NCT01844960已完成不适用
A Prospective Double Blinded Randomised Control Trial Comparing Laparoscopic Single Incision Versus Multiple Incision Adjustable Gastric Band Surgery in Patients With Morbid Obesity
King's College Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
A double blinded randomised control trial comparing the differences between laparoscopic single incision versus multiple port bariatric surgery in morbidly obese patients (BMI>35). Single incision surgery is a new minimally invasive surgical technique requiring the surgeon to operate through one small single incision and is virtually scarless. The traditional laparoscopic approach to abdominal surgery is through multiple small incisions (4-7 ports) across the whole abdomen. This study seeks to identify the risks, benefits and costs of the adjustable gastric band insertion via single incision and multiple incision within the morbidly obese patient group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbidly obese patients, BMI ≥35 kg/m2
- •Undergoing gastric band surgery
- •Undergone a pre-weight loss surgery risk assessment
- •Fit for anaesthesia and surgery
- •Fulfil day surgery criteria
- •Full understanding of bariatric procedure, with informed consent of the risks and benefits of laparoscopic single incision and multiple incision surgery
排除标准
- •Pregnancy
- •History of portal hypertension
- •Previous gastric surgery or large hiatus hernia
- •Previous laparotomy or bariatric surgery
- •Weight >150kg (day surgery limit)
- •Unwilling to consider surgical treatment
结局指标
主要结局
Pain
时间窗: first 10 days post-operatively
次要结局
- Time to Discharge(Post-operative ward stay (estimated 2-8 hours))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon RupturesDistal Bicep Tendon RuptureNCT01322828Hand and Upper Limb Clinic, Canada92
Unknown
不适用
Submucosa/Mucosal Pharyngeal Flap TrialVelopharyngeal InsufficiencyNCT03187600Lawson Health Research Institute20
尚未招募
4 期
Study to compare either simple placement of mesh, placement of mesh after suture closure of the hernia defect or placement of mesh after covering the defect with peritoneal tissue during laparoscopic surgery for the treatment of abdominal wall hernia.CTRI/2023/08/056745Dr Baba Saheb Ambedkar Hospital
尚未招募
不适用
A clinical trial to compare manually made kshar sutra with kshar sutra prepared by automated machine in patients having Fistula in Ano.CTRI/2021/12/038414CCRAS
尚未招募
不适用
The effect of Parietene self-fixing semi-resorbable mesh on inguinal pain developmentInguinal hernia, mesh, chronic painHernia inguinalis, mesh, chronische pijnNL-OMON25668MJA Loos MDDepartment of SurgeryMaxima Medical CentreDe Run 4600, 5500 MB Veldhoven, the Netherlands350