Deep Vein Thrombosis Clinical Trial
Official title:
The Impact of Laparoscopic Versus Open Surgeries on the Incidence of Postoperative Deep Vein Thrombosis in Patients With Gastrointestinal Malignancy ---A Cohort Study
Deep vein thrombosis (DVT) is a common complication of surgery, which could result in pulmonary embolism (PE). PE is a serious and potentially life-threatening syndrome. The purpose of this study is to investigate the impact of laparoscopic versus open surgeries on the incidence of postoperative DVT in patients with gastrointestinal malignancy
Compared with open surgery (OS), the laparoscopic surgery (LS) can conduct less invasion,
less pain and decrease the rate of wound infection and probably improve the quality of life
for patients. For these benefits, laparoscopic surgery was widely used for gastrointestinal
surgery. DVT is a common complication of surgery. However, whether LS can reduce the
incidence of postoperative DVT is unclear. So the investigators conduct a cohort study, with
a sufficient sample size in a rigorous scientific overview, to investigate the impact of
laparoscopic versus open surgeries on the incidence of postoperative DVT in patients with
gastrointestinal malignancy.
This study was approved by the institutional review board of the First Affiliated Hospital
of Chongqing Medical University. The protocol design is in accordance with Consolidated
Standards of Reporting Trials (CONSORT) statements.
This study is designed as a cohort study to investigate the incidence of postoperative DVT
in patients undergoing gastrointestinal malignancy laparoscopic surgery (group LS) and open
surgery (group OS).
Participants in group LS will receive laparoscopic gastrointestinal malignancy surgery.
Participants in group OS will receive open gastrointestinal malignancy surgery. All
participants will receive unified post-operative analgesia and the prophylaxis of infection
and thromboembolism.
The primary outcome of this study is the incidence of DVT after laparoscopic and open
gastrointestinal malignancy surgery within 7 days postoperatively.
The secondary outcomes of this study including: concentration of plasma D - dimer 2, time to
first flatus and mobility, incidence of lung infection and infection of incision within 7
days postoperatively, lengths of hospital stay .
This study will be conducted under the supervision of an independent auditor. Every week,
the auditor checked the data of the participants the day after the survey was conducted.
Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in
sampled population. When there is disagreement between surgeon and anesthesiologists in
evaluating the prognosis of patients, the auditor must solve this disagreement by discussion
with both evaluators. Data were double-entered by two statisticians with limitation of
access and locked during statistical analysis.
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Observational Model: Cohort, Time Perspective: Prospective
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