Detection and Prevention of Post-Operative Deep Vein Thrombosis [DVT] Using Nadroparin Among Patients Undergoing Major Abdominal Operations in India; a Randomised Controlled Trial

Abstract

Deep vein thrombosis [DVT] is one of the most dreaded complications in post-operative patients as it is associated with considerable morbidity and mortality. Majority of patients with postoperative DVT are asymptomatic. The pulmonary embolism, which is seen in 10% of the cases with proximal DVT, may be fatal. Therefore it becomes imperative to prevent DVT rather than to diagnose and treat. Only one randomized trial has been reported from India to assess the effectiveness of low molecular weight heparin in preventing post-operative DVT. To assess the risk of DVT in North Indian patients following major abdominal operations and to evaluate the effectiveness of Nadroparin, A Low Molecular Weight Heparin (LMWH) therapy in preventing post-operative DVT. Sixty five patients were randomised preoperatively into Group-I; Nadroparin prophylaxis and Group-II: No prophylaxis. The primary outcome was the occurrence of DVT, diagnosed by bilateral lower limb venogram performed, seven to ten days after operation. Secondary outcome measures included adverse effects of radio-opaque dye, intra-operative blood loss, operating time, postoperative platelet count, intraoperative blood transfusion requirements and the total duration of postoperative bed rest. No case of DVT occurred in either group. There was no statistical difference in the risk of secondary outcome measures in the two groups. DVT was not observed in any of the patients, even with several high risk factors indicating a possible protective mechanism in the North Indian population.

DVT Prophylaxis- Is It Mandatory for Major General Surgical Operations?

“…A prospective study done on major abdominal surgery patients from India reports negative incidence of DVT in both treatment and control arm. 10 Method used to detect DVT was lower limb venography. A trial from Tata Memorial Cancer Center was stopped prematurely due to nonincidence of DVT after examining 50 patients in prophylaxis group and 49 patients in control group.…”

Deep Vein Thrombosis in Indian Cancer Patients Undergoing Major Thoracic and Abdomino-Pelvic Surgery

“…Most of the patients belonged to AJCC/TNM stage II and III, and all underwent curative resection. Two randomized controlled trials (RCTs) published from India showed negligible incidence of DVT after major abdominal and colorectal cancer surgery [13,14]. A RCT conducted to assess the risk of DVT in North Indian patients undergoing major abdominal surgery reported that none of the 65 patients Postoperative death (sepsis and multi organ failure) 1 (0.…”

“…A RCT conducted to assess the risk of DVT in North Indian patients undergoing major abdominal surgery reported that none of the 65 patients Postoperative death (sepsis and multi organ failure) 1 (0. 4 %) in two treatment arms developed DVT; Nadroparin prophylaxis was prescribed in 34 patients while 31 had no prophylaxis [13]. Another RCT performed at Tata Memorial Hospital was prematurely closed as none of the 99 colorectal cancer patients who underwent curative surgery (both prophylaxis and no prophylaxis group) were found to develop DVT [14].…”

“…Another RCT performed at Tata Memorial Hospital was prematurely closed as none of the 99 colorectal cancer patients who underwent curative surgery (both prophylaxis and no prophylaxis group) were found to develop DVT [14]. These studies highlighted that the Indian patients have low risk of development of postoperative DVT [13][14][15]. The reasons for the low frequency of postoperative DVT among the Indian patients may be related to racial, genetic or rheological factors.…”

“…They also concluded that clinical assessment of prior probability of VTE should probably be adjusted based on ethnic differences [15,16 ]. There is need of further studies to clarify the possible decreased prevalence of factor V Leiden mutation and G20210 A mutation in the Indians which may explain the relative immunity of the Indian patients for DVT [13]. Other reasons for low incidence of postoperative DVT in our patient cohort may include good preoperative performance status of the patients, resectable stage of the tumours, meticulous surgical techniques, and early post-operative ambulation.…”