CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02077673
NCT02077673N/ACompleted

Robotic Assisted Laparoscopy Versus Open Gastroesophageal Resection; Effects on the Mesenteric Traction Reflex and PGI2 Levels

Rigshospitalet, Denmark·observational·Posted Mar 4, 2014·Updated May 5, 2015

In Brief

An observational study for Gastroesophageal Junction Adenocarcinoma and Surgery. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a massive surgical intervention. Currently, gastroesophageal cancer surgery is performed with upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology, Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted laparoscopy, is in the progress of being implemented in this field as they are hypothesized to be more beneficial for the patients, and in some aspects better than conventional laparoscopic surgery. The operative procedure is often complicated by low blood pressure (systolic blood pressure less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably accompanied by a reduced splanchnic microcirculatory flow, leading to increased morbidity. Hypotension may be due to several factors, among them are epidural analgesia, mesentery traction reflex, and inflammatory and vasoactive hormones. Aim of the project The aim of the project is, through a series of sub-projects, to validate or invalidate the relationship between changes in the microcirculatory blood flow in the stomach and the systemic hemodynamic changes. Furthermore, the aim is to assess the changes in the microcirculatory blood flow as a consequence of the thoracic epidural anesthesia. In addition, the aim is to assess the hypothesis that the mesenteric traction reflex and changes in the PGI2 levels may influence systemic hemodynamic changes, and that robotic assisted MIT will attenuate the mesenteric traction reflex and changes in PGI2 compared to open surgery.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 4, 2014
Enrollment StartDec 1, 2013
Primary CompletionJan 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.3 years ago