-
The Cochrane Database of Systematic... Apr 2020Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane Review first published in 2010 and subsequently updated in 2012, twice in 2014, in 2017 and 2018.
OBJECTIVES
To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (7 July 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. Cluster-RCTs were eligible for inclusion, but we did not identify any. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross-over design. We included trials published in abstract form only if sufficient information was present in the abstract on methods and outcomes to analyze.
DATA COLLECTION AND ANALYSIS
At least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies.
MAIN RESULTS
We included 21 trials, reporting results for 7038 women evaluating the effects of vaginal cleansing (17 using povidone-iodine, 3 chlorhexidine, 1 benzalkonium chloride) on post-cesarean infectious morbidity. Trials used vaginal preparations administered by sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (17 trials) or the use of a saline vaginal preparation (4 trials). One trial did not report on any outcomes of interest. Trials were performed in 10 different countries (Saudi Arabia, Pakistan, Iran, Thailand, Turkey, USA, Egypt, UK, Kenya and India). The overall risk of bias was low for areas of attrition, reporting, and other bias. About half of the trials had low risk of selection bias, with most of the remainder rated as unclear. Due to lack of blinding, we rated performance bias as high risk in nearly one-third of the trials, low risk in one-third, and unclear in one-third. Vaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post-cesarean endometritis from 7.1% in control groups to 3.1% in vaginal cleansing groups (average risk ratio (aRR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; 20 trials, 6918 women; moderate-certainty evidence). This reduction in endometritis was seen for both iodine-based solutions and chlorhexidine-based solutions. Risks of postoperative fever and postoperative wound infection are also probably reduced by vaginal antiseptic preparation (fever: aRR 0.64, 0.50 to 0.82; 16 trials, 6163 women; and wound infection: RR 0.62, 95% CI 0.50 to 0.77; 18 trials, 6385 women; both moderate-certainty evidence). Two trials found that there may be a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82; 2 trials, 499 women; low-certainty evidence). No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing. Subgroup analysis suggested a greater effect with vaginal preparations for those women in labour versus those not in labour for four out of five outcomes examined (post-cesarean endometritis; postoperative fever; postoperative wound infection; composite wound complication or endometritis). This apparent difference needs to be investigated further in future trials. We did not observe any subgroup differences between women with ruptured membranes and women with intact membranes.
AUTHORS' CONCLUSIONS
Vaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis, postoperative fever, and postoperative wound infection. Subgroup analysis found that these benefits were typically present whether iodine-based or chlorhexidine-based solutions were used and when women were in labor before the cesarean. The suggested benefit in women in labor needs further investigation in future trials. There was moderate-certainty evidence using GRADE for all reported outcomes, with downgrading decisions based on limitations in study design or imprecision. As a simple intervention, providers may consider implementing preoperative vaginal cleansing with povidone-iodine or chlorhexidine before performing cesarean deliveries. Future research on this intervention being incorporated into bundles of care plans for women receiving cesarean delivery will be needed.
Topics: Administration, Intravaginal; Anti-Infective Agents, Local; Benzalkonium Compounds; Cesarean Section; Chlorhexidine; Disinfection; Endometritis; Female; Fever; Humans; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Wound Infection
PubMed: 32335895
DOI: 10.1002/14651858.CD007892.pub7 -
Surgical Innovation Feb 2016Retraction plays a vital role in optimizing the field of vision in minimal-access surgery. As such, a number of devices have been marketed to aid the surgeon in... (Review)
Review
BACKGROUND
Retraction plays a vital role in optimizing the field of vision in minimal-access surgery. As such, a number of devices have been marketed to aid the surgeon in laparoscopic retraction. This systematic review explores the advantages and disadvantages of the different instruments in order to aid surgeons and their institutions in selecting the appropriate device. Primary outcome measures include operation time, length of stay, use of staff, patient morbidity, ease of use, conversion rates to open surgery, and cost.
METHODS
Systematic literature searches were performed in MEDLINE, EMBASE, The Cochrane Library, Current Controlled Trials, and ClinicalTrials.gov. The search strategy focused on studies testing a retraction device. The selection process was based on a predefined set of inclusion and exclusion criteria. Data were then extracted and analyzed.
RESULTS
Out of 1360 papers initially retrieved, 12 articles were selected for data extraction and analysis. A total of 10 instruments or techniques were tested. Devices included the Nathanson's liver retractor, liver suspension tape, the V-List technique, a silicone disk with or without a snake retractor, the Endoloop, the Endograb, a magnetic retractor, the VaroLift, a laparoscope holder, and a retraction sponge. None of the instruments reported were associated with increased morbidity. No studies found increased rates of conversion to open surgery. All articles reported that the tested instruments might spare the use of an assistant during the procedure. It was not possible to determine the impact on length of stay or operation time.
CONCLUSIONS
Each analyzed device facilitates retraction, providing a good field of view while allowing reduced staff numbers and minimal patient morbidity. Due to economic and environmental advantages, reusable devices may be preferable to disposable instruments, although the choice must be primarily based on clinical judgement.
Topics: Humans; Laparoscopy; Surgical Instruments; Treatment Outcome
PubMed: 26025138
DOI: 10.1177/1553350615587991 -
The Cochrane Database of Systematic... Oct 2015Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterised by recurrent painful boils in flexural sites, such as the axillae and groin, that... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterised by recurrent painful boils in flexural sites, such as the axillae and groin, that affects about 1% of the population, with onset in early adulthood.
OBJECTIVES
To assess the effects of interventions for HS in people of all ages.
SEARCH METHODS
We searched the following databases up to 13 August 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 7, 2015), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched five trials registers and handsearched the conference proceedings of eight dermatology meetings. We checked the reference lists of included and excluded studies for further references to relevant trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of all interventions for hidradenitis suppurativa.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility and methodological quality and performed data extraction. Our primary outcomes were quality of life, measured by a validated dermatology-specific scale, and adverse effects of the interventions.
MAIN RESULTS
Twelve trials, with 615 participants, met our inclusion criteria. The median number of participants in each trial was 27, and median trial duration was 16 weeks. The included studies were conducted over a 32-year time period, from 1983 to 2015. A single RCT that was underpowered to detect clinically meaningful differences investigated most interventions.There were four trials of anti-TNF-α (tumour necrosis factor-alpha) therapies, which included etanercept, infliximab, and adalimumab. Adalimumab 40 mg weekly improved the Dermatology Life Quality Index (DLQI) score in participants with moderate to severe HS by 4.0 points relative to placebo (95% confidence interval (CI) -6.5 to -1.5 points), an effect size approximately equal to the DLQI minimal clinically important difference. We reduced the evidence quality to 'moderate' because the effect size was based on the results of only one study. In a meta-analysis of two studies with 124 participants, standard dose adalimumab 40 mg every other week was ineffective compared with placebo (moderate quality evidence). In a smaller study of 38 participants, of whom only 33 provided efficacy data, infliximab 5 mg/kg treatment improved DLQI by 8.4 DLQI points after eight weeks. Etanercept 50 mg twice weekly was well tolerated but ineffective.In a RCT of 200 participants, no difference was found in surgical complications (week one: risk ratio (RR) 0.78, 95% CI 0.58 to 1.05, moderate quality evidence) or risk of recurrence (after three months: RR 0.96, 95% CI 0.68 to 1.34, moderate quality evidence) in those randomised to receive a gentamicin-collagen sponge prior to primary closure compared with primary closure alone.RCTs of other interventions, including topical clindamycin 1% solution; oral tetracycline; oral ethinylestradiol 50 mcg with either cyproterone acetate 50 mg or norgestrel 500 mcg; intense pulsed light; neodymium-doped yttrium aluminium garnet (Nd:YAG) laser; methylene blue gel photodynamic therapy; and staphage lysate, were relatively small studies, preventing firm conclusions due to imprecision.
AUTHORS' CONCLUSIONS
Many knowledge gaps exist in RCT evidence for HS. Moderate quality evidence exists for adalimumab, which improves DLQI score when 40 mg is given weekly, twice the standard psoriasis dose. However, the 95% confidence interval includes an effect size of only 1.5 DLQI points, which may not be clinically relevant, and the safety profile of weekly dosing has not been fully established. Infliximab also improves quality of life, based on moderate quality evidence.More RCTs are needed in most areas of HS care, particularly oral treatments and the type and timing of surgical procedures. Outcomes should be validated, ideally, including a minimal clinically important difference for HS.
Topics: Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents; Female; Hidradenitis Suppurativa; Humans; Intense Pulsed Light Therapy; Laser Therapy; Male; Photochemotherapy; Phototherapy; Randomized Controlled Trials as Topic; Tumor Necrosis Factor-alpha
PubMed: 26443004
DOI: 10.1002/14651858.CD010081.pub2 -
JAMA Surgery Aug 2015Serious, preventable surgical events, termed never events, continue to occur despite considerable patient safety efforts. (Review)
Review
IMPORTANCE
Serious, preventable surgical events, termed never events, continue to occur despite considerable patient safety efforts.
OBJECTIVE
To examine the incidence and root causes of and interventions to prevent wrong-site surgery, retained surgical items, and surgical fires in the era after the implementation of the Universal Protocol in 2004.
DATA SOURCES
We searched 9 electronic databases for entries from 2004 through June 30, 2014, screened references, and consulted experts.
STUDY SELECTION
Two independent reviewers identified relevant publications in June 2014.
DATA EXTRACTION AND SYNTHESIS
One reviewer used a standardized form to extract data and a second reviewer checked the data. Strength of evidence was established by the review team. Data extraction was completed in January 2015.
MAIN OUTCOMES AND MEASURES
Incidence of wrong-site surgery, retained surgical items, and surgical fires.
RESULTS
We found 138 empirical studies that met our inclusion criteria. Incidence estimates for wrong-site surgery in US settings varied by data source and procedure (median estimate, 0.09 events per 10,000 surgical procedures). The median estimate for retained surgical items was 1.32 events per 10,000 procedures, but estimates varied by item and procedure. The per-procedure surgical fire incidence is unknown. A frequently reported root cause was inadequate communication. Methodologic challenges associated with investigating changes in rare events limit the conclusions of 78 intervention evaluations. Limited evidence supported the Universal Protocol (5 studies), education (4 studies), and team training (4 studies) interventions to prevent wrong-site surgery. Limited evidence exists to prevent retained surgical items by using data-matrix-coded sponge-counting systems (5 pertinent studies). Evidence for preventing surgical fires was insufficient, and intervention effects were not estimable.
CONCLUSIONS AND RELEVANCE
Current estimates for wrong-site surgery and retained surgical items are 1 event per 100,000 and 1 event per 10,000 procedures, respectively, but the precision is uncertain, and the per-procedure prevalence of surgical fires is not known. Root-cause analyses suggest the need for improved communication. Despite promising approaches and global Universal Protocol evaluations, empirical evidence for interventions is limited.
Topics: Clinical Protocols; Databases, Factual; Fires; Foreign Bodies; Humans; Incidence; Medical Errors; Patient Safety; Root Cause Analysis; United States
PubMed: 26061125
DOI: 10.1001/jamasurg.2015.0301 -
Techniques in Coloproctology Feb 2016Surgical site infections occur in up to 24 % of patients after surgical excision of sacrococcygeal pilonidal sinus disease with primary wound closure. Local... (Meta-Analysis)
Meta-Analysis Review
Local administration of gentamicin collagen sponge in surgical excision of sacrococcygeal pilonidal sinus disease: a systematic review and meta-analysis of the literature.
Surgical site infections occur in up to 24 % of patients after surgical excision of sacrococcygeal pilonidal sinus disease with primary wound closure. Local administration of antibiotics by a gentamicin collagen sponge could reduce this infection rate. The objective of this systematic review and meta-analysis was to evaluate the effect of a gentamicin collagen sponge on outcome after surgical excision in patients with sacrococcygeal pilonidal sinus disease. A structured literature search was performed in the PubMed, Embase, The Cochrane Library, and Scopus databases. Studies comparing surgical excision of sacrococcygeal pilonidal sinus disease with versus without a gentamicin collagen sponge were included. Outcome measures were surgical site infection, wound healing, and recurrence. The search strategy yielded six studies with a total of 669 patients. Three randomized controlled trials, comparing excision of pilonidal sinus disease and primary wound closure with versus without gentamicin collagen sponge, were eligible for inclusion in the meta-analysis (319 patients), demonstrating a trend towards reduced surgical site infections after administration of gentamicin collagen sponge [absolute risk reduction 20 %, 95 %-confidence interval (CI) 1-41 %, p = 0.06]. The wound healing (absolute risk reduction 22 %, 95 % CI 32-77 %, p = 0.42) and recurrence rate (absolute risk reduction 8 %, 95 % CI 7-22 %, p = 0.30) were not significantly different between both groups. Administration of a gentamicin collagen sponge after surgical excision of sacrococcygeal pilonidal sinus disease showed no significant influence on wound healing and recurrence rate, but a trend towards a reduced incidence of surgical site infections. Therefore, additional larger well-designed randomized controlled trials are required.
Topics: Administration, Topical; Anti-Bacterial Agents; Collagen; Follow-Up Studies; Gentamicins; Humans; Pilonidal Sinus; Randomized Controlled Trials as Topic; Recurrence; Sacrococcygeal Region; Surgical Sponges; Surgical Wound Infection; Wound Healing
PubMed: 26546004
DOI: 10.1007/s10151-015-1381-7 -
Vascular Health and Risk Management 2014TachoSil(®) is a medicated sponge coated with human fibrinogen and human thrombin. It is indicated as a support treatment in adult surgery to improve hemostasis,... (Review)
Review
BACKGROUND
TachoSil(®) is a medicated sponge coated with human fibrinogen and human thrombin. It is indicated as a support treatment in adult surgery to improve hemostasis, promote tissue sealing, and support sutures when standard surgical techniques are insufficient. This review systematically analyses the international scientific literature relating to the use of TachoSil in hemostasis and as a surgical sealant, from the point of view of its economic impact.
METHODS
We carried out a systematic review of the PubMed literature up to November 2013. Based on the selection criteria, papers were grouped according to the following outcomes: reduction of time to hemostasis; decrease in length of hospital stay; and decrease in postoperative complications.
RESULTS
Twenty-four scientific papers were screened, 13 (54%) of which were randomized controlled trials and included a total of 2,116 patients, 1,055 of whom were treated with TachoSil. In the clinical studies carried out in patients undergoing hepatic, cardiac, or renal surgery, the time to hemostasis obtained with TachoSil was lower (1-4 minutes) than the time measured with other techniques and hemostatic drugs, with statistically significant differences. Moreover, in 13 of 15 studies, TachoSil showed a statistically significant reduction in postoperative complications in comparison with the standard surgical procedure. The range of the observed decrease in the length of hospital stay for TachoSil patients was 2.01-3.58 days versus standard techniques, with a statistically significant difference in favor of TachoSil in eight of 15 studies.
CONCLUSION
This analysis shows that TachoSil has a role as a supportive treatment in surgery to improve hemostasis and promote tissue sealing when standard techniques are insufficient, with a consequent decrease in postoperative complications and hospital costs.
Topics: Blood Loss, Surgical; Cost-Benefit Analysis; Drug Combinations; Drug Costs; Fibrinogen; Hemostatic Techniques; Hemostatics; Hospital Costs; Humans; Length of Stay; Outcome and Process Assessment, Health Care; Postoperative Hemorrhage; Thrombin; Time Factors; Treatment Outcome
PubMed: 25246797
DOI: 10.2147/VHRM.S63199 -
The Journal of Laryngology and Otology Jun 2018A systematic review was conducted to investigate the effectiveness of fibroblast growth factor-2 on the regeneration of tympanic membrane perforation. (Review)
Review
OBJECTIVE
A systematic review was conducted to investigate the effectiveness of fibroblast growth factor-2 on the regeneration of tympanic membrane perforation.
METHODS
The PubMed database was searched for relevant studies. Experimental studies, human randomised controlled trials, prospective single-arm studies and retrospective studies reporting acute and chronic tympanic membrane perforations in relation to two healing outcomes (success rate and closure time), were selected.
RESULTS
All 11 clinical studies investigating the effect of fibroblast growth factor-2 on traumatic tympanic membrane perforations in humans reported a success rate of 89.3-100 per cent, with a closure time of around 2 weeks. Three studies of fibroblast growth factor-2 combined with Gelfoam showed that the success rate of chronic tympanic membrane perforation was 83-98.1 per cent in the fibroblast growth factor-2 group, but 10 per cent in the gelatine sponge groups.
CONCLUSION
Fibroblast growth factor-2 with or without biological material patching promotes regeneration in cases of acute and chronic tympanic membrane perforation, and is safe and efficient. However, the best dosage, application time and administration pathway of fibroblast growth factor-2 are still to be elucidated.
Topics: Chronic Disease; Fibroblast Growth Factor 2; Gelatin Sponge, Absorbable; Hemostatics; Humans; Regeneration; Treatment Outcome; Tympanic Membrane; Tympanic Membrane Perforation
PubMed: 30019671
DOI: 10.1017/S002221511800083X -
World Neurosurgery Aug 2018Retention of nonabsorbable hemostatic materials (RNHMs), that is, retained surgical sponge, gauzoma, gossypiboma, muslinoma, or textiloma, is a rarely seen surgical... (Review)
Review
Retention of Nonabsorbable Hemostatic Materials (Retained Surgical Sponge, Gossypiboma, Textiloma, Gauzoma, Muslinoma) After Spinal Surgery: A Systematic Review of Cases Reported During the Last Half-Century.
OBJECTIVE
Retention of nonabsorbable hemostatic materials (RNHMs), that is, retained surgical sponge, gauzoma, gossypiboma, muslinoma, or textiloma, is a rarely seen surgical complication after spinal surgery that may remain asymptomatic for many years and may represent a diagnostic difficulty with associated medicolegal implications.
METHODS
We performed a systematic review of the English-language literature published between 1965 and 2017, accessed through 4 popular databases. We found a total of 37 articles (24 case reports; 7 image presentations; 5 clinical series, and 1 letter to editor) containing 58 cases of RNHMs located within the spinal canal or around the spinal column after surgery.
RESULTS
In this study, there were 29 female and 29 male patients from 13 countries, ages ranging from 17 years to 87 years, with initial diagnoses of lumbar or cervical disc herniation, spinal stenosis, or spondylolisthesis (n = 54), or spinal tumor (n = 4). The interval from the initial surgery to the presentation of RNHMs ranged from 13 days to 40 years, with a mean of 75.9 months. Various imaging techniques such as computed tomography and magnetic resonance imaging were used with histologic study, confirming the presence of RNHMs in the majority of patients with a complete recovery resulting in 93% of patients.
CONCLUSIONS
RNHMs is an overreported entity in underdeveloped or developing countries, including Turkey and Morocco, with progression occurring over years. RNHMs should be considered in the differential diagnosis of any patient who presents with back pain, spinal cord, or nerve roots symptomatology after spinal surgery.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Foreign Bodies; Humans; Laminectomy; Middle Aged; Neurosurgical Procedures; Retrospective Studies; Spinal Cord Injuries; Young Adult
PubMed: 29807184
DOI: 10.1016/j.wneu.2018.05.119 -
Obstetrics and Gynecology Sep 2017To assess the efficacy of vaginal cleansing before cesarean delivery in reducing postoperative endometritis. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To assess the efficacy of vaginal cleansing before cesarean delivery in reducing postoperative endometritis.
DATA SOURCES
MEDLINE, Ovid, EMBASE, Scopus, Clinicaltrials.gov, and Cochrane Library were searched from their inception to January 2017.
METHODS OF STUDY SELECTION
Selection criteria included all randomized controlled trials comparing vaginal cleansing (ie, intervention group) with a control group (ie, either placebo or no intervention) in women undergoing cesarean delivery. Any method of vaginal cleansing with any type of antiseptic solution was included. The primary outcome was the incidence of endometritis. Meta-analysis was performed using the random-effects model of DerSimonian and Laird to produce summary treatment effects in terms of relative risk (RR) with 95% CI.
TABULATION, INTEGRATION, AND RESULTS
Sixteen trials (4,837 women) on vaginal cleansing immediately before cesarean delivery were identified as relevant and included in the review. In most of the included studies, 10% povidone-iodine was used as an intervention. The most common way to perform the vaginal cleansing was the use of a sponge stick for approximately 30 seconds. Women who received vaginal cleansing before cesarean delivery had a significantly lower incidence of endometritis (4.5% compared with 8.8%; RR 0.52, 95% CI 0.37-0.72; 15 studies, 4,726 participants) and of postoperative fever (9.4% compared with 14.9%; RR 0.65, 95% CI 0.50-0.86; 11 studies, 4,098 participants) compared with the control group. In the planned subgroup analyses, the reduction in the incidence of endometritis with vaginal cleansing was limited to women in labor before cesarean delivery (8.1% compared with 13.8%; RR 0.52, 95% CI 0.28-0.97; four studies, 440 participants) or those with ruptured membranes (4.3% compared with 20.1%; RR 0.23, 95% CI 0.10-0.52; three studies, 272 participants).
CONCLUSION
Vaginal cleansing immediately before cesarean delivery in women in labor and in women with ruptured membranes reduces the risk of postoperative endometritis. Because it is generally inexpensive and a simple intervention, we recommend preoperative vaginal preparation before cesarean delivery in these women with sponge stick preparation of povidone-iodine 10% for at least 30 seconds. More data are needed to assess whether this intervention may be also useful for cesarean deliveries performed in women not in labor and for those without ruptured membranes.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO International prospective register of systematic reviews, https://www.crd.york.ac.uk/PROSPERO/, CRD42017054843.
Topics: Administration, Intravaginal; Anti-Infective Agents, Local; Cesarean Section; Female; Humans; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Wound Infection; Vagina
PubMed: 28796683
DOI: 10.1097/AOG.0000000000002167 -
The Cochrane Database of Systematic... Feb 2023Vascular surgery may be followed by internal bleeding due to inadequate surgical haemostasis, abnormal clotting, or surgical complications. Bleeding ranges from minor,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vascular surgery may be followed by internal bleeding due to inadequate surgical haemostasis, abnormal clotting, or surgical complications. Bleeding ranges from minor, with no transfusion requirement, to massive, requiring multiple blood product transfusions. There are a number of drugs, given systemically or applied locally, which may reduce the need for blood transfusion.
OBJECTIVES
To assess the effectiveness and safety of anti-fibrinolytic and haemostatic drugs and agents in reducing bleeding and the need for blood transfusion in people undergoing major vascular surgery or vascular procedures with a risk of moderate or severe (> 500 mL) blood loss.
SEARCH METHODS
We searched: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL, and Transfusion Evidence Library. We also searched the WHO ICTRP and ClinicalTrials.gov trial registries for ongoing and unpublished trials. Searches used a combination of MeSH and free text terms from database inception to 31 March 2022, without restriction on language or publication status.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in adults of drug treatments to reduce bleeding due to major vascular surgery or vascular procedures with a risk of moderate or severe blood loss, which used placebo, usual care or another drug regimen as control.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were units of red cells transfused and all-cause mortality. Our secondary outcomes included risk of receiving an allogeneic blood product, risk of reoperation or repeat procedure due to bleeding, risk of a thromboembolic event, risk of a serious adverse event and length of hospital stay. We used GRADE to assess certainty of evidence.
MAIN RESULTS
We included 22 RCTs with 3393 participants analysed, of which one RCT with 69 participants was reported only in abstract form, with no usable data. Seven RCTs evaluated systemic drug treatments (three aprotinin, two desmopressin, two tranexamic acid) and 15 RCTs evaluated topical drug treatments (drug-containing bioabsorbable dressings or glues), including fibrin, thrombin, collagen, gelatin, synthetic sealants and one investigational new agent. Most trials were conducted in high-income countries and the majority of the trials only included participants undergoing elective surgery. We also identified two ongoing RCTs. We were unable to perform the planned network meta-analysis due to the sparse reporting of outcomes relevant to this review. Systemic drug treatments We identified seven trials of three systemic drugs: aprotinin, desmopressin and tranexamic acid, all with placebo controls. The trials of aprotinin and desmopressin were small with very low-certainty evidence for all of our outcomes. Tranexamic acid versus placebo was the systemic drug comparison with the largest number of participants (2 trials; 1460 participants), both at low risk of bias. The largest of these included a total of 9535 individuals undergoing a number of different higher risk surgeries and reported limited information on the vascular subgroup (1399 participants). Neither trial reported the number of units of red cells transfused per participant up to 30 days. Three outcomes were associated with very low-certainty evidence due to the very wide confidence intervals (CIs) resulting from small study sizes and low number of events. These were: all-cause mortality up to 30 days; number of participants requiring an allogeneic blood transfusion up to 30 days; and risk of requiring a repeat procedure or operation due to bleeding. Tranexamic acid may have no effect on the risk of thromboembolic events up to 30 days (risk ratio (RR) 1.10, 95% CI 0.88 to 1.36; 1 trial, 1360 participants; low-certainty evidence due to imprecision). There is one large ongoing trial (8320 participants) comparing tranexamic acid versus placebo in people undergoing non-cardiac surgery who are at high risk of requiring a red cell transfusion. This aims to complete recruitment in April 2023. This trial has primary outcomes of proportion of participants transfused with red blood cells and incidence of venous thromboembolism (DVT or PE). Topical drug treatments Most trials of topical drug treatments were at high risk of bias due to their open-label design (compared with usual care, or liquids were compared with sponges). All of the trials were small, most were very small, and few reported clinically relevant outcomes in the postoperative period. Fibrin sealant versus usual care was the topical drug comparison with the largest number of participants (5 trials, 784 participants). The five trials that compared fibrin sealant with usual care were all at high risk of bias, due to the open-label trial design with no measures put in place to minimise reporting bias. All of the trials were funded by pharmaceutical companies. None of the five trials reported the number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. The other three outcomes were associated with very low-certainty evidence with wide confidence intervals due to small sample sizes and the low number of events, these were: all-cause mortality up to 30 days; risk of requiring a repeat procedure due to bleeding; and risk of thromboembolic disease up to 30 days. We identified one large trial (500 participants) comparing fibrin sealant versus usual care in participants undergoing abdominal aortic aneurysm repair, which has not yet started recruitment. This trial lists death due to arterial disease and reintervention rates as primary outcomes.
AUTHORS' CONCLUSIONS
Because of a lack of data, we are uncertain whether any systemic or topical treatments used to reduce bleeding due to major vascular surgery have an effect on: all-cause mortality up to 30 days; risk of requiring a repeat procedure or operation due to bleeding; number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. There may be no effect of tranexamic acid on the risk of thromboembolic events up to 30 days, this is important as there has been concern that this risk may be increased. Trials with sample size targets of thousands of participants and clinically relevant outcomes are needed, and we look forward to seeing the results of the ongoing trials in the future.
Topics: Adult; Humans; Aprotinin; Blood Transfusion; Deamino Arginine Vasopressin; Fibrin Tissue Adhesive; Hemorrhage; Network Meta-Analysis; Tranexamic Acid
PubMed: 36800489
DOI: 10.1002/14651858.CD013649.pub2