The Impact of Laparoscopic Versus Open Surgeries on the Incidence of Postoperative Deep Vein Thrombosis in Patients With Gastrointestinal Malignancy ---A Cohort Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Impact of Laparoscopic Versus Open Surgeries on the Incidence of Postoperative Deep Vein Thrombosis in Patients With Gastrointestinal Malignancy ---A Cohort Study

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Device: laparoscopic surgery
* Device: open surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosed with gastrointestinal malignancy aged from 18 to 75 years old woman or man classification of American Society of Anesthesiologists is I to III Exclusion Criteria: patients with rectal tumor need to resect anus tumor distant metastasis patients with palliative surgery diagnosed with DVT pre-operation body mass index ≤18 or ≥30 coagulation dysfunction cerebral hemorrhage history pre-operation hepatorenal dysfunction being pregnant mental disorder patients with peritonitis or uncontrolled general infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group laparoscopic surgery<br>Participants undergo laparoscopic gastrointestinal malignancy surgery will be included in this group. The pressure of pneumoperitoneum maintain in 10-12mmHg. | Device: laparoscopic surgery<br>* the method of surgery is conducted by laparoscope with proper pressure of pneumoperitoneum instead of opening the abdomen.<br>|
| group open surgery<br>Participants undergo open gastrointestinal malignancy surgery will be included in this group. | Device: open surgery<br>* the method of surgery is conducted by surgical instruments to open the abdomen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of DVT | DVT will be measured by color Doppler ultrasonography | within 7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of plasma D - dimer 2 | concentration of plasma D - dimer 2 is measured by professional machine from the patients' blood | 1,3,5,7 days postoperatively | 
| time to basic recovery | time to first flatus and mobility | within 7 days postoperatively | 
| incidence of lung infection | lung infection is diagnosed by X-ray ,lab examination and clinical symptoms | within 7 days postoperatively | 
| incidence of incision infection | incision infection is diagnosed by lab examination and clinical symptoms | within 7 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep vein thrombosis, Surgery, gastrointestinal malignancy