The Impact of Laparoscopic Versus Open Surgeries on the Incidence of Postoperative Deep Vein Thrombosis in Patients With Gastrointestinal Malignancy ---A Cohort Study
NCT ID: NCT02297269
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
230 participants
OBSERVATIONAL
2014-12-31
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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group laparoscopic surgery
Participants undergo laparoscopic gastrointestinal malignancy surgery will be included in this group. The pressure of pneumoperitoneum maintain in 10-12mmHg.
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.
open surgery
the method of surgery is conducted by surgical instruments to open the abdomen.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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First Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Min Su
Department of Anesthesiology and Pain Medicine
Principal Investigators
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Su Min, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Locations
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The First Affliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Michota F. Venous thromboembolism: epidemiology, characteristics, and consequences. Clin Cornerstone. 2005;7(4):8-15. doi: 10.1016/s1098-3597(05)80098-5.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Dexter SP, Griffith JP, Grant PJ, McMahon MJ. Activation of coagulation and fibrinolysis in open and laparoscopic cholecystectomy. Surg Endosc. 1996 Nov;10(11):1069-74. doi: 10.1007/s004649900242.
Filtenborg Tvedskov T, Rasmussen MS, Wille-Jorgensen P. Survey of the use of thromboprophylaxis in laparoscopic surgery in Denmark. Br J Surg. 2001 Oct;88(10):1413-6. doi: 10.1046/j.0007-1323.2001.01856.x.
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.
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. doi: 10.1007/s004640090048. Epub 2001 Oct 5.
Prevention of venous thrombosis and pulmonary embolism. NIH Consensus Development. JAMA. 1986 Aug 8;256(6):744-9. No abstract available.
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. 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.
Other Identifiers
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CYYYMZ-004
Identifier Type: -
Identifier Source: org_study_id