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

• Conditions: Deep Vein Thrombosis
• Interventions: Device: laparoscopic surgery; Device: open surgery

• Registration Number: NCT02297269
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-21
• Last Update Posted: 2014-11-21
• Study Start: 2014-12
• Primary Completion: 2015-06
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group laparoscopic surgery	laparoscopic surgery	Participants undergo laparoscopic gastrointestinal malignancy surgery will be included in this group. The pressure of pneumoperitoneum maintain in 10-12mmHg.
group open surgery	open surgery	Participants undergo open gastrointestinal malignancy surgery will be included in this group.

Primary Outcome Measures

Name	Time	Method
the incidence of DVT	within 7 days postoperatively	DVT will be measured by color Doppler ultrasonography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China