METHODS: This is a pragmatic randomized control trial study where elective admitted patients will be randomly divided into the intervention (SS) or control (NN) group. All data will be collected during a face-to-face interview, anthropometric measurement, blood sampling (albumin, white blood count, hemoglobin, and c-reactive protein), handgrip strength, and postoperative complications. Group SS will be receiving a tailored lifestyle and intensively supplemented with oral nutrition support as compared to Group NN that will receive standard medical care. The primary outcome for this study is the length of stay in the hospital. Additional outcome measures are changes in biochemical profile and nutritional and functional status. The effects of intervention between groups on the outcome parameters will be analyzed by using the SPSS General Linear Model (GLM) for the repeated measure procedure.
DISCUSSION: The intervention implemented in this study will serve as baseline data in providing appropriate nutritional management in patients undergoing gastrointestinal and oncological surgery.
TRIAL REGISTRATION: ClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04347772 . Registered on 20 November 2019.
METHODS: POISE-2 was a blinded, randomized trial of patients having non-cardiac surgery. Patients were assigned to perioperative aspirin or placebo. The primary outcome was a composite of death or myocardial infarction at 30 days. Secondary outcomes included: vascular occlusive complications (a composite of amputation and peripheral arterial thrombosis) and major or life-threatening bleeding.
RESULTS: Of 10 010 patients in POISE-2, 603 underwent vascular surgery, 319 in the continuation and 284 in the initiation stratum. Some 272 patients had vascular surgery for occlusive disease and 265 had aneurysm surgery. The primary outcome occurred in 13·7 per cent of patients having aneurysm repair allocated to aspirin and 9·0 per cent who had placebo (hazard ratio (HR) 1·48, 95 per cent c.i. 0·71 to 3·09). Among patients who had surgery for occlusive vascular disease, 15·8 per cent allocated to aspirin and 13·6 per cent on placebo had the primary outcome (HR 1·16, 0·62 to 2·17). There was no interaction with the primary outcome for type of surgery (P = 0·294) or aspirin stratum (P = 0·623). There was no interaction for vascular occlusive complications (P = 0·413) or bleeding (P = 0·900) for vascular compared with non-vascular surgery.
CONCLUSION: This study suggests that the overall POISE-2 results apply to vascular surgery. Perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications. Registration number: NCT01082874 ( http://www.clinicaltrials.gov).
OBJECTIVE: The present study investigated the effectiveness of chewing gum on promoting faster bowel function and its ability to hasten recovery for patients with adolescent idiopathic scoliosis (AIS) after posterior spinal fusion (PSF) surgery.
SUMMARY OF BACKGROUND DATA: Sham feeding with chewing gum had been reported to reduce the incidence of postoperative ileus by accelerating recovery of bowel function.
METHODS: We prospectively recruited and randomized 60 patients with AIS scheduled for PSF surgery into treatment (chewing gum) and control group. The patient-controlled anesthesia usage, wound pain score, abdominal pain score, nausea score, and abdominal girth were assessed and recorded at 12, 24, 36, 48, and 60 hours postoperatively. The timing for the first fluid intake, first oral intake, sitting up, walking, first flatus after surgery, first bowel opening after surgery, and duration of hospital stay were also assessed and recorded.
RESULTS: We found that there were no significant differences (P > 0.05) in patient-controlled anesthesia usage, wound pain score, abdominal pain score, nausea score, and abdominal girth between treatment (chewing gum) and control groups. We also found that there were no significant difference (P > 0.05) in postoperative recovery parameters, which were the first fluid intake, first oral intake, sitting up after surgery, walking after surgery, first flatus after surgery, first bowel opening after surgery, and duration of hospital stay between both groups. The wound pain was the worst at 12 hours postoperatively, which progressively improved in both groups. The abdominal pain progressively worsened to the highest score at 48 hours in the treatment group and 36 hours in the control group before improving after that. The pattern of severity and recovery of wound pain and abdominal pain was different.
CONCLUSION: We found that chewing gum did not significantly reduce the abdominal pain, promote faster bowel function, or hasten patient recovery.
LEVEL OF EVIDENCE: 1.
METHODS: Four electronic full-text databases were systematically searched through September 2017. Data including outcomes of annular closure device/annular repair were extracted. All results were pooled utilising meta-analysis with weighted mean difference and odds ratio as summary statistics.
RESULTS: Four studies met inclusion criteria. Three studies reported the use of Barricaid (ACD) while one study reported the use of Anulex (AR). A total of 24 symptomatic reherniation were reported among 811 discectomies with ACD/AR as compared to 51 out of 645 in the control group (OR: 0.34; 95% CI: 0.20,0.56; I2 = 0%; P control group (OR: 0.54; 95% CI: 0.13, 2.23; I2 = 11%; P = 0.39). Similar outcomes for post-operative Oswestry Disability Index and visual analogue scale were obtained when both groups were compared.
CONCLUSION: Early results showed the use of Barricaid and Anulex devices are beneficial for short term outcomes demonstrating reduction in symptomatic disc reherniation with low post-operative complication rates. Long-term studies are required to further investigate the efficacy of such devices.
METHODS AND RESULTS: The 'COlchicine for the Prevention of Perioperative Atrial Fibrillation' (COP-AF) trial is an international, blinded, randomized trial that compares colchicine to placebo in patients aged at least 55 years and undergoing major noncardiac thoracic surgery with general anesthesia. Exclusion criteria include a history of AF and a contraindication to colchicine (eg, severe renal dysfunction). Oral colchicine at a dose of 0.5 mg or matching placebo is given within 4 hours before surgery. Thereafter, patients receive colchicine 0.5 mg or placebo twice daily for a total of 10 days. The 2 independent co-primary outcomes are clinically important perioperative AF (including atrial flutter) and MINS during 14 days of follow-up. The main safety outcomes are sepsis or infection and non-infectious diarrhea. We aim to enroll 3,200 patients from approximately 40 sites across 11 countries to have at least 80% power for the independent evaluation of the 2 co-primary outcomes. The COP-AF main results are expected in 2023.
CONCLUSIONS: COP-AF is a large randomized and blinded trial designed to determine whether colchicine reduces the risk of perioperative AF or MINS in patients who have major noncardiac thoracic surgery.
OBJECTIVE: The primary objective of this study was to develop a new LSM scoring system and investigate the correlation between adherence to LSM and incidence of major adverse cardiac events (MACEs) at 12-month follow-up.
METHOD: A total of 1000 consecutive patients who underwent percutaneous transluminal coronary angioplasty (PTCA) were included in this prospective single-center study. Manipal lifestyle modification score (MLSMS) was developed by using five lifestyle-related factors. Adherence to LSM at the baseline and subsequent follow-ups was determined by using MLSMS. The MACE at 1-, 6-, and 12-month follow-up were analyzed.
RESULTS: There was a significant reduction in overall adherence to LSM (p
OBJECTIVE: To investigate what type of flap used during Snodgrass or fistula repair reduces the incidence of fistula occurrence.
EVIDENCE ACQUISITION: We systematically reviewed published results for urethral covering during Snodgrass and fistula repair procedures. An initial online search detected 1740 reports. After exclusion of ineligible studies at two stages, we included all patients with clear data on the covering technique used (dartos fascia [DF] vs tunica vaginalis flap [TVF]) and the incidence of postoperative fistula.
EVIDENCE SYNTHESIS: A total of 51 reports were identified involving 4550 patients, including 33 series on DF use, 11 series on TVF use, and seven retrospective comparative studies. For distal hypospadias, double-layer DF had the lowest rate of fistula incidence when compared to single-layer DF (5/855 [0.6%] vs 156/3077 [5.1%]; p=0.004) and TVF (5/244, 2.0%), while the incidence was highest for single-layer DF among proximal hypospadias cases (9/102, 8.8%). Among repeat cases, fistula incidence was significantly lower for TVF (3/47, 6.4%) than for DF (26/140, 18.6%; p=0.020). Among patients with fistula after primary repair, the incidence of recurrence was 12.2% (11/90) after DF and 5.1% (5/97) after TVF (p=0.39). The absence of a minimum follow-up time and the lack of information regarding skin complications and rates of urethral stricture are limitations of this study.
CONCLUSION: A double DF during tubularized incised plate urethroplasty should be considered for all patients with distal hypospadias. In proximal, repeat, and fistula repair cases, TVF should be the first choice. On the basis of these findings, we propose an evidence-based algorithm for surgeons who are still in their learning phase or want to improve their results.
PATIENT SUMMARY: We systematically reviewed the impact of urethral covering in reducing fistula formation after hypospadias repair. We propose an algorithm that might help to maximize success rates for tubularized incised plate urethroplasty.
METHODS: A meta-analysis and systematic review of MEDLINE, PubMed Central (via PubMed), Embase (via Ovid), SCOPUS, ScienceDirect, Google Scholar, SCI and Cochrane Library databases were undertaken. Seven randomized controlled trials assessing the outcomes of PSR and POMR were analyzed in accordance with the PRISMA statement. The risk of bias was assessed using the Rob2 tool.
RESULTS: According to the pooled analysis, POMR significantly reduced the incidence of IH compared to the PSR (OR 5.82 [95% CI 2.69, 12.58] P
METHODS: This was a randomized control, open-label trial. Women underwent major gynecological surgery were randomized to receive either subcutaneous 50 mg of Na-PPS twice daily or subcutaneous enoxaparin 40 mg once daily. Fondaparinux 2.5 mg once daily was given to Muslim women as an alternative to enoxaparin. The treatment was started 6 h postoperatively, for at least 3 days. All the patients received thromboembolic deterrent stockings. The primary efficacy outcome was venous thromboembolism up to 3 days postsurgery. The main safety outcomes were minor and major bleeding.
RESULTS: Among 109 participants, there was no incidence of venous thromboembolism. None of the women developed major bleeding. Minor bleeding was observed in 28.3% (15/53) and 5.4% (3/56) of Na-PPS and standard thromboprophylaxis group, respectively (P = 0.001).
CONCLUSION: Na-PPS was associated with increased risk of minor bleeding. There was insufficient data to conclude its efficacy as thromboprophylaxis. Further research is needed to evaluate Na-PPS safety as a standard thromboprophylactic agent.
METHOD: A prospective, randomized, double-blinded controlled trial was conducted with 58 patients undergoing breast conserving surgery (BCS) and ALND, stratified into two groups: Group A (ALND + Haemoblock, n = 29) and Group B (ALND + placebo, n = 29). Postoperative drainage charts were monitored, with the primary endpoint being the time to drain removal, Additionally, patients were observed for surgical site infection (SSI).
RESULTS: Group A exhibited a marginally higher mean total drain output (398 +/- 205 vs. 326 +/- 198) compared to Group B, this difference did not attain statistical significance (p = 0.176). Equally, the mean time to drain removal demonstrated no discernible distinction between the two groups (6 +/- 3.0 vs. 6 +/- 3.0, Group A vs. Group B, p = 0.526). During follow up, nine patients in Group A required seroma aspiration (mean aspiration 31 +/- 73) as compared to Group B, 6 patients required aspiration (mean aspiration 12 +/- 36), p = 0.222). No notable disparity in SSI rates between the groups was identified.
CONCLUSION: In conclusion, the administration of Haemoblock did not manifest a discernible effect in mitigating seroma production, hastening drain removal, or influencing SSI rates following ALND. The study underscores the intricate and multifactorial nature of seroma formation, suggesting avenues for future research to explore combined interventions and protracted follow-up periods for a more comprehensive understanding.