-
Langenbeck's Archives of Surgery Jul 2023Incisional hernia (IH) is the main complication after laparotomy. In an attempt to reduce this complication, mesh techniques and studies in which the closure technique... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Incisional hernia (IH) is the main complication after laparotomy. In an attempt to reduce this complication, mesh techniques and studies in which the closure technique is modified have been proposed. Both types are characterized by comparison with the closure described as standard or conventional: 1 × 1, mass, and continuous closure. For this study, modified closure techniques (MCTs) were considered as those techniques in which an extra suture is placed (reinforced tension line (RTL), retention), the closure point is modified in distance (small bites) or shape (CLDC, Smead Jones, interrupted, Cardiff point) and which aim to reduce these complications. The objective of this network meta-analysis (NMA) was to evaluate the effectiveness of MCTs for reducing the incidence of IH and abdominal wound dehiscence (AWD) to provide objective support for their recommendation.
METHODS
An NMA was performed according to the PRISMA-NMA guidelines. The primary objective was to determine the incidence of IH and AWD, and the secondary objective was to determine the incidence of postoperative complications. Only published clinical trials were included. The risk of bias was analyzed, and the random-effects model was used to determine statistical significance.
RESULTS
Twelve studies comparing 3540 patients were included. The incidence of HI was lower in RTL, retention suture, and small bites, these techniques showed statistical differences with pooled ORs (95% CI) of 0.28 (0.09-0.83), 0.28 (0.13-0.62), and 0.44 (0.31-0.62), respectively. Associated complications, including hematoma, seroma, and postoperative pain, could not be analyzed; however, MCTs did not increase the risk of surgical site infection.
CONCLUSION
Small bites, RTL, and retention sutures decreased the prevalence of IH. RTL and retention suture decreased the prevalence of AWD. RTL was the best technique as it reduced both complications (IH and AWD) and had the best SUCRA and P-scores, and the number needed to treat (NNT) for net effect was 3.
REGISTRATION
This study was prospectively registered in the PROSPERO database under registration number CRD42021231107.
Topics: Humans; Incisional Hernia; Laparotomy; Network Meta-Analysis; Suture Techniques; Abdomen; Abdominal Injuries; Sutures; Abdominal Wound Closure Techniques; Surgical Wound Dehiscence
PubMed: 37418033
DOI: 10.1007/s00423-023-02954-w -
Journal of Cranio-maxillo-facial... Apr 2024Wound dehiscence is a common complication after secondary alveolar bone grafting (SABG), leading to unfavourable surgical outcomes. Studies have shown that autologous... (Review)
Review
Does the adjunctive use of autologous platelet concentrate during secondary alveolar bone grafting reduce the risk of wound dehiscence? A systematic review and meta-analysis.
Wound dehiscence is a common complication after secondary alveolar bone grafting (SABG), leading to unfavourable surgical outcomes. Studies have shown that autologous platelet concentrates (APC) may enhance wound healing and improve outcomes. Therefore, this review aimed to evaluate in patients with alveolar clefts, whether using APC and iliac crest bone graft can mitigate the likelihood of wound dehiscence formation compared with those who underwent iliac bone grafting only following SABG. A comprehensive literature search was conducted using various electronic databases, including PubMed, Embase, Scopus, Web of Science, EBSCOhost, Ovid MEDLINE, LILACS, Cochrane Library, and grey literature, to include studies until July 31, 2023, without any restriction to language and time of publication. Only randomized (RCT) and controlled (CCT) clinical trials were included. Two independent reviewers screened the studies based on the predefined criteria, after which a qualitative and quantitative analysis was conducted. The search yielded 821 studies, of which seven were deemed eligible for systematic review. The risk of bias assessment done using "The Cochrane collaboration tool for risk of bias assessment" for six RCTs and the "Risk of Bias in Non-randomized Studies - of Interventions" for one CCT revealed a moderate to high risk of bias. The meta-analysis of five studies showed that the overall risk of developing wound dehiscence was lower in the APC group (RR = 0.33; 95% CI: 0.16, 0.71; p = 0.005; χ = 0.82; I = 0%). Subgroup analyses based on study design further supported these findings. Although the adjuvant use of APC for alveolar cleft reconstruction reduces the risk of wound dehiscence, more studies with increased scientific rigour and fewer confounding variables are warranted.
PubMed: 38729847
DOI: 10.1016/j.jcms.2024.04.016 -
The Cochrane Database of Systematic... Feb 2024Morton's neuroma (MN) is a painful neuropathy resulting from a benign enlargement of the common plantar digital nerve that occurs commonly in the third webspace and,... (Review)
Review
BACKGROUND
Morton's neuroma (MN) is a painful neuropathy resulting from a benign enlargement of the common plantar digital nerve that occurs commonly in the third webspace and, less often, in the second webspace of the foot. Symptoms include burning or shooting pain in the webspace that extends to the toes, or the sensation of walking on a pebble. These impact on weight-bearing activities and quality of life.
OBJECTIVES
To assess the benefits and harms of interventions for MN.
SEARCH METHODS
On 11 July 2022, we searched CENTRAL, CINAHL Plus EBSCOhost, ClinicalTrials.gov, Cochrane Neuromuscular Specialised Register, Embase Ovid, MEDLINE Ovid, and WHO ICTRP. We checked the bibliographies of identified randomised trials and systematic reviews and contacted trial authors as needed.
SELECTION CRITERIA
We included all randomised, parallel-group trials (RCTs) of any intervention compared with placebo, control, or another intervention for MN. We included trials where allocation occurred at the level of the individual or the foot (clustered data). We included trials that confirmed MN through symptoms, a clinical test, and an ultrasound scan (USS) or magnetic resonance imaging (MRI).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. We assessed bias using Cochrane's risk of bias 2 tool (RoB 2) and assessed the certainty of the evidence using the GRADE framework.
MAIN RESULTS
We included six RCTs involving 373 participants with MN. We judged risk of bias as having 'some concerns' across most outcomes. No studies had a low risk of bias across all domains. Post-intervention time points reported were: three months to less than 12 months from baseline (nonsurgical outcomes), and 12 months or longer from baseline (surgical outcomes). The primary outcome was pain, and secondary outcomes were function, satisfaction or health-related quality of life (HRQoL), and adverse events (AE). Nonsurgical treatments Corticosteroid and local anaesthetic injection (CS+LA) versus local anaesthetic injection (LA) Two RCTs compared CS+LA versus LA. At three to six months: • CS+LA may result in little to no difference in pain (mean difference (MD) -6.31 mm, 95% confidence interval (CI) -14.23 to 1.61; P = 0.12, I = 0%; 2 studies, 157 participants; low-certainty evidence). (Assessed via a pain visual analogue scale (VAS; 0 to 100 mm); a lower score indicated less pain.) • CS+LA may result in little to no difference in function when compared with LA (standardised mean difference (SMD) -0.30, 95% CI -0.61 to 0.02; P = 0.06, I = 0%; 2 studies, 157 participants; low-certainty evidence). (Function was measured using: the American Orthopaedic Foot and Ankle Society Lesser Toe Metatarsophalangeal-lnterphalangeal Scale (AOFAS; 0 to 100 points) - we transformed the scale so that a lower score indicated improved function - and the Manchester Foot Pain and Disability Schedule (MFPDS; 0 to 100 points), where a lower score indicated improved function.) • CS+LA probably results in little to no difference in HRQoL when compared to LA (MD 0.07, 95% CI -0.03 to 0.17; P = 0.19; 1 study, 122 participants; moderate-certainty evidence), and CS+LA may not increase satisfaction (risk ratio (RR) 1.08, 95% CI 0.63 to 1.85; P = 0.78; 1 study, 35 participants; low-certainty evidence). (Assessed using the EuroQol five dimension instrument (EQ-5D; 0-1 point); a higher score indicated improved HRQoL.) • The evidence is very uncertain about the effects of CS+LA on AE when compared with LA (RR 9.84, 95% CI 1.28 to 75.56; P = 0.03, I = 0%; 2 studies, 157 participants; very low-certainty evidence). Adverse events for CS+LA included mild skin atrophy (3.9%), hypopigmentation of the skin (3.9%) and plantar fat pad atrophy (2.6%); no adverse events were observed with LA. Ultrasound-guided (UG) CS+LA versus non-ultrasound-guided (NUG) CS+LA Two RCTs compared UG CS+LA versus NUG CS+LA. At six months: • UG CS+LA probably reduces pain when compared with NUG CS+LA (MD -15.01 mm, 95% CI -27.88 to -2.14; P = 0.02, I = 0%; 2 studies, 116 feet; moderate-certainty evidence). (Assessed with a pain VAS.) • UG CS+LA probably increases function when compared with NUG CS+LA (SMD -0.47, 95% CI -0.84 to -0.10; P = 0.01, I = 0%; 2 studies, 116 feet; moderate-certainty evidence). We do not know of any established minimum clinical important difference (MCID) for the scales that assessed function, specifically, the MFPDS and the Manchester-Oxford Foot Questionnaire (MOXFQ; 0 to 100 points; a lower score indicated improved function.) • UG CS+LA may increase satisfaction compared with NUG CS+LA (risk ratio (RR) 1.71, 95% CI 1.19 to 2.44; P = 0.003, I = 15%; 2 studies, 114 feet; low-certainty evidence). • HRQoL was not measured. • UG CS+LA may result in little to no difference in AE when compared with NUG CS+LA (RR 0.42, 95% CI 0.12 to 1.39; P = 0.15, I = 0%; 2 studies, 116 feet; low-certainty evidence). AE included depigmentation or fat atrophy for UG CS+LA (4.9%) and NUG CS+LA (12.7%). Surgical treatments Plantar incision neurectomy (PN) versus dorsal incision neurectomy (DN) One study compared PN versus DN. At 34 months (mean; range 28 to 42 months), PN may result in little to no difference for satisfaction (RR 1.06, 95% CI 0.87 to 1.28; P = 0.58; 1 study, 73 participants; low-certainty evidence), or for AE (RR 0.95, 95% CI 0.32 to 2.85; P = 0.93; 1 study, 75 participants; low-certainty evidence) compared with DN. AE for PN included hypertrophic scaring (11.4%), foreign body reaction (2.9%); AE for DN included missed nerve (2.5%), artery resected (2.5%), wound infection (2.5%), postoperative dehiscence (2.5%), deep vein thrombosis (2.5%) and reoperation with plantar incision due to intolerable pain (5%). The data reported for pain and function were not suitable for analysis. HRQoL was not measured.
AUTHORS' CONCLUSIONS
Although there are many interventions for MN, few have been assessed in RCTs. There is low-certainty evidence that CS+LA may result in little to no difference in pain or function, and moderate-certainty evidence that UG CS+LA probably reduces pain and increases function for people with MN. Future trials should improve methodology to increase certainty of the evidence, and use optimal sample sizes to decrease imprecision.
Topics: Humans; Morton Neuroma; Anesthetics, Local; Quality of Life; Pain; Atrophy
PubMed: 38334217
DOI: 10.1002/14651858.CD014687.pub2 -
BJS Open Jul 2023Incisional hernia is a common short- and long-term complication of laparotomy and can lead to significant morbidity. The aim of this systematic review and meta-analysis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Incisional hernia is a common short- and long-term complication of laparotomy and can lead to significant morbidity. The aim of this systematic review and meta-analysis is to provide an up-to-date overview of the laparotomy closure method in elective and emergency settings with the prophylactic mesh augmentation technique.
METHODS
The Scopus, PubMed, and Web of Science databases were screened without time restrictions up to 21 June 2022 using the keywords 'laparotomy closure', 'mesh', 'mesh positioning', and 'prophylactic mesh', and including medical subject headings terms. Only RCTs reporting the incidence of incisional hernia and other wound complications after elective or emergency midline laparotomy, where patients were treated with prophylactic mesh augmentation or without mesh positioning, were included. The primary endpoint was to explore the risk of incisional hernia at different follow-up time points. The secondary endpoint was the risk of wound complications. The risk of bias for individual studies was assessed according to the Revised Cochrane risk-of-bias tools for randomized trials.
RESULTS
Eighteen RCTs, including 2659 patients, were retrieved. A reduction in the risk of incisional hernia at every time point was highlighted in the prophylactic mesh augmentation group (1 year, risk ratio 0.31, P = 0.0011; 2 years, risk ratio 0.44, P < 0.0001; 3 years, risk ratio 0.38, P = 0.0026; 4 years, risk ratio 0.38, P = 0.0257). An increased risk of wound complications was highlighted for patients undergoing mesh augmentation, although this was not significant.
CONCLUSIONS
Midline laparotomy closure with prophylactic mesh augmentation can be considered safe and effective in reducing the incidence of incisional hernia. Further trials are needed to identify the ideal type of mesh and technique for mesh positioning, but surgeons should consider prophylactic mesh augmentation to decrease incisional hernia rate, especially in high-risk patients for fascial dehiscence and even in emergency settings.
PROSPERO REGISTRATION ID
CRD42022336242 (https://www.crd.york.ac.uk/prospero/record_email.php).
Topics: Humans; Incisional Hernia; Laparotomy; Surgical Mesh; Incidence; Abdominal Wound Closure Techniques
PubMed: 37504969
DOI: 10.1093/bjsopen/zrad060 -
Journal of Wound Care Aug 2023Surgical wound dehiscence (SWD) is a serious complication-with a 40% estimated mortality rate-that occurs after surgical intervention. Since the implementation of... (Meta-Analysis)
Meta-Analysis
Surgical wound dehiscence (SWD) is a serious complication-with a 40% estimated mortality rate-that occurs after surgical intervention. Since the implementation of advanced recovery protocols, the current global incidence of SWD is unknown. This systematic review and meta-analysis estimated the worldwide incidence of SWD and explored its associated factors in general surgical patients. Eligible full-text cross-sectional, cohort and observational studies in English, between 1 January 2010 to 23 April 2021, were retrieved from MEDLINE, CINAHL, EMBASE and the Cochrane Library. Data extraction and quality appraisal were undertaken independently by three reviewers. Random effects meta-analytic models were used in the presence of substantial inconsistency. Subgroup, meta-regression and sensitivity analyses were used to explore inconsistency. Publication bias was assessed using Hunter's plots and Egger's regression test. Of 2862 publications retrieved, 27 studies were included in the final analyses. Pooled data from 741,118 patients across 24 studies were meta-analysed. The 30-day cumulative incidence of SWD was 1% (95% Confidence Interval (CI): 1-1%). SWD incidence was highest in hepatobiliary surgery, at 3% (95% CI: 0-8%). Multivariable meta-regression showed SWD was significantly associated with duration of operation and reoperation (F=7.93 (2-10); p=0.009), explaining 58.2% of the variance. Most studies were retrospective, predated the agreed global definition for SWD and measured as a secondary outcome; thus, our results likely underestimate the scope of the problem. Wider uptake of the global definition will inform the SWD surveillance and improve the accuracy of reporting.
Topics: Humans; Laparotomy; Incidence; Cross-Sectional Studies; Retrospective Studies; Postoperative Complications; Surgical Wound Dehiscence; Laparoscopy
PubMed: 37591664
DOI: 10.12968/jowc.2023.32.Sup8a.S31 -
Surgery Nov 2023Despite guideline recommendations, routine application of topical antibiotic agents to sternal edges after cardiac surgery is seldom done. Recent randomized controlled... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Despite guideline recommendations, routine application of topical antibiotic agents to sternal edges after cardiac surgery is seldom done. Recent randomized controlled trials have also questioned the effectiveness of topical vancomycin in sternal wound infection prophylaxis.
METHODS
We screened multiple databases for observational studies and randomized controlled trials assessing the effectiveness of topical vancomycin. Random effects meta-analysis and risk-profile regression were performed, and randomized controlled trials and observational studies were analyzed separately. The primary endpoint was sternal wound infection; other wound complications were also analyzed. Risk ratios served as primary statistics.
RESULTS
Twenty studies (N = 40,871) were included, of which 7 were randomized controlled trials (N = 2,187). The risk of sternal wound infection was significantly reduced by almost 70% in the topical vancomycin group (risk ratios [95% confidence intervals]: 0.31 (0.23-0.43); P < .00001) and was comparable between randomized controlled trials (0.37 [0.21-0.64]; P < .0001) and observational studies (0.30 [0.20-0.45]; P < .00001; P = .57). Topical vancomycin significantly reduced the risk of superficial sternal wound infections (0.29 [0.15-0.53]; P < .00001) and deep sternal wound infections (0.29 [0.19-0.44]; P < .00001). A reduction in the risk of mediastinitis and sternal dehiscence risks was also demonstrated. Risk profile meta-regression showed a significant relationship between a higher risk of sternal wound infection and a higher benefit accrued with topical vancomycin (ß-coeff. = -0.00837; P < .0001). The number needed to treat was 58.2. A significant benefit was observed in patients with diabetes mellitus (risk ratios 0.21 [0.11-0.39]; P < .00001). There was no evidence of vancomycin or methicillin resistance; on the contrary, the risk of gram-negative cultures was reduced by over 60% (risk ratios 0.38 [0.22-0.66]; P = .0006).
CONCLUSION
Topical vancomycin effectively reduces the risk of sternal wound infection in cardiac surgery patients.
Topics: Humans; Vancomycin; Surgical Wound Infection; Anti-Bacterial Agents; Cardiac Surgical Procedures; Sternum
PubMed: 37414589
DOI: 10.1016/j.surg.2023.05.031 -
Journal of Plastic, Reconstructive &... Dec 2023The barbed suture, which can eliminate knot tying and accelerate the placement of sutures, is an innovative type of suture, whereas the benefits of cosmetic surgeries... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The barbed suture, which can eliminate knot tying and accelerate the placement of sutures, is an innovative type of suture, whereas the benefits of cosmetic surgeries (CS) are controversial. This study aimed to comprehensively evaluate the effectiveness and safety of barbed sutures in CS.
METHOD
PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov were searched for English studies comparing the use of barbed with conventional sutures in CS up to October 2020. The updated Cochrane risk-of-bias tool (ROB2.0) and Newcastle-Ottawa Scale (NOS) were utilized to evaluate the risk of bias. Subgroup analysis was performed according to study designs and barbed suture types.
RESULTS
A total of 14 studies, including 5 randomized controlled trials and 9 cohort studies, were included (risk of bias: moderate to low), representing 2259 patients. The barbed suture was identified to reduce suture time (mean difference [MD]=-6.18, 95% confidence interval [CI]: -8.75 to -3.60, P < 0.00001) and operative time (MD=-10.80, 95% CI: -20.83 to -0.76, P = 0.03) without increasing the hospital stays and total postoperative complications (most were Clavien I and IIIa). No significant difference was detected for incisional infection, delayed wound healing, and hematoma; however, increasing incidence of wound dehiscence (odds ratio [OR]=1.60, 95% CI: 1.09-2.34, P = 0.02) and suture extrusion (OR=3.97, 95%CI: 1.96-8.04, P = 0.0001) were found, particularly in the unidirectional barbed suture subgroup. Barbed sutures might also help CS advance and reduce seroma formation.
CONCLUSION
The barbed suture was effective in CS; however, its safety needs to be cautiously interpreted as it might be related to more wound dehiscence and suture extrusion despite similar total postoperative complications with conventional sutures. This study might provide important references for decision-makers and clinicians, though further evidence of randomized design, larger sample size, longer follow-up, and standardized rating approaches are warranted.
Topics: Humans; Surgery, Plastic; Suture Techniques; Surgical Wound Infection; Cohort Studies; Sutures
PubMed: 37939647
DOI: 10.1016/j.bjps.2023.10.084 -
Techniques in Coloproctology Dec 2023To mitigate pelvic wound issues following perineal excision of rectal or anal cancer, a number of techniques have been suggested as an alternative to primary closure.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
To mitigate pelvic wound issues following perineal excision of rectal or anal cancer, a number of techniques have been suggested as an alternative to primary closure. These methods include the use of a biological/dual mesh, omentoplasty, muscle flap, and/or pelvic peritoneum closure. The aim of this network analysis was to compare all the available surgical techniques used in the attempt to mitigate issues associated with an empty pelvis.
METHODS
An electronic systematic search using MEDLINE databases (PubMed), EMBASE, and Web of Science was performed (Last date of research was March 15th, 2023). Studies comparing at least two of the aforementioned surgical techniques for perineal wound reconstruction during abdominoperineal resection, pelvic exenteration, or extra levator abdominoperineal excision were included. The incidence of primary healing, complication, and/or reintervention for perineal wound were evaluated. In addition, the overall incidence of perineal hernia was assessed.
RESULTS
Forty-five observational studies and five randomized controlled trials were eligible for inclusion reporting on 146,398 patients. All the surgical techniques had a comparable risk ratio (RR) in terms of primary outcomes. The pooled network analysis showed a lower RR for perineal wound infection when comparing primary closure (RR 0.53; Crl 0.33, 0.89) to muscle flap. The perineal wound dehiscence RR was lower when comparing both omentoplasty (RR 0.59; Crl 0.38, 0.95) and primary closure (RR 0.58; Crl 0.46, 0.77) to muscle flap.
CONCLUSIONS
Surgical options for perineal wound closure have evolved significantly over the last few decades. There remains no clear consensus on the "best" option, and tailoring to the individual remains a critical factor.
Topics: Humans; Network Meta-Analysis; Perineum; Plastic Surgery Procedures; Postoperative Complications; Surgical Flaps
PubMed: 37843643
DOI: 10.1007/s10151-023-02868-1 -
International Journal of Surgery... Jan 2024Metabolic syndrome (MetS) is characterised by the presence of at least three of the five following components: insulin resistance, obesity, chronic hypertension,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Metabolic syndrome (MetS) is characterised by the presence of at least three of the five following components: insulin resistance, obesity, chronic hypertension, elevated serum triglycerides, and decreased high-density lipoprotein cholesterol concentrations. It is estimated to affect 1 in 3 people around the globe and is reported to affect 46% of surgical patients. For people with MetS who undergo surgery, an emerging body of literature points to significantly poorer postoperative outcomes compared with nonaffected populations. The aim of this study is to review the current evidence on the risks of surgical complications in patients with MetS compared to those without MetS.
METHODS
Systematic review and meta-analysis using PRISMA and AMSTAR reporting guidelines.
RESULTS
The meta-analysis included 63 studies involving 1 919 347 patients with MetS and 11 248 114 patients without MetS. Compared to individuals without the condition, individuals with MetS were at an increased risk of mortality (OR 1.75 95% CI: 1.36-2.24; P <0.01); all surgical site infection types as well as dehiscence (OR 1.64 95% CI: 1.52-1.77; P <0.01); cardiovascular complications (OR 1.56 95% CI: 1.41-1.73; P <0.01) including myocardial infarction, stroke, cardiac arrest, cardiac arrythmias and deep vein thrombosis; increased length of hospital stay (MD 0.65 95% CI: 0.39-0.9; P <0.01); and hospital readmission (OR 1.55 95% CI: 1.41-1.71; P <0.01).
CONCLUSION
MetS is associated with a significantly increased risk of surgical complications including mortality, surgical site infection, cardiovascular complications, increased length of stay, and hospital readmission. Despite these risks and the high prevalence of MetS in surgical populations there is a lack of evidence on interventions for reducing surgical complications in patients with MetS. The authors suggest prioritising interventions across the surgical continuum that include (1) preoperative screening for MetS; (2) surgical prehabilitation; (3) intraoperative monitoring and management; and (4) postoperative rehabilitation and follow-up.
Topics: Humans; Metabolic Syndrome; Obesity; Surgical Wound Infection; Insulin Resistance; Myocardial Infarction; Risk Factors
PubMed: 37916943
DOI: 10.1097/JS9.0000000000000834 -
The Cochrane Database of Systematic... Aug 2023This is the third update of the original Cochrane Review published in July 2005 and updated previously in 2012 and 2016. Cancer is a significant global health issue.... (Review)
Review
BACKGROUND
This is the third update of the original Cochrane Review published in July 2005 and updated previously in 2012 and 2016. Cancer is a significant global health issue. Radiotherapy is a treatment modality for many malignancies, and about 50% of people having radiotherapy will be long-term survivors. Some will experience late radiation tissue injury (LRTI), developing months or years following radiotherapy. Hyperbaric oxygen therapy (HBOT) has been suggested as a treatment for LRTI based on the ability to improve the blood supply to these tissues. It is postulated that HBOT may result in both healing of tissues and the prevention of complications following surgery and radiotherapy.
OBJECTIVES
To evaluate the benefits and harms of hyperbaric oxygen therapy (HBOT) for treating or preventing late radiation tissue injury (LRTI) compared to regimens that excluded HBOT.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was 24 January 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing the effect of HBOT versus no HBOT on LRTI prevention or healing.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were 1. survival from time of randomisation to death from any cause; 2. complete or substantial resolution of clinical problem; 3. site-specific outcomes; and 4.
ADVERSE EVENTS
Our secondary outcomes were 5. resolution of pain; 6. improvement in quality of life, function, or both; and 7. site-specific outcomes. We used GRADE to assess certainty of evidence.
MAIN RESULTS
Eighteen studies contributed to this review (1071 participants) with publications ranging from 1985 to 2022. We added four new studies to this updated review and evidence for the treatment of radiation proctitis, radiation cystitis, and the prevention and treatment of osteoradionecrosis (ORN). HBOT may not prevent death at one year (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.47 to 1.83; I = 0%; 3 RCTs, 166 participants; low-certainty evidence). There is some evidence that HBOT may result in complete resolution or provide significant improvement of LRTI (RR 1.39, 95% CI 1.02 to 1.89; I = 64%; 5 RCTs, 468 participants; low-certainty evidence) and HBOT may result in a large reduction in wound dehiscence following head and neck soft tissue surgery (RR 0.24, 95% CI 0.06 to 0.94; I = 70%; 2 RCTs, 264 participants; low-certainty evidence). In addition, pain scores in ORN improve slightly after HBOT at 12 months (mean difference (MD) -10.72, 95% CI -18.97 to -2.47; I = 40%; 2 RCTs, 157 participants; moderate-certainty evidence). Regarding adverse events, HBOT results in a higher risk of a reduction in visual acuity (RR 4.03, 95% CI 1.65 to 9.84; 5 RCTs, 438 participants; high-certainty evidence). There was a risk of ear barotrauma in people receiving HBOT when no sham pressurisation was used for the control group (RR 9.08, 95% CI 2.21 to 37.26; I = 0%; 4 RCTs, 357 participants; high-certainty evidence), but no such increase when a sham pressurisation was employed (RR 1.07, 95% CI 0.52 to 2.21; I = 74%; 2 RCTs, 158 participants; high-certainty evidence).
AUTHORS' CONCLUSIONS
These small studies suggest that for people with LRTI affecting tissues of the head, neck, bladder and rectum, HBOT may be associated with improved outcomes (low- to moderate-certainty evidence). HBOT may also result in a reduced risk of wound dehiscence and a modest reduction in pain following head and neck irradiation. However, HBOT is unlikely to influence the risk of death in the short term. HBOT also carries a risk of adverse events, including an increased risk of a reduction in visual acuity (usually temporary) and of ear barotrauma on compression. Hence, the application of HBOT to selected participants may be justified. The small number of studies and participants, and the methodological and reporting inadequacies of some of the primary studies included in this review demand a cautious interpretation. More information is required on the subset of disease severity and tissue type affected that is most likely to benefit from this therapy, the time for which we can expect any benefits to persist and the most appropriate oxygen dose. Further research is required to establish the optimum participant selection and timing of any therapy. An economic evaluation should also be undertaken.
Topics: Humans; Hyperbaric Oxygenation; Radiation Injuries; Neoplasms; Osteoradionecrosis; Disease Progression; Pain; Barotrauma
PubMed: 37585677
DOI: 10.1002/14651858.CD005005.pub5