BACKGROUND: Adhesions are fibrin bands that are a common consequence of gynaecological surgery. They are caused by conditions that include pelvic inflammatory disease and endometriosis. Adhesions are associated with comorbidities, including pelvic pain, subfertility, and small bowel obstruction. Adhesions also increase the likelihood of further surgery, causing distress and unnecessary expenses. Strategies to prevent adhesion formation include the use of fluid (also called hydroflotation) and gel agents, which aim to prevent healing tissues from touching one another, or drugs, aimed to change an aspect of the healing process, to make adhesions less likely to form.
OBJECTIVES: To evaluate the effectiveness and safety of fluid and pharmacological agents on rates of pain, live births, and adhesion prevention in women undergoing gynaecological surgery.
SEARCH METHODS: We searched: the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and Epistemonikos to 22 August 2019. We also checked the reference lists of relevant papers and contacted experts in the field.
SELECTION CRITERIA: Randomised controlled trials investigating the use of fluid (including gel) and pharmacological agents to prevent adhesions after gynaecological surgery.
DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. We assessed the overall quality of the evidence using GRADE methods. Outcomes of interest were pelvic pain; live birth rates; incidence of, mean, and changes in adhesion scores at second look-laparoscopy (SLL); clinical pregnancy, miscarriage, and ectopic pregnancy rates; quality of life at SLL; and adverse events.
MAIN RESULTS: We included 32 trials (3492 women), and excluded 11. We were unable to include data from nine studies in the statistical analyses, but the findings of these studies were broadly in keeping with the findings of the meta-analyses. Hydroflotation agents versus no hydroflotation agents (10 RCTs) We are uncertain whether hydroflotation agents affected pelvic pain (odds ratio (OR) 1.05, 95% confidence interval (CI) 0.52 to 2.09; one study, 226 women; very low-quality evidence). It is unclear whether hydroflotation agents affected live birth rates (OR 0.67, 95% CI 0.29 to 1.58; two studies, 208 women; low-quality evidence) compared with no treatment. Hydroflotation agents reduced the incidence of adhesions at SLL when compared with no treatment (OR 0.34, 95% CI 0.22 to 0.55, four studies, 566 women; high-quality evidence). The evidence suggests that in women with an 84% chance of having adhesions at SLL with no treatment, using hydroflotation agents would result in 54% to 75% having adhesions. Hydroflotation agents probably made little or no difference to mean adhesion score at SLL (standardised mean difference (SMD) -0.06, 95% CI -0.20 to 0.09; four studies, 722 women; moderate-quality evidence). It is unclear whether hydroflotation agents affected clinical pregnancy rate (OR 0.64, 95% CI 0.36 to 1.14; three studies, 310 women; moderate-quality evidence) compared with no treatment. This suggests that in women with a 26% chance of clinical pregnancy with no treatment, using hydroflotation agents would result in a clinical pregnancy rate of 11% to 28%. No studies reported any adverse events attributable to the intervention. Gel agents versus no treatment (12 RCTs) No studies in this comparison reported pelvic pain or live birth rate. Gel agents reduced the incidence of adhesions at SLL compared with no treatment (OR 0.26, 95% CI 0.12 to 0.57; five studies, 147 women; high-quality evidence). This suggests that in women with an 84% chance of having adhesions at SLL with no treatment, the use of gel agents would result in 39% to 75% having adhesions. It is unclear whether gel agents affected mean adhesion scores at SLL (SMD -0.50, 95% CI -1.09 to 0.09; four studies, 159 women; moderate-quality evidence), or clinical pregnancy rate (OR 0.20, 95% CI 0.02 to 2.02; one study, 30 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Gel agents versus hydroflotation agents when used as an instillant (3 RCTs) No studies in this comparison reported pelvic pain, live birth rate or clinical pregnancy rate. Gel agents probably reduce the incidence of adhesions at SLL when compared with hydroflotation agents (OR 0.50, 95% CI 0.31 to 0.83; three studies, 538 women; moderate-quality evidence). This suggests that in women with a 46% chance of having adhesions at SLL with a hydroflotation agent, the use of gel agents would result in 21% to 41% having adhesions. We are uncertain whether gel agents improved mean adhesion scores at SLL when compared with hydroflotation agents (MD -0.79, 95% CI -0.82 to -0.76; one study, 77 women; very low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Steroids (any route) versus no steroids (4 RCTs) No studies in this comparison reported pelvic pain, incidence of adhesions at SLL or mean adhesion score at SLL. It is unclear whether steroids affected live birth rates compared with no steroids (OR 0.65, 95% CI 0.26 to 1.62; two studies, 223 women; low-quality evidence), or clinical pregnancy rates (OR 1.01, 95% CI 0.66 to 1.55; three studies, 410 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention.
AUTHORS' CONCLUSIONS: Gels and hydroflotation agents appear to be effective adhesion prevention agents for use during gynaecological surgery, but we found no evidence indicating that they improve fertility outcomes or pelvic pain, and further research is required in this area. It is also worth noting that for some comparisons, wide confidence intervals crossing the line of no effect meant that clinical harm as a result of interventions could not be excluded. Future studies should measure outcomes in a uniform manner, using the modified American Fertility Society score. Statistical findings should be reported in full. No studies reported any adverse events attributable to intervention.
BACKGROUND: Pelvic adhesions can form secondary to inflammation, endometriosis, or surgical trauma. Strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene, and fibrin or collagen sheets between pelvic structures.
OBJECTIVES: To evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth, and postoperative adhesions in women of reproductive age.
SEARCH METHODS: We searched the following databases in August 2019: the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Epistemonikos, and trial registries. We searched reference lists of relevant papers, conference proceedings, and grey literature sources. We contacted pharmaceutical companies for information and handsearched relevant journals and conference abstracts.
SELECTION CRITERIA: Randomised controlled trials (RCTs) on the use of barrier agents compared with other barrier agents, placebo, or no treatment for prevention of adhesions in women undergoing gynaecological surgery.
DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for eligibility and risk of bias and extracted data. We calculated odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) using a fixed-effect model. We assessed the overall quality of the evidence using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods.
MAIN RESULTS: We included 19 RCTs (1316 women). Seven RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (11 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (seven RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT), and mixed gynaecological surgery (one RCT). The sole indication for surgery in three of the RCTs was infertility. Thirteen RCTs reported commercial funding; the rest did not state their source of funding. No studies reported our primary outcomes of pelvic pain and live birth rate. Oxidised regenerated cellulose versus no treatment at laparoscopy or laparotomy (13 RCTs) At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose at laparoscopy reduced the incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, 3 RCTs, 360 participants; I² = 75%; very low-quality evidence) or of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, 3 RCTs, 100 participants; I² = 36%; very low-quality evidence). At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose affected the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, 1 RCT, 271 participants; very low-quality evidence). However, the incidence of re-formed adhesions may have been reduced in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, 6 RCTs, 554 participants; I² = 41%; low-quality evidence). No studies reported results on pelvic pain, live birth rate, adhesion score, or clinical pregnancy rate. Expanded polytetrafluoroethylene versus oxidised regenerated cellulose at gynaecological surgery (two RCTs) We are uncertain whether expanded polytetrafluoroethylene reduced the incidence of de novo adhesions at second-look laparoscopy (OR 0.93, 95% CI 0.26 to 3.41, 38 participants; very low-quality evidence). We are also uncertain whether expanded polytetrafluoroethylene resulted in a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants; very low-quality evidence) or a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants; very low-quality evidence) when compared with oxidised regenerated cellulose. No studies reported results regarding pelvic pain, live birth rate, or clinical pregnancy rate. Collagen membrane with polyethylene glycol and glycerol versus no treatment at gynaecological surgery (one RCT) Evidence suggests that collagen membrane with polyethylene glycol and glycerol may reduce the incidence of adhesions at second-look laparoscopy (OR 0.04, 95% CI 0.00 to 0.77, 47 participants; low-quality evidence). We are uncertain whether collagen membrane with polyethylene glycol and glycerol improved clinical pregnancy rate (OR 5.69, 95% CI 1.38 to 23.48, 39 participants; very low-quality evidence). One study reported adhesion scores but reported them as median scores rather than mean scores (median score 0.8 in the treatment group vs median score 1.2 in the control group) and therefore could not be included in the meta-analysis. The reported P value was 0.230, and no evidence suggests a difference between treatment and control groups. No studies reported results regarding pelvic pain or live birth rate. In total, 15 of the 19 RCTs included in this review reported adverse events. No events directly attributed to adhesion agents were reported.
AUTHORS' CONCLUSIONS: We found no evidence on the effects of barrier agents used during pelvic surgery on pelvic pain or live birth rate in women of reproductive age because no trial reported these outcomes. It is difficult to draw credible conclusions due to lack of evidence and the low quality of included studies. Given this caveat, low-quality evidence suggests that collagen membrane with polyethylene glycol plus glycerol may be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. Low-quality evidence also shows that oxidised regenerated cellulose may reduce the incidence of re-formation of adhesions when compared with no treatment at laparotomy. It is not possible to draw conclusions on the relative effectiveness of these interventions due to lack of evidence. No adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. Common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out.
BACKGROUND: Patients undergoing colectomy for ulcerative colitis (UC) may experience complications associated with reduced quality of life (QoL), and maybe a considerable economic burden to healthcare systems. Appreciation of these burdens is important to evaluate the cost effectiveness of newer interventions for UC vs. colectomy.
AIM: To identify data representing resource utilisation or costs of complications arising from colorectal procedures in patients with UC, and data representing patient QoL, as reported by health state utility values (HSUVs).
METHODS: Embase, MEDLINE and The Cochrane Library were searched for studies (1995-2014) reporting resource use/costs of surgical complications, and HSUVs data in adult patients with UC, undergoing colorectal procedures. Conference proceedings (January 2011-January 2014) were hand-searched.
RESULTS: Twelve studies reported resource use/costs, and three reported HSUVs data in patients with UC experiencing surgical complications. Additional mean costs of postoperative complications ranged from $18 650/patient with complications at a 6-month follow-up (46% incidence) to $34 714/patient with complications over a 5-year period (49% incidence). Pouchitis, pouch failure and small bowel obstruction carried the greatest burden. Marked reductions in HSUVs were observed for patients with UC experiencing surgical complications, vs. patients with UC in a remission state.
CONCLUSIONS: There is a paucity of well reported studies on resource use/cost, and QoL burden of surgical complications in patients with UC. However, surgical complications represent a substantial burden both in terms of cost and of quality of life, with reoperations, physician fees, additional in-patient hospital stays and infertility treatment being the main cost drivers.
Aderenze addominali sono associati ad un aumento complicanze post-operatorie, i costi e il carico di lavoro. Abbiamo effettuato una revisione sistematica con raggruppamento statistico per stimare il tasso di formazione, la distribuzione e la gravità delle aderenze post-operatorie in pazienti sottoposti a chirurgia addominale. Una ricerca della letteratura è stata effettuata per tutti gli articoli di dichiarazione riguardanti l'incidenza, la distribuzione e la gravità delle aderenze tra il gennaio 1990 e il luglio 2011. Venticinque articoli soddisfacevano i criteri di inclusione. Il tasso di formazione media pesata di aderenze dopo un intervento chirurgico addominale è stata del 54% (intervallo di confidenza del 95% [CI] 40-68%), e del 66% (95% CI 38-94%) dopo chirurgia gastrointestinale, 51% (95% CI 40-63%) dopo l'ostetrica e chirurgia ginecologica e il 22% (95% CI 7-38%) dopo chirurgia urologica. Il punteggio di gravità media complessiva era di 1,11 ± 0,98 secondo la Laparoscopia Operativa Study Group classificazione. La chirurgia laparoscopica ha ridotto il tasso di formazione di aderenze del 25% e diminuisce il punteggio di gravità adesione (laparoscopica; 0,36 ± 0,69 vs aperta; 2,14 ± 0,84) per la chirurgia gastrointestinale. I nostri risultati dimostrano che l'incidenza e la gravità delle aderenze addominali varia tra specialità e procedure chirurgiche. Una maggiore consapevolezza delle aderenze può aiutare a identificare i meccanismi di base della formazione di aderenze e di nuovi approcci terapeutici, ma anche di migliorare il processo di consenso chirurgico.
Nonostante la presenza di aderenze riconosciuta cesareo-attribuibili, il suo significato clinico è incerto. La presenza di aderenze durante un parto cesareo di ripetizione può fare l'estrazione del feto lungo e la procedura impegnativo e può aumentare il rischio di lesioni agli organi adiacenti. Due metodi per la prevenzione di adesione sono discusse, chiusura peritoneale e l'uso di barriere di adesione. Chiusura peritoneale sembra essere sicuro nel breve termine. A lungo termine, le prove contrastanti derivano dalla revisione della letteratura per i possibili benefici di riduzione di adesione. Una revisione sistematica della letteratura sull'uso delle barriere di adesione nel contesto del taglio cesareo prodotto solo pochi studi, molti dei quali mancano nella metodologia. Per ora, sembra che le prove disponibili non supporta l'uso di routine di barriere di adesione durante il parto cesareo.
BACKGROUND: adesioni intra-addominali sono comuni e sfida i pazienti, i chirurghi e gli altri operatori sanitari. Essi sono potenzialmente prevenibile e diversi agenti che agiscono come barriere tra le superfici adiacenti peritoneali sono stati valutati per la profilassi. Efficacia, giudicato da revisioni sistematiche, soltanto è stato intrapreso nella chirurgia ginecologica.
OBIETTIVI: per determinare l'efficacia e la sicurezza della profilassi adesione peritoneale sull'incidenza, la distribuzione e l'adesione legati ostruzione intestinale dopo chirurgia non-ginecologica.
STRATEGIA DI RICERCA: The Cochrane Central Register of Controlled Trials, il Gruppo Cochrane Colorectal Cancer specializzata registro, MEDLINE (1966-2008), e EMBASE (1971-2008) sono stati perquisiti.
CRITERI DI SELEZIONE: Accecato e sperimentazioni cliniche non in cieco, randomizzati e quasi randomizzati sono stati considerati.
RACCOLTA DATI E ANALISI: Due autori singolarmente condotte le ricerche e ha valutato la qualità degli studi per l'inclusione che sono stati analizzati utilizzando il software RevMan analisi 5.0.0 fornito dalla Cochrane Collaboration. La meta-analisi ha utilizzato un modello a effetti casuali.
PRINCIPALI RISULTATI: Sette studi randomizzati erano ammissibili; sei rispetto acido ialuronico / carbossimetil membrana (HA / CMC) e gel ialuronato di uno 0,5% di ferro contro i controlli.
HA / CMC ha ridotto l'incidenza di aderenze (OR 0,15 (95% CI: 0,05, 0,43), p = 0,0005), con misura ridotta (WMD -25,9% (95% CI: -40,56, -11,26), p = 0,0005) e gravità. Non c'era nessuna riduzione di ostruzione intestinale bisogno di intervento chirurgico (odds ratio: 0,84 (95% CI: 0.24, 2.7) paragonabile morbidità e mortalità.
Lo studio dello 0,5% gel di ialuronato ferrico è stato terminato anticipatamente e non sono valide conclusioni potrebbe essere fatto, ma c'era una maggiore incidenza di morbidità (OR 5,04, IC 95%: 1,1, 22,9) e ileo (OR: 9,29, IC 95%: 1,57, 54,77, p = 0,01).
Conclusioni degli autori: implicazioni per la pratica
Ci sono prove che l'uso di HA / CMC membrana riduce l'incidenza, l'entità e la gravità delle aderenze che possono, teoricamente, hanno implicazioni in re-operatorio chirurgia addominale. Non vi è evidenza che l'incidenza di occlusione intestinale o necessità di un intervento chirurgico è ridotto. HA / CMC sembra essere sicuro, ma ci può essere un rischio di perdita quando avvolto intorno ad un anastomosi. HA / CMC può essere considerato per intra-addominale, la profilassi adesione a discrezione di un chirurgo e il contesto clinico.
Implicazioni per la ricerca
Sono necessarie ulteriori ricerche per esplorare l'efficacia di altri agenti in chirurgia addominale in generale. Sinergia, utilizzando agenti che si rivolgono diversi aspetti adhesiogenesis, con efficacia esplorazione in un'ampia gamma di chirurgia di emergenza e elettiva devono essere considerati. Esiti a lungo termine delle ricorrenti ostruzione intestinale e dolore cronico, l'identificazione di gruppi ad alto rischio di pazienti con valutazione del rapporto costo-efficacia sono richiesti.
Adhesions are fibrin bands that are a common consequence of gynaecological surgery. They are caused by conditions that include pelvic inflammatory disease and endometriosis. Adhesions are associated with comorbidities, including pelvic pain, subfertility, and small bowel obstruction. Adhesions also increase the likelihood of further surgery, causing distress and unnecessary expenses. Strategies to prevent adhesion formation include the use of fluid (also called hydroflotation) and gel agents, which aim to prevent healing tissues from touching one another, or drugs, aimed to change an aspect of the healing process, to make adhesions less likely to form.
OBJECTIVES:
To evaluate the effectiveness and safety of fluid and pharmacological agents on rates of pain, live births, and adhesion prevention in women undergoing gynaecological surgery.
SEARCH METHODS:
We searched: the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and Epistemonikos to 22 August 2019. We also checked the reference lists of relevant papers and contacted experts in the field.
SELECTION CRITERIA:
Randomised controlled trials investigating the use of fluid (including gel) and pharmacological agents to prevent adhesions after gynaecological surgery.
DATA COLLECTION AND ANALYSIS:
We used standard methodological procedures recommended by Cochrane. We assessed the overall quality of the evidence using GRADE methods. Outcomes of interest were pelvic pain; live birth rates; incidence of, mean, and changes in adhesion scores at second look-laparoscopy (SLL); clinical pregnancy, miscarriage, and ectopic pregnancy rates; quality of life at SLL; and adverse events.
MAIN RESULTS:
We included 32 trials (3492 women), and excluded 11. We were unable to include data from nine studies in the statistical analyses, but the findings of these studies were broadly in keeping with the findings of the meta-analyses. Hydroflotation agents versus no hydroflotation agents (10 RCTs) We are uncertain whether hydroflotation agents affected pelvic pain (odds ratio (OR) 1.05, 95% confidence interval (CI) 0.52 to 2.09; one study, 226 women; very low-quality evidence). It is unclear whether hydroflotation agents affected live birth rates (OR 0.67, 95% CI 0.29 to 1.58; two studies, 208 women; low-quality evidence) compared with no treatment. Hydroflotation agents reduced the incidence of adhesions at SLL when compared with no treatment (OR 0.34, 95% CI 0.22 to 0.55, four studies, 566 women; high-quality evidence). The evidence suggests that in women with an 84% chance of having adhesions at SLL with no treatment, using hydroflotation agents would result in 54% to 75% having adhesions. Hydroflotation agents probably made little or no difference to mean adhesion score at SLL (standardised mean difference (SMD) -0.06, 95% CI -0.20 to 0.09; four studies, 722 women; moderate-quality evidence). It is unclear whether hydroflotation agents affected clinical pregnancy rate (OR 0.64, 95% CI 0.36 to 1.14; three studies, 310 women; moderate-quality evidence) compared with no treatment. This suggests that in women with a 26% chance of clinical pregnancy with no treatment, using hydroflotation agents would result in a clinical pregnancy rate of 11% to 28%. No studies reported any adverse events attributable to the intervention. Gel agents versus no treatment (12 RCTs) No studies in this comparison reported pelvic pain or live birth rate. Gel agents reduced the incidence of adhesions at SLL compared with no treatment (OR 0.26, 95% CI 0.12 to 0.57; five studies, 147 women; high-quality evidence). This suggests that in women with an 84% chance of having adhesions at SLL with no treatment, the use of gel agents would result in 39% to 75% having adhesions. It is unclear whether gel agents affected mean adhesion scores at SLL (SMD -0.50, 95% CI -1.09 to 0.09; four studies, 159 women; moderate-quality evidence), or clinical pregnancy rate (OR 0.20, 95% CI 0.02 to 2.02; one study, 30 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Gel agents versus hydroflotation agents when used as an instillant (3 RCTs) No studies in this comparison reported pelvic pain, live birth rate or clinical pregnancy rate. Gel agents probably reduce the incidence of adhesions at SLL when compared with hydroflotation agents (OR 0.50, 95% CI 0.31 to 0.83; three studies, 538 women; moderate-quality evidence). This suggests that in women with a 46% chance of having adhesions at SLL with a hydroflotation agent, the use of gel agents would result in 21% to 41% having adhesions. We are uncertain whether gel agents improved mean adhesion scores at SLL when compared with hydroflotation agents (MD -0.79, 95% CI -0.82 to -0.76; one study, 77 women; very low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Steroids (any route) versus no steroids (4 RCTs) No studies in this comparison reported pelvic pain, incidence of adhesions at SLL or mean adhesion score at SLL. It is unclear whether steroids affected live birth rates compared with no steroids (OR 0.65, 95% CI 0.26 to 1.62; two studies, 223 women; low-quality evidence), or clinical pregnancy rates (OR 1.01, 95% CI 0.66 to 1.55; three studies, 410 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention.
AUTHORS' CONCLUSIONS:
Gels and hydroflotation agents appear to be effective adhesion prevention agents for use during gynaecological surgery, but we found no evidence indicating that they improve fertility outcomes or pelvic pain, and further research is required in this area. It is also worth noting that for some comparisons, wide confidence intervals crossing the line of no effect meant that clinical harm as a result of interventions could not be excluded. Future studies should measure outcomes in a uniform manner, using the modified American Fertility Society score. Statistical findings should be reported in full. No studies reported any adverse events attributable to intervention.
