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Deep Vein ThrombosisNCT02297269

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

An observational study of Deep Vein Thrombosis, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Deep Vein Thrombosis
What is being tested?
laparoscopic surgery and open surgery
Type of treatment
Medical device
How many people
230 participants
Where
1 siteChina
Study dates
Dec 2014to Jan 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: participants will be selected from the department of gastrointestinal surgery in the first affiliated hospital of chongqing medical university

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • cerebral hemorrhage history pre-operation
  • hepatorenal dysfunction
  • being pregnant
  • mental disorder
  • patients with peritonitis or uncontrolled general infection

Trial locations and contacts

1 site in 1 country.

Guihua Huang, MD contact

+86-023-89011061

435141387@qq.com

China1 site

  • The First Affliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Su Min, MD, +86-23-89011068, ms89011068@163.com

    Guihua Huang, MD, +86-23-89011061, 435141387@qq.com

Other trials in China

About this study

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

Read the 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.

Being tested
laparoscopic surgery, open surgery
Keywords
Deep vein thrombosis, Surgery, gastrointestinal malignancy
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopic surgeryDevice

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

  • open surgeryDevice

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

Study groups in NCT02297269
Study groupRoleWhat they receive
group laparoscopic surgeryParticipants undergo laparoscopic gastrointestinal malignancy surgery will be included in this group. The pressure of pneumoperitoneum maintain in 10-12mmHg.
Receives: Device: laparoscopic surgery
group open surgeryParticipants undergo open gastrointestinal malignancy surgery will be included in this group.
Receives: Device: open surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the incidence of DVT

    DVT will be measured by color Doppler ultrasonography

    Measured: within 7 days postoperatively

Secondary outcomes (4)

  1. concentration of plasma D - dimer 2

    concentration of plasma D - dimer 2 is measured by professional machine from the patients' blood

    Measured: 1,3,5,7 days postoperatively

  2. time to basic recovery

    time to first flatus and mobility

    Measured: within 7 days postoperatively

  3. incidence of lung infection

    lung infection is diagnosed by X-ray ,lab examination and clinical symptoms

    Measured: within 7 days postoperatively

  4. incidence of incision infection

    incision infection is diagnosed by lab examination and clinical symptoms

    Measured: within 7 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2015 (estimated)
  4. Study completionJan 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297269
Sponsor's protocol ID
CYYYMZ-004
Status last verified
Nov 2014
First submitted
17 Nov 2014
Last updated
21 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Michota F. Venous thromboembolism: epidemiology, characteristics, and consequences. Clin Cornerstone. 2005;7(4):8-15. doi: 10.1016/s1098-3597(05)80098-5.

    PubMed 16758647

  • Nguyen NT, Owings JT, Gosselin R, Pevec WC, Lee SJ, Goldman C, Wolfe BM. Systemic coagulation and fibrinolysis after laparoscopic and open gastric bypass. Arch Surg. 2001 Aug;136(8):909-16. doi: 10.1001/archsurg.136.8.909.

    PubMed 11485526

  • Nguyen NT, Wolfe BM. The physiologic effects of pneumoperitoneum in the morbidly obese. Ann Surg. 2005 Feb;241(2):219-26. doi: 10.1097/01.sla.0000151791.93571.70.

    PubMed 15650630

  • Patel MI, Hardman DT, Nicholls D, Fisher CM, Appleberg M. The incidence of deep venous thrombosis after laparoscopic cholecystectomy. Med J Aust. 1996 Jun 3;164(11):652-4, 656.

    PubMed 8657026

  • Lord RV, Ling JJ, Hugh TB, Coleman MJ, Doust BD, Nivison-Smith I. Incidence of deep vein thrombosis after laparoscopic vs minilaparotomy cholecystectomy. Arch Surg. 1998 Sep;133(9):967-73. doi: 10.1001/archsurg.133.9.967.

    PubMed 9749849

  • Brown JA, Garlitz C, Gomella LG, McGinnis DE, Diamond SM, Strup SE. Perioperative morbidity of laparoscopic radical prostatectomy compared with open radical retropubic prostatectomy. Urol Oncol. 2004 Mar-Apr;22(2):102-6. doi: 10.1016/S1078-1439(03)00101-7.

    PubMed 15082005

  • O'Shea RT, Cook JR, Seman EI. Total laparoscopic hysterectomy: a new option for removal of the large myomatous uterus. Aust N Z J Obstet Gynaecol. 2002 Aug;42(3):282-4. doi: 10.1111/j.0004-8666.2002.00282.x.

    PubMed 12230064

  • Geerts WH, Heit JA, Clagett GP, Pineo GF, Colwell CW, Anderson FA Jr, Wheeler HB. Prevention of venous thromboembolism. Chest. 2001 Jan;119(1 Suppl):132S-175S. doi: 10.1378/chest.119.1_suppl.132s. No abstract available.

    PubMed 11157647

  • Federman DG, Kirsner RS. An update on hypercoagulable disorders. Arch Intern Med. 2001 Apr 23;161(8):1051-6. doi: 10.1001/archinte.161.8.1051.

    PubMed 11322838

  • Silver D, Vouyouka A. The caput medusae of hypercoagulability. J Vasc Surg. 2000 Feb;31(2):396-405. doi: 10.1016/s0741-5214(00)90170-8.

    PubMed 10664508

  • Wilson YG, Allen PE, Skidmore R, Baker AR. Influence of compression stockings on lower-limb venous haemodynamics during laparoscopic cholecystectomy. Br J Surg. 1994 Jun;81(6):841-4. doi: 10.1002/bjs.1800810616.

    PubMed 8044597

  • Christen Y, Reymond MA, Vogel JJ, Klopfenstein CE, Morel P, Bounameaux H. Hemodynamic effects of intermittent pneumatic compression of the lower limbs during laparoscopic cholecystectomy. Am J Surg. 1995 Oct;170(4):395-8. doi: 10.1016/s0002-9610(99)80311-0.

    PubMed 7573736

  • Ebner H, Lindemayr H. [Leg ulcer and allergic eczematous contact dermatitis incidence of contact allergies induced by topical therapy (author's transl)]. Wien Klin Wochenschr. 1977 Mar 18;89(6):185-8. German.

    PubMed 848026

  • Ido K, Suzuki T, Kimura K, Taniguchi Y, Kawamoto C, Isoda N, Nagamine N, Ioka T, Kumagai M, Hirayama Y. Lower-extremity venous stasis during laparoscopic cholecystectomy as assessed using color Doppler ultrasound. Surg Endosc. 1995 Mar;9(3):310-3. doi: 10.1007/BF00187775.

    PubMed 7597605

  • Caprini JA, Arcelus JI, Laubach M, Size G, Hoffman KN, Coats RW 2nd, Blattner S. Postoperative hypercoagulability and deep-vein thrombosis after laparoscopic cholecystectomy. Surg Endosc. 1995 Mar;9(3):304-9. doi: 10.1007/BF00187774.

    PubMed 7597604

Questions about this trial

What is this clinical trial studying?

An observational study of Deep Vein Thrombosis, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guihua Huang, MD (+86-023-89011061, 435141387@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of DVT (time frame: within 7 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297269, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.

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