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

NCT02297269 | Unknown

• 1 other identifier: CYYYMZ-004
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis; Surgery; gastrointestinal malignancy

Outcome Measures

Primary Outcomes (1)

• the incidence of DVT

  DVT will be measured by color Doppler ultrasonography

  within 7 days postoperatively

Secondary Outcomes (4)

• concentration of plasma D - dimer 2

  1,3,5,7 days postoperatively

• time to basic recovery

  within 7 days postoperatively

• incidence of lung infection

  within 7 days postoperatively

• incidence of incision infection

  within 7 days postoperatively

Study Arms (2)

group laparoscopic surgery

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

Device: laparoscopic surgery

group open surgery

Participants undergo open gastrointestinal malignancy surgery will be included in this group.

Device: open surgery

Interventions

laparoscopic surgery DEVICE

the method of surgery is conducted by laparoscope with proper pressure of pneumoperitoneum instead of opening the abdomen.

group laparoscopic surgery

open surgery DEVICE

the method of surgery is conducted by surgical instruments to open the abdomen.

group open surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (21)

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MeSH Terms

Conditions

Venous Thrombosis

Interventions

Laparoscopy; Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Su Min, MD

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guihua Huang, MD

CONTACT

+86-023-89011061; 435141387@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 21, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: January 1, 2016
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

CN (1)