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

Deep Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02297269
• Other study ID #: CYYYMZ-004
• Status: Not yet recruiting
• Phase: N/A
• First received: November 17, 2014
• Last updated: November 19, 2014
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: November 2014
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Guihua Huang, MD
• Phone: +86-023-89011061
• Email: 435141387[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical 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 gastrointestinal malignancy

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• laparoscopic surgery
the method of surgery is conducted by laparoscope with proper pressure of pneumoperitoneum instead of opening the abdomen.
• open surgery
the method of surgery is conducted by surgical instruments to open the abdomen.

Locations

Country	Name	City	State
China	The First Affliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (21)

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Filtenborg Tvedskov T, Rasmussen MS, Wille-Jørgensen P. Survey of the use of thromboprophylaxis in laparoscopic surgery in Denmark. Br J Surg. 2001 Oct;88(10):1413-6. — View Citation

Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW; American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656. — View Citation

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Huang A, Barber N, Northeast A. Deep vein thrombosis prophylaxis protocol--needs active enforcement. Ann R Coll Surg Engl. 2000 Jan;82(1):69-70. — View Citation

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. — View Citation

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. — View Citation

Michota F. Venous thromboembolism: epidemiology, characteristics, and consequences. Clin Cornerstone. 2005;7(4):8-15. Review. — View Citation

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. — View Citation

Nguyen NT, Wolfe BM. The physiologic effects of pneumoperitoneum in the morbidly obese. Ann Surg. 2005 Feb;241(2):219-26. Review. — View Citation

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. — View Citation

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. — View Citation

Prevention of venous thrombosis and pulmonary embolism. NIH Consensus Development. JAMA. 1986 Aug 8;256(6):744-9. — View Citation

Schaepkens Van Riempst JT, Van Hee RH, Weyler JJ. Deep venous thrombosis after laparoscopic cholecystectomy and prevention with nadroparin. Surg Endosc. 2002 Jan;16(1):184-7. Epub 2001 Oct 5. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of DVT	DVT will be measured by color Doppler ultrasonography	within 7 days postoperatively	No
Secondary	concentration of plasma D - dimer 2	concentration of plasma D - dimer 2 is measured by professional machine from the patients' blood	1,3,5,7 days postoperatively	No
Secondary	time to basic recovery	time to first flatus and mobility	within 7 days postoperatively	No
Secondary	incidence of lung infection	lung infection is diagnosed by X-ray ,lab examination and clinical symptoms	within 7 days postoperatively	No
Secondary	incidence of incision infection	incision infection is diagnosed by lab examination and clinical symptoms	within 7 days postoperatively	No