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

November 19, 2014 updated by: Min Su, First Affiliated Hospital of Chongqing Medical University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
the method of surgery is conducted by laparoscope with proper pressure of pneumoperitoneum instead of opening the abdomen.
group open surgery
Participants undergo open gastrointestinal malignancy surgery will be included in this group.
Device: open surgery
the method of surgery is conducted by surgical instruments to open the abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of DVT
Time Frame: within 7 days postoperatively
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
Time Frame: 1,3,5,7 days postoperatively
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 Frame: within 7 days postoperatively
time to first flatus and mobility
within 7 days postoperatively
incidence of lung infection
Time Frame: within 7 days postoperatively
lung infection is diagnosed by X-ray ,lab examination and clinical symptoms
within 7 days postoperatively
incidence of incision infection
Time Frame: within 7 days postoperatively
incision infection is diagnosed by lab examination and clinical symptoms
within 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYYYMZ-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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