Clinical trial NCT02297269: The Impact of Laparoscopic Versus Open Surgeries on the Incidence of Postoperative Deep Vein Thrombosis in Patients With Gastrointestinal Malignancy ---A Cohort Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deep Vein Thrombosis
Keywords: Deep vein thrombosis
Surgery
gastrointestinal malignancy
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants will be selected from the department of gastrointestinal surgery in the first affiliated hospital of chongqing medical university

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosed with gastrointestinal malignancy
2. aged from 18 to 75 years old
3. woman or man
4. classification of American Society of Anesthesiologists is I to III

Exclusion Criteria:

1. patients with rectal tumor need to resect anus
2. tumor distant metastasis
3. patients with palliative surgery
4. diagnosed with DVT pre-operation
5. body mass index ≤18 or ≥30
6. coagulation dysfunction
7. cerebral hemorrhage history pre-operation
8. hepatorenal dysfunction
9. being pregnant
10. mental disorder
11. patients with peritonitis or uncontrolled general infection

Primary outcomes:
measure: the incidence of DVT
timeFrame: within 7 days postoperatively
Secondary outcomes:
measure: concentration of plasma D - dimer 2
timeFrame: 1,3,5,7 days postoperatively
measure: time to basic recovery
timeFrame: within 7 days postoperatively
measure: incidence of lung infection
timeFrame: within 7 days postoperatively
measure: incidence of incision infection
timeFrame: within 7 days postoperatively
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Su Min, MD
role: PRINCIPAL_INVESTIGATOR
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