跳至主要内容
临床试验/NCT02288988
NCT02288988已完成不适用

Results of the Minimally Invasive Collis-Nissen Technique for the Treatment of True Short Esophagus

University of Bologna2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 1995年1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
65
试验地点
2
主要终点
Number of patients with satisfactory results (Change from Baseline in the evaluation of symptoms and esophagitis at 12 months after surgery.

研究概览

简要总结

True short esophagus (TSE) is present when the distance between the esophago-gastric (E-G) junction and the apex of the hiatus is shorter than 2.5 cm, without the application of any downward pressure on the stomach, after maximal mobilization of the distal thoracic esophagus. It has been demonstrated that TSE is present in 20% of patients undergoing routine surgery for gastro-esophageal reflux disease (GERD), and in more than 50% of cases of type III-IV hiatal hernia (HH) that are treated surgically. Recent reports have confirmed the importance of diagnosing and electively treating TSE to reduce the risk of anatomic recurrence after surgery. The surgical techniques currently used for the elective treatment of TSE are based on the association of the Collis gastroplasty with an anti-reflux funduplication and the hiatoplasty, performed using minimally invasive techniques; the mortality, morbidity, and outcomes of these procedures remain subjects of debate. In light of the doubtful validity of the surgical results for TSE, some researchers have proposed that this condition should not be treated with surgical therapy. In the absence of randomized, multicenter studies designed to compare the surgical techniques used to treat TSE, the investigators believe that data obtained from a single-center study may be useful to the surgical community, provided that such data are based on an objective intra-operative diagnosis of TSE and a rigorous follow-up period.

详细描述

The pre-operative evaluation included a clinical interview, a barium swallow study, an upper gastro-intestinal (GI) endoscopy, and standard manometry. The type and severity of symptoms and the grade of reflux esophagitis were determined using a questionnaire with semi-quantitative scales.

The barium swallow study was performed to define the position of the E-G junction with respect to the diaphragm with the patient in the upright position, as well as the morphology and the type of HH. The migration of the E-G junction was radiologically diagnosed in three steps using the following differential diagnoses: hiatal insufficiency, concentric HH, and acquired short esophagus. Reflux esophagitis was classified according to the Los Angeles classification. In the absence of grade A esophagitis or a more severe type of esophagitis, patients underwent 24-h pH recording or intraluminal impedance/pH monitoring. The need for surgical therapy was determined according to defined parameters and to the current guidelines for GERD therapy.

The patient is placed in the lithotomic position; the pelvis and left chest are lifted 45° to the right to facilitate access for a left thoracostomy along the posterior axillary line.

Surgery begins via five laparoscopic ports: the camera port is placed 5 to 10 cm above the umbilicus, depending on the patient's body size, to enable access to the upper portion of the mediastinum. After the opening of the phreno-esophageal membrane, the E-G junction is isolated and the sac and fat pad (with the exception of the fat near the lesser curvature to preserve the integrity of the vagus nerves) are resected. A fiber endoscope is inserted trans-orally to determine the position of the upper margins of the gastric folds, which correspond to the E-G junction. The tip of the endoscope is placed at this level, which the surgeon marks with two clips. The intra-thoracic esophagus is mobilized by 9-12 centimeters to the level at which the left vagus nerve travels along the anterior aspect of the esophagus.

The distance between the E-G junction and the apex of the hiatus is measured after completely releasing the stomach, using an L-shaped instrument, which prevents errors associated with the two-dimensional video image. The upper arm of the L (90° based on the axis of the measurer) is placed at the apex of the diaphragm, and the distance between the base of the arm and the clip is measured in centimeters; the measurement is positive if the junction is above and negative if the junction is below the diaphragm. The length of the intra-abdominal portion of the esophagus that is suitable for the performance of a tension-free fundoplication is approximately 2.5 cm. If the E-G junction, with the stomach completely released, is still fixed above or astride the hiatus, the Collis technique is adopted. If the E-G junction is positioned below the hiatus by only 1-1.5 cm, a scenario in which even the application of slight downward traction on the stomach makes it possible to obtain the 2-3 cm of esophagus necessary to perform the fundoplication, its position creates a condition in which the decision of whether to perform a Collis gastroplasty becomes subjective. In such cases, the investigators generally perform the lengthening procedure if reflux symptoms have been present for many years, if the patient is obese, or if the patient is younger than 60 years. To perform the esophagus lengthening procedure, it is necessary to divide at least two short vessels. By turning the operating table toward the right side of the patient, the surgeon may simultaneously operate through the aforementioned 5 standard laparoscopic ports, as well as a left thoracoscopic port through which the instrument used to lengthen the esophagus is inserted. A thoracostomy is performed at the posterior axillary line at the V-VI-VII intercostal spaces, depending on the patient's body shape and size. A 12-mm valvular trocar may be used to prevent loss of pneumoperitoneum and to control intra-thoracic pressures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged > 18 years with severe GERD symptoms and esophagitis associated with short esophagus

排除标准

  • Patients aged < 18 years Patients aged > 18 years with sliding hiatal hernia

结局指标

主要结局

Number of patients with satisfactory results (Change from Baseline in the evaluation of symptoms and esophagitis at 12 months after surgery.

时间窗: 12 months

participants will be followed during the follow-up 12 months after surgery. 12 months after surgery the partecipants will perform clinical interview, upper gastrointestinal endoscopy and barium swallow

次要结局

  • Number of patients with satisfactory results(up to 60 months after surgery)

研究者

发起方
University of Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandro Mattioli

Associate Professor

University of Bologna

研究点 (2)

Loading locations...

相似试验