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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 -
Techniques in Coloproctology Jul 2020The aim of this study was to assess the efficacy of an endoluminal vacuum device (Endo-SPONGE) in the treatment of rectal anastomotic leaks. (Review)
Review
BACKGROUND
The aim of this study was to assess the efficacy of an endoluminal vacuum device (Endo-SPONGE) in the treatment of rectal anastomotic leaks.
METHODS
All studies looking at endoluminal vacuum therapy with Endo-SPONGE in the treatment of rectal anastomotic leaks were included. A comprehensive search was conducted as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Primary outcome was defined as the rate of total anastomotic salvage, with secondary outcomes including rate of ileostomy closure, additional transrectal closures and functional outcomes RESULTS: Sixteen studies met the inclusion criteria. There was a significant publication bias (z = 3.53, p = 0.0004). Two hundred sixty-six patients were identified. The median treatment failure rate was 11.8% (range 0-44%), with random effects model of 0.17 (95% CI 0.11-0.22). There was improvement with early therapy start (OR 3.48) and negative correlation with neoadjuvant radiotherapy (OR 0.56). Fifty-one percent of all diverting stomas were closed at the end of treatment period and 12.8% of patients required an additional trans-rectal closure of the abscess cavity.
CONCLUSIONS
Endo-SPONGE seems to be a useful method of rectal anastomotic leak treatment in selected group of patients; however, the quality of available data is poor and it is impossible to draw a final conclusion. There is unexpected high rate of permanent ileostomy. There is a need for further assessment of this therapy with well-designed randomised or cohort studies.
Topics: Anastomosis, Surgical; Anastomotic Leak; Female; Humans; Ileostomy; Rectal Neoplasms; Rectum; Surgical Stomas; Treatment Outcome
PubMed: 32377984
DOI: 10.1007/s10151-020-02200-1 -
Journal of Thoracic Disease Feb 2023Pleural empyema is a serious and potentially deadly disease leading to a significant burden on health care systems. Conservative and surgical treatment results remain... (Review)
Review
BACKGROUND
Pleural empyema is a serious and potentially deadly disease leading to a significant burden on health care systems. Conservative and surgical treatment results remain poor, with high morbidity and mortality rates. Patients with pleural empyema are often multimorbid and poor candidates for surgery. Therefore, it appears sensible to explore alternative, less invasive treatment options. Recently, the well-established vacuum sponge therapy has been adopted in the treatment of pleural infections. The goal of this systematic review was to identify the existing literature and reported results of vacuum therapy for pleural empyema.
METHODS
A systematic search of MEDLINE and the Cochrane Database was performed independently by two reviewers using predefined criteria according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. In addition, abstracts from selected conference proceedings were screened and reference scanning of the search results was performed. Single case reports were excluded.
RESULTS
Fourteen studies met the selection criteria and were reviewed. A total of 165 patients were treated with vacuum therapy in the studies reviewed. 61.2% of the patients had pleural empyema secondary to thoracic surgery. In 71.5% of the patients, vacuum therapy was applied following open window thoracostomy (OWT). Mortality rates of 0-33% were reported for vacuum therapy after OWT and 0-9.3% for vacuum therapy without OWT. Length of hospital stay (LOHS) ranged from 44-217 days for patients after OWT and could not be analysed for vacuum therapy without OWT due to lacking data. Median treatment time was 7-14 days. Treatment related complications were rare overall. Success rates defined as infection resolution were high irrespective of previous treatment and cause of empyema.
CONCLUSIONS
The current literature shows that pleural vacuum therapy is a promising, safe, and feasible treatment alternative to existing treatment modalities for pleural empyema. However, the evidence for vacuum therapy without OWT is poor, and further data, optimally prospective or randomised control trials comparing the conventional surgical approach of video-assisted thoracoscopic surgery (VATS) decortication and minimally invasive vacuum therapy, are needed.
PubMed: 36910103
DOI: 10.21037/jtd-22-1188 -
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 -
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 -
Journal of Personalized Medicine Oct 2022Fournier's gangrene (FG) is a Necrotizing Soft Tissue Infection (NSTI) of the perineal region characterized by high morbidity and mortality even if appropriately... (Review)
Review
Fournier's gangrene (FG) is a Necrotizing Soft Tissue Infection (NSTI) of the perineal region characterized by high morbidity and mortality even if appropriately treated. The main treatment strategies are surgical debridement, broad-spectrum antibiotics, hyperbaric oxygen therapy, NPWT (Negative Pressure Wound Therapy), and plastic surgery reconstruction. We present the case of a 50-year-old woman with an NSTI of the abdomen, pelvis, and perineal region associated with a rectal fistula referred to our department. After surgical debridement and a diverting blow-out colostomy, an NPWT system composed of two sponges connected by a bridge through a rectal fistula was performed. Our target was to obtain healing in a lateral-to-medial direction instead of depth-to-surface to prevent the enlargement of the rectal fistula, promoting granulation tissue growth towards the rectum. This eso-endo-NPWT technique allowed for the primary suture of the perineal wounds bilaterally, simultaneously treating the rectal fistula and the perineum lesions. A systematic review of the literature underlines the spreading of NPWT and its effects.
PubMed: 36294834
DOI: 10.3390/jpm12101695 -
Techniques in Coloproctology Aug 2018Among the techniques investigated to reduce the risk of surgical wound infection or surgical space infection (SSI) in patients having colorectal surgery are topical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Among the techniques investigated to reduce the risk of surgical wound infection or surgical space infection (SSI) in patients having colorectal surgery are topical application of antimicrobials (antibiotics and antiseptics) to the open wound or immediately after closure. The aim of the present study was to perform a systematic review of the literature on those treatments, with the exception of antibiotic ointments applied to closed skin, which are adequately assessed elsewhere, and a meta-analysis.
METHODS
Only randomized trials of patients having only colorectal surgery were included in this review. Studies were sought in MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, Clinical Trials.gov, and the World Health Organization Internet clinical trials register portal. In addition, reference lists of included studies and other published reviews were screened. Meta-analysis was performed for all included studies and subgroup analyses done for each individual intervention. Risk of bias was assessed for each included study, paying particular attention to the preoperative antibiotic prophylaxis used in each study. Sensitivity analyses were done to investigate heterogeneity of the analyses, excluding those studies with a significant risk of bias issues. Absolute risk reduction (RR) was calculated. The overall quality of the evidence for each individual intervention was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, and was classified as high, moderate, low or very low.
RESULTS
A total of 30 studies are included in this review with 5511 patients, 665 of whom had SSI. The interventions included: 10 studies of gentamicin impregnated sponge or beads wound inlays, 4 studies of chlorhexidine impregnated suture, 11 studies of direct wound lavage or powder application or injection of antibiotics before closure, 4 studies of ionized silver dressing applied to the closed skin, and 1 study of vitamin E oil applied to the open wound. All but one study used preoperative antibiotic prophylaxis in addition to topical procedures, although, in some studies, the systemic antibiotic prophylaxis was not the same between groups or varied significantly from the recommended guidelines. Use of gentamycin sponge did not decrease SSI (RR 0.93, 95% CI 0.75-1.16; low-quality evidence) even after including only the studies of abdominal wounds (RR 1.02, 95% CI 0.80-1.30; low-quality evidence). However, sensitivity analysis excluding studies at high risk of bias decreased the heterogeneity and increased the effect of the prophylaxis for all wounds (RR 0.5, 95% CI 0.33-0.78; low-quality evidence) and for abdominal wounds only (RR 0.38, 95% CI 0.20-0.72; moderate-quality evidence). Chlorhexidine impregnated suture showed no effect on SSI (RR 0.79, 95% CI 0.56-1.10; low-quality evidence) and an increased efficacy after sensitivity analysis (RR 0.42, 95% CI 0.22-0.79; low-quality evidence). Antibiotic lavage showed a significant decrease in SSI (RR 0.45, 95% CI 0.26-0.79; low-quality evidence) which increased after sensitivity analysis (RR 0.33, 95% CI 0.15-0.72; moderate-quality evidence). Application of silver dressing to the closed wound resulted in a decrease of SSI (RR 0.55, 95% CI 0.35-0.85; moderate-quality evidence). The one study of topical vitamin E oil applied to the open wound showed a significant risk reduction (RR 0.22, 95% CI 0.05-0.98; low-quality evidence).
CONCLUSIONS
Each of these interventions appears to be effective in decreasing SSI, but the number of studies for each is small and the quality of evidence is very low to moderate. Within the various outcomes of GRADE assessment, even a moderate classification suggests that further studies may well have very different results.. No randomized trials exist of combinations of two or more of the above interventions to see if there is a combined effect. Future studies should make sure that the antibiotic used preoperatively is uniform within a study and is consistent with the current guidelines. Deviation from this leads to a significant heterogeneity and risk of bias.
Topics: Administration, Topical; Anti-Infective Agents; Anti-Infective Agents, Local; Antibiotic Prophylaxis; Colon; Digestive System Surgical Procedures; Humans; Randomized Controlled Trials as Topic; Rectum; Surgical Wound Infection; Treatment Outcome
PubMed: 30019145
DOI: 10.1007/s10151-018-1814-1 -
Brain & Spine 2021During lumbar decompressive spine surgery, the epidural space is easily accessible. This intraoperative situation allows surgeons to apply an epidural bolus of analgesia... (Review)
Review
INTRODUCTION
During lumbar decompressive spine surgery, the epidural space is easily accessible. This intraoperative situation allows surgeons to apply an epidural bolus of analgesia at the end of the surgical procedure. In literature, several papers about the methods and effectiveness of delivering local analgesia during lumbar decompressive spine surgery have been published.
RESEARCH QUESTION
This systematic review and meta-analysis aims to summaries the current literature on the effectiveness and safety of intraoperative epidural analgesia in lumbar decompressive surgery, delivered as a bolus.
MATERIAL AND METHOD
A systematic search was conducted according to the PRISMA guidelines. Inclusion criteria were randomized controlled trials or comparative cohort studies of patients aged 18 years or older who underwent decompressive lumbar spine surgery. Nonsteroidal epidural analgesia had to be administered as a bolus, intraoperatively, as an adjunct to standard analgesia therapy. Primary outcome measures were reduction in postoperative pain scores, analgesics consumption and length of hospital stay. Secondary outcomes were adverse events.
RESULTS
Eight studies evaluating the effectiveness of intraoperative epidural analgesia were included. Seven studies reported statistically significant reductions in postoperative VAS-pain scores. Six studies reported a statistically significant decrease in postoperative analgesics consumption. Four studies reported on the length of hospital stay, with no statistically significant difference between study groups.
DISCUSSION AND CONCLUSION
This systematic review and meta-analysis suggests that additional intraoperative epidural nonsteroidal analgesia, delivered as a bolus, can reduce postoperative pain and postoperative analgesics consumption in patients undergoing decompressive spinal surgery. Further well-powered research is needed to bolster the evidence.
PubMed: 36247401
DOI: 10.1016/j.bas.2021.100306 -
BMC Surgery Dec 2014Surgical bleeding can be associated with an increased risk of morbidity and mortality across all surgical areas. Thus, numerous products have been developed to achieve... (Review)
Review
BACKGROUND
Surgical bleeding can be associated with an increased risk of morbidity and mortality across all surgical areas. Thus, numerous products have been developed to achieve haemostasis. A flowable haemostatic matrix such as Floseal® can quickly and reliably stop bleeding across the full spectrum of bleeding scenarios. The aim of this study was to systematically review clinical and economic evidence regarding the use of Floseal® in surgical procedures.
METHODS
An extensive literature search was conducted in PubMed, EMBASE, and the Cochrane Library over the period spanning 2003-2013 to identify publications related to Floseal® use in all types of surgical procedures. Case reports and case series studies were excluded.
RESULTS
A total of 27 papers met the selection criteria and were analysed. In the studies, blood loss and the time to achieve haemostasis were the most reported outcomes used to assess the efficacy of Floseal®. The majority of published studies (64%) examined the use of Floseal® compared with conventional methods (such as electrocautery or suturing). The remaining 36% of the studies evaluated the use of Floseal® compared with other haemostatic agents, such as Surgicel®, Gelfoam®, and Hemostase®. FloSeal® has been demonstrated to be an efficacious method in surgical procedures to reduce the time to achieve haemostasis, the frequency of intra- and postoperative bleeding, and the length of hospital stay, among other primary outcomes, resulting in less consumption of health resources.
CONCLUSIONS
The majority of the selected studies confirmed that Floseal® showed improvements over other haemostatic agents in achieving haemostasis and reducing blood loss.
Topics: Blood Loss, Surgical; Cost Savings; Gelatin Sponge, Absorbable; Hemostasis, Surgical; Hemostatics; Humans
PubMed: 25528250
DOI: 10.1186/1471-2482-14-111 -
The Cochrane Database of Systematic... 2000Trabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intra-ocular pressure. The surgery involves creating a channel through... (Review)
Review
BACKGROUND
Trabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intra-ocular pressure. The surgery involves creating a channel through the sclera, through which intra-ocular fluid can leave the eye. If scar tissue blocks the exit of the surgically created channel intra-ocular pressure rises and the operation fails. Antimetabolites are used to inhibit wound healing to prevent the conjunctiva scarring down on to the sclera. The principal antimetabolites used are 5-Fluorouracil and Mitomycin C. Both may be applied on a sponge between the conjunctiva and sclera at the beginning of surgery. 5-Fluorouracil may also be given as one or more injections under the conjunctiva after the surgery.
OBJECTIVES
The objective of this review is to assess the effects of post-operative injections of 5-Fluorouracil in eyes of people undergoing surgery for glaucoma.
SEARCH STRATEGY
We searched the Cochrane Eyes and Vision Group specialised register, The Cochrane Controlled Trials Register (CENTRAL), MEDLINE and EMBASE. We searched the reference lists of relevant articles for additional trials, and we used the Science Citation Index to search for articles that cited the included studies. We contacted investigators and experts for details of additional relevant trials.
SELECTION CRITERIA
We included randomised trials of post-operative 5-Fluorouracil injections compared to placebo injections or no injections in trabeculectomy for glaucoma.
DATA COLLECTION AND ANALYSIS
We independently assessed trial quality and extracted data. We contacted trial investigators for missing information. Data were summarised using relative risk, Peto odds ratio and weighted mean difference as appropriate.
MAIN RESULTS
Eight trials, which randomised a total of 536 participants, are included in the review. As far as can be determined from the trial reports, the methodological quality of the trials was not high. 5-Fluorouracil when delivered by post-operative injection appears to be effective in reducing the likelihood of surgical failure of trabeculectomy both in eyes at high risk of failure and those undergoing surgery for the first time. Complications are more common after 5-Fluorouracil injections, especially early and late wound leaks and temporary damage to the ocular surface. Whilst no evidence was found of an increased risk of serious sight threatening complications, people undergoing initial trabeculectomy had a substantially increased risk of ocular hypotony. None of the trials reported on the participants' perspective of care.
REVIEWER'S CONCLUSIONS
This treatment is now rarely used on the basis of a planned series of post-operative injections.This presumably reflects an aspect of the treatment that is unacceptable to both patients and doctors. None of the trials reported on the participants' perspective of care which constitutes a serious omission for an invasive treatment such as this. Increasingly, injections are used on an ad hoc basis. The effectiveness of this strategy is the subject of a future systematic review.
Topics: Antimetabolites; Fluorouracil; Glaucoma; Humans; Trabeculectomy
PubMed: 10796751
DOI: 10.1002/14651858.CD001132