reducing the risk of nosocomial exposure.
- Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds.
- Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization.
- Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.
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
- None
入排标准
- 年龄范围
- 15 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 15-74 years
- •BMI ≤ 35 kg/m2
- •Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI)
- •Temperature ≤ 38,1°C and > 35,5°C
- •Appendix diameter > 6mm and ≤ 15mm
- •Without effusion or with only localized peri-appendicular effusion
- •Infiltration of peri-appendicular fat without abscess or plastron
- •No sign of perforation
- •Leukocytes ≤ 18,000G/L AND
- •CRP (C reactive protein) ≤ 60mg/L
- •If pain, calmed by level 3 analgesic at maximum
- •Ambulatory criteria
- •Availability of monitoring by a relative during the 12 hours after discharge from the hospital
- •Residence located less than 20 minutes by car from a health center (hospital or clinic)
- •Access to a telephone mobile or fixed in case of problems
- •Signature of the written informed consent form by the patient
- •If the patient is a minor, signature of the written informed consent form by both parents or their legal representative
- •Affiliation to a French health insurance scheme or equivalent
排除标准
- •Criteria that exclude ambulatory care such as an ASA score (Physical status score) > 2, severe or uncontrolled comorbidities, severe pulmonary disease including obstructive sleep apnea, anticoagulation or antiplatelet drug or contraindication to ambulatory surgery such as intubation difficulties
- •Presence of active cancer, a malignant hemopathy, drug addiction, coagulopathy, immunosuppressive treatment
- •Non-acute or interval appendectomy, i.e. after antibiotic treatment of a complicated appendicitis of the plastron or drainage of an appendicular abscess;
- •History of pelvic surgery
- •Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancy test: plasmatic β-hCG (human chorionic gonadotropin) or urinary test), adult under guardianship or deprived of freedom. Pregnant women are considered to have a full stomach, with risk of inhalation at anesthetic induction and represent a contraindication to ambulatory surgery. In addition, the need to perform abdominal surgery on a pregnant woman requires obstetric monitoring that is difficult to reconcile with management in an outpatient surgery unit (need for obstetric ultrasound or monitoring).
- •Suspicion of a tumor of the appendix : Mucocele and pseudomyxoma, Carcinoid tumor, Adenocarcinoma of the appendix, Another type of tumor
结局指标
主要结局
To demonstrate that outpatient care, compared with conventional care, in selected patients with acute uncomplicated appendicitis operated by laparoscopy, is non-inferior in terms of overall morbi-mortality on the 30th postoperative day.
时间窗: 30 days post surgery
Morbi-mortality will be assessed by classifying post-operative complications according to Clavien-Dindo classification. It will be compared between both groups ("ambulatory pathway" versus "conventional hospitalization" CONV) on the 30th postoperative day. The Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death). Complications that potentially lead to long-lasting disability after discharge (e.g.: paralysis of a vocal cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a long-term follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.
次要结局
- To study the economic impact (utility) of outpatient appendectomy management compared to conventional hospitalization(up to the 30th day post surgery)
- To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage)(up to the 30th day post surgery)
- To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery(up to the 30th day post surgery)
- To compare between both groups, the rate of laparoscopic re-intervention(up to the 30th day post surgery)
- To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy(up to the 30th day post surgery)
- To evaluate the rate of conversion from outpatient to conventional care(up to the 30th day post surgery)
- To estimate the cost of outpatient appendectomy management(up to the 30th day post surgery)
- To compare between both groups, at post-operative day 30, the rehospitalization rate(30 days post surgery)
- To compare between both groups, patient satisfaction 7 and 30 days post surgery(7 and 30 days post surgery)
- To study the generalization of outpatient appendectomy management in all French hospitals at the budgetary level(up to the 30th day post surgery)
- To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy(30 days post surgery)
- To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization(30 days post surgery)
- To compare between both groups, the severe morbidity (Clavien-Dindo III, IV, V) during 30 days post surgery(up to the 30th day post surgery)
- To compare between both groups, patient quality of life 7 and 30 days post surgery(at inclusion and at 7 and 30 days post surgery)
- To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization(up to the 30th day post surgery)
- To study the generalization of outpatient appendectomy management in all French hospitals at a strategic level(up to the 30th day post surgery)
研究者
研究点 (33)
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