Adhesion-related readmissions after open and laparoscopic surgery: a retrospective cohort study (SCAR update).

BACKGROUND: Adhesions are the most common driver of long-term morbidity after abdominal surgery. Although laparoscopy can reduce adhesion formation, the effect of minimally invasive surgery on long-term adhesion-related morbidity remains unknown. We aimed to assess the impact of laparoscopy on adhesion-related readmissions in a population-based cohort. METHODS: We did a retrospective cohort study of patients of any age who had abdominal or pelvic surgery done using laparoscopic or open approaches between June 1, 2009, and June 30, 2011, using validated population data from the Scottish National Health Service. All patients who had surgery were followed up until Dec 31, 2017. The primary outcome measure was the incidence of hospital readmissions directly related to adhesions in the laparoscopic and open surgery cohorts at 5 years. Readmissions were categorised as directly related to adhesions, possibly related to adhesions, and readmissions for an operation that was potentially complicated by adhesions. We did subgroup analyses of readmissions by anatomical site of surgery and used Kaplan-Meier analyses to assess differences in survival across subgroups. We used multivariable Cox-regression analysis to determine whether surgical approach was an independent and significant risk factor for adhesion-related readmissions. FINDINGS: Between June 1, 2009, and June 30, 2011, 72 270 patients had an index abdominal or pelvic surgery, of whom 21 519 (29·8%) had laparoscopic index surgery and 50 751 (70·2%) had open surgery. Of the 72 270 patients who had surgery, 2527 patients (3·5%) were readmitted within 5 years of surgery for disorders directly related to adhesions, 12 687 (17·6%) for disorders possibly related to adhesions, and 9436 (13·1%) for operations potentially complicated by adhesions. Of the 21 519 patients who had laparoscopic surgery, 359 (1·7% [95% CI 1·5-1·9]) were readmitted for disorders directly related to adhesions compared with 2168 (4·3% [4·1-4·5]) of 50 751 patients in the open surgery cohort (p<0·0001). 3443 (16·0% [15·6-16·4]) of 21 519 patients in the laparoscopic surgery cohort were readmitted for disorders possibly related to adhesions compared with 9244 (18·2% [17·8-18·6]) of 50 751 patients in the open surgery cohort (p<0·005). In multivariate analyses, laparoscopy reduced the risk of directly related readmissions by 32% (hazard ratio [HR] 0·68, 95% CI 0·60-0·77), and of possibly related readmissions by 11% (HR 0·89, 0·85-0·94) compared with open surgery. Procedure type, malignancy, sex, and age were also independently associated with risk of adhesion-related readmissions. INTERPRETATION: Laparoscopic surgery reduces the incidence of adhesion-related readmissions. However, the overall burden of readmissions associated with adhesions remains high. With further increases in the use of laparoscopic surgery expected in the future, the effect at the population level might become larger. Further steps remain necessary to reduce the incidence of adhesion-related postsurgical complications. FUNDING: Dutch Adhesion Group and Nordic Pharma.

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol.

BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015.

Epidemiology and Prevention of Postsurgical Adhesions Revisited.

OBJECTIVE: To provide a comprehensive review of recent epidemiologic data on the burden of adhesion-related complications and adhesion prevention. Second, we elaborate on economic considerations for the application of antiadhesion barriers. BACKGROUND: Because the landmark SCAR studies elucidated the impact of adhesions on readmissions for long-term complications of abdominal surgery, adhesions are widely recognized as one of the most common causes for complications after abdominal surgery. Concurrently, interest in adhesion prevention revived and several new antiadhesion barriers were developed. Although these barriers have now been around for more than a decade, adhesion prevention is still seldom applied. METHODS: The first part of this article is a narrative review evaluating the results of recent epidemiological studies on adhesion-related complications and adhesion prevention. In part II, these epidemiological data are translated into a cost model of adhesion-related complications and the potential cost-effectiveness of antiadhesion barriers is explored. RESULTS: New epidemiologic data warrant a shift in our understanding of the socioeconomic burden of adhesion-related complications and the indications for adhesion prevention strategies. Increasing evidence from cohort studies and systematic reviews shows that difficulties during reoperations, rather than small bowel obstructions, account for the majority of adhesion-related morbidity. Laparoscopy and antiadhesion barriers have proven to reduce adhesion formation and related morbidity. The direct health care costs associated with treatment of adhesion-related complications within the first 5 years after surgery are $2350 following open surgery and $970 after laparoscopy. Costs are about 50% higher in fertile-age female patients. Application of an antiadhesion barriers could save between $328 and $680 after open surgery. After laparoscopy, the costs impact ranges from $82 in expenses to $63 of savings. CONCLUSIONS: Adhesions are an important cause for long-term complications in both open and laparoscopic surgery. Adhesiolysis during reoperations seems to impact adhesion-related morbidity most. Routine application of antiadhesion barriers in open surgery is safe and cost-effective. Application of antiadhesion barriers can be cost-effective in selected cases of laparoscopy. More research is needed to develop barriers suitable for laparoscopic use.

Gas embolism during hysteroscopic surgery using bipolar or monopolar diathermia: a randomized controlled trial.

OBJECTIVE: The objective of the study was to determine the incidence and amount of gas embolism during hysteroscopic surgery using either monopolar or bipolar diathermia and to investigate the relationship between the severity of gas embolism and the amount of intravasation of distension fluid. STUDY DESIGN: This was a randomized, observer-blinded trial. Fifty patients, scheduled for hysteroscopic surgery, were assigned to either monopolar or bipolar diathermia. Transesophageal echocardiography was used to detect and classify gas embolism (grade 0-IV). Intravasation of distension fluid was measured. RESULTS: Venous gas embolism was observed in all but 1 patient. A higher incidence of more extensive (grade IV) was seen during bipolar diathermia (42% vs 13%; P = .031). Paradoxical embolism was observed in 2 patients. When intravasation exceeded 1000 mL, significantly more grade IV venous gas embolism was seen (P = .049). CONCLUSION: During hysteroscopic surgery, gas embolism was equally observed irrespective of the type of diathermia. However, more extensive embolism was observed when intravasation of distension fluid exceeded 1 L. These results question the acceptance of up to 2500 mL intravasation of distension fluid if bipolar diathermia is used.

Adhesion awareness: a national survey of surgeons.

BACKGROUND: Postoperative adhesions are the most frequent complication of abdominal surgery, leading to high morbidity, mortality, and costs. However, the problem seems to be neglected by surgeons for largely unknown reasons. METHODS: A survey assessing knowledge and personal opinion about the extent and impact of adhesions was sent to all Dutch surgeons and surgical trainees. The informed-consent process and application of antiadhesive agents were questioned in addition. RESULTS: The response rate was 34.4%. Two thirds of all respondents (67.7%) agreed that adhesions exert a clinically relevant, negative effect. A negative perception of adhesions correlated with a positive attitude regarding adhesion prevention (ρ = 0.182, p < 0.001). However, underestimation of the extent and impact of adhesions resulted in low knowledge scores (mean test score 37.6%). Lower scores correlated with more uncertainty about indications for antiadhesive agents which, in turn, correlated with never having used any of these agents (ρ = 0.140, p = 0.002; ρ = 0.095, p = 0.035; respectively). Four in 10 respondents (40.9%) indicated that they never inform patients on adhesions and only 9.8% informed patients routinely. A majority of surgeons (55.9%) used antiadhesive agents in the past, but only a minority (13.4%) did in the previous year. Of trainees, 82.1% foresaw an increase in the use of antiadhesive agents compared to 64.5% of surgeons (p < 0.001). CONCLUSIONS: The magnitude of the problem of postoperative adhesions is underestimated and informed consent is provided inadequately by Dutch surgeons. Exerting adhesion prevention is related to the perception of and knowledge about adhesions.

Delayed versus immediate oxytocin infusion after amniotomy for induction of labour: A randomised controlled pilot trial.

OBJECTIVE: To get a preliminary understanding of the amniotomy-to-delivery interval, patients' experiences and risks by awaiting spontaneous contractions after amniotomy and to explore the need and feasibility for a larger randomised controlled trial. METHODS: We performed a randomised controlled pilot trial in a peripheral teaching hospital in Amsterdam, The Netherlands. Women with term, singleton pregnancy in vertex position undergoing labour induction for one of the five following indications: prolonged pregnancy, mild hypertensive disorders, diabetes, expected macrosomia, maternal request, were randomised to amniotomy with 12-hours delayed oxytocin (DO), or amniotomy with immediate oxytocin (IO). RESULTS: A total of 64 women was included in the analysis. The median amniotomy-to-delivery interval for the DO-group was 15 h (IQR 8-21), and 6 h (IQR 5-11) for the IO-group (HR, 0.41; 95% CI, 0.24-0.70), with equal patient reported childbirth perception in the overall group (P=0.43). Parous women reported a significantly less positive perception of labour (P=0.02) and used pain relief more often (RR, 2.93; 95% CI, 1.05-8.19) in the DO-group. The proportion of women delivered within 24 h was not significantly different between groups (RR, 0.30; 95% CI, 0.05-1.83). Other delivery and neonatal outcomes did not differ significantly between groups, possibly due to being underpowered. CONCLUSION: Preliminary results show that amniotomy-to-delivery interval was prolonged with 9 h in the DO-group, with equal patient reported childbirth perception in the overall group. Parous women have a less positive perception of their delivery and used pain relief more often when oxytocin was delayed. Delaying oxytocin infusion after amniotomy should be further investigated in an adequately powered randomised trial.

Surgical treatment of adhesion-related chronic abdominal and pelvic pain after gynaecological and general surgery: a systematic review and meta-analysis.

BACKGROUND: Chronic pain is a frequent post-operative complication, affecting ~20-40% of patients who have undergone surgery of the female genital or alimentary tract. Chronic pain is an important risk factor for diminished quality of life after surgery. Adhesions are frequently associated with chronic post-operative pain; however, surgical treatment of adhesion-related pain is controversial. OBJECTIVE AND RATIONALE: The aim of this study was to investigate the efficacy and harms of surgical interventions for chronic post-operative pain attributable to adhesions. SEARCH METHODS: A search was conducted using PubMed, EMBASE and CENTRAL, without restrictions pertaining to date, publication status or language. Randomized trials and cohort studies from all surgical interventions for chronic post-operative pain were considered eligible. Patients with a concomitant diagnosis that could cause chronic pain (e.g. endometriosis or inflammatory conditions) were excluded. Outcome measures were graded according to clinical relevance, with improvement of pain at long-term follow-up regarded as most clinically relevant. OUTCOMES: A total of 4294 unique citations were identified, of which 13 studies met the criteria for inclusion. Two of the analysed studies were randomized trials, of which one had a low risk of bias. Only one trial, randomizing between laparoscopic adhesiolysis without an adhesion barrier and diagnostic laparoscopy, reported improvement of pain at long-term follow-up. In this trial, pain improved in 55.8% of patients after adhesiolysis and in 41.7% of patients in the control group; however, the difference was not significant (relative risk (RR) 1.34; 95% CI: 0.89-2.02). Most non-randomized studies had mid-length follow-up (6-12 months). In pooled analyses of trials and non-randomized studies, improvement of pain was reported in 72% of patients who underwent adhesiolysis (95% CI: 61-83%) at any follow-up longer than 3 months. The incidence of negative laparoscopies was 20% (95% CI: 10-30%). The overall incidence of complications following laparoscopic adhesiolysis was 4% (95% CI: 1-6%). WIDER IMPLICATIONS: Laparoscopic adhesiolysis reduces pain from adhesions in ~70% of patients in the initial phase after treatment. However, there is little evidence for long-term efficacy of adhesiolysis for chronic pain. Other drawbacks of laparoscopic adhesiolysis are the high rate of negative laparoscopies and the risk of bowel injury. At present, there is little evidence to support routine use of adhesiolysis in treatment for chronic pain. New research is needed to investigate whether the results of adhesiolysis can be improved with new techniques for diagnosis and prevention of adhesion reformation.

Prevalence of intrauterine adhesions after the application of hyaluronic acid gel after dilatation and curettage in women with at least one previous curettage: short-term outcomes of a multicenter, prospective randomized controlled trial.

OBJECTIVE: To examine whether intrauterine application of auto-crosslinked hyaluronic acid (ACP) gel, after dilatation and curettage (D&C), reduces the incidence of intrauterine adhesions (IUAs). DESIGN: Multicenter; women and assessors blinded prospective randomized trial. SETTING: University and university-affiliated teaching hospitals. PATIENT(S): A total of 152 women with a miscarriage of <14 weeks with at least one previous D&C for miscarriage or termination of pregnancy. INTERVENTION(S): Women were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A follow-up diagnostic hysteroscopy was scheduled 8-12 weeks after the D&C procedure. MAIN OUTCOME MEASURE(S): The primary outcome was the number of women with IUAs and the secondary outcome was the severity of IUAs. RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The IUAs were observed in 10 (13.0%) and 22 women (30.6%), respectively (relative risk, 0.43; 95% confidence interval 0.22-0.83). Mean adhesion score and the amount of moderate-to-severe IUAs were significantly lower in the intervention group according to the American Fertility Society (AFS) and European Society of Gynecological Endoscopy classifications systems of adhesions. CONCLUSION(S): Intrauterine application of ACP gel after D&C for miscarriage in women with at least one previous D&C seems to reduce the incidence and severity of IUAs but does not eliminate the process of adhesion formation completely. Future studies are needed to confirm our findings and to evaluate the effect of ACP gel on fertility and reproductive outcomes. CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

Adhesion awareness: a nationwide survey of gynaecologists.

OBJECTIVE: Adhesions and related complications lead to substantially increased morbidity and mortality which increase medical costs. We investigated the awareness of adhesions among Dutch gynaecologists and gynaecology residents. STUDY DESIGN: A survey, assessing knowledge and opinion about adhesions, was sent to a randomly selected group of 381 gynaecologists and 256 residents. In addition, the informed consent process and application of anti-adhesive agents were questioned. RESULTS: The response rate was 56.9%. Complications due to adhesions were highly underestimated, leading to low knowledge scores (mean score 35.1%). Of all respondents 73.8% agreed that adhesions exert a clinically relevant and negative effect, but only 51.2% expressed a positive opinion on adhesion prevention. This correlated with a stronger belief in the clinically relevant and negative effects of adhesions and the opinion that adhesion prevention belongs to standard care (ρ=0.212, p<0.001; ρ=0.495, p<0.001). Of all respondents 31.4% expressed a positive attitude towards anti-adhesive agents and 19.8% expressed a negative one. A negative attitude correlated with a negative view in terms of cost-benefits (ρ=0.245, p<0.001). Although 43.5% had used anti-adhesive agents in the past year, 20.9% had used them before but stopped using agents in the past year. Only 5.2% routinely included adhesions or related morbidity in the informed consent. CONCLUSIONS: Awareness of adhesions is limited and informed consent is provided inadequately. Implementing adhesion prevention is related with awareness of adhesions. These findings underline the need to embed adhesions, related morbidity and prevention in educational programmes.

Burden of adhesions in abdominal and pelvic surgery: systematic review and met-analysis.

OBJECTIVE: To estimate the disease burden of the most important complications of postoperative abdominal adhesions: small bowel obstruction, difficulties at reoperation, infertility, and chronic pain. DESIGN: Systematic review and meta-analyses. DATA SOURCES: Searches of PubMed, Embase, and Central, from January 1990 to December 2012, without restrictions to publication status or language. STUDY SELECTION: All types of studies reporting on the incidence of adhesion related complications were considered. DATA EXTRACTION AND ANALYSIS: The primary outcome was the incidence of adhesive small bowel obstruction in patients with a history of abdominal surgery. Secondary outcomes were the incidence of small bowel obstruction by any cause, difference in operative time, enterotomy during adhesiolysis, and pregnancy rate after abdominal surgery. Subgroup and sensitivity analyses were done to study the robustness of the results. A random effects model was used to account for heterogeneity between studies. RESULTS: We identified 196 eligible papers. Heterogeneity was considerable for almost all meta-analyses. The origin of heterogeneity could not be explained by study design, study quality, publication date, anatomical site of operation, or operative technique. The incidence of small bowel obstruction by any cause after abdominal surgery was 9% (95% confidence interval 7% to 10%; I(2)=99%). the incidence of adhesive small bowel obstruction was 2% (2% to 3%; I(2)=93%); presence of adhesions was generally confirmed by emergent reoperation. In patients with a known cause of small bowel obstruction, adhesions were the single most common cause (56%, 49% to 64%; I(2)=96%). Operative time was prolonged by 15 minutes (95% confidence interval 9.3 to 21.1 minutes; I(2)=85%) in patients with previous surgery. Use of adhesiolysis resulted in a 6% (4% to 8%; I(2)=89%) incidence of iatrogenic bowel injury. The pregnancy rate after colorectal surgery in patients with inflammatory bowel disease was 50% (37% to 63%; I(2)=94%), which was significantly lower than the pregnancy rate in medically treated patients (82%, 70% to 94%; I(2)=97%). CONCLUSIONS: This review provides detailed and systematically analysed knowledge of the disease burden of adhesions. Complications of postoperative adhesion formation are frequent, have a large negative effect on patients' health, and increase workload in clinical practice. The quantitative effects should be interpreted with caution owing to large heterogeneity. REGISTRATION: The review protocol was registered through PROSPERO (CRD42012003180).

Embolism of air and gas in hysteroscopic procedures: pathophysiology and implication for daily practice.

Hysteroscopic surgery has gained in popularity and has become the method of choice for diagnostic and therapeutic interventions of intrauterine pathology. Advantages consist of short operating time, rapid postoperative recovery, and low morbidity. However, there are concerns about the potential serious complications that can occur, such as venous air and gas embolism. These are rare but hazardous complications, which can occur in all surgical procedures. In hysteroscopic surgery, large uterine veins may be exposed and are, therefore, a point of entry for gas or air. A number of fatal and nonfatal cases have been described as case reports. Although awareness for air and gas embolism is raised this way, proper guidelines as to how to reduce the risk of venous gas or air embolism are lacking. The pathophysiologic difference between gas and air embolism is described herein because composition of the gases differs as does their physiologic effects. A gas embolism is likely to be derived from electrosurgical vapors whereas air embolism seems to arise from improper purging of lines or reinsertion of hysteroscopic instruments. Treatment regimens must, therefore, be designed to address the specific gases involved. Signs and symptoms of these different embolisms are described, as early detection and intervention are crucial for survival. Furthermore, we provide guidelines for operating department personnel, surgeons, and anesthesiologists to reduce the risk of venous gas or air embolism during hysteroscopic procedures. Potential complications of these procedures may be prevented this way.

Complications of laparoscopy: an inquiry about closed- versus open-entry technique.

OBJECTIVE: The purpose of this study was to determine the amount of complications and the incidence of open- versus closed-entry (either by Veress needle or first trocar) technique in gynecologic laparoscopy in The Netherlands. STUDY DESIGN: Questionnaire analysis of members of the Dutch Society for Gynaecological Endoscopy and Minimal Invasive Surgery was combined with a Medline literature search. Data related to complications on entry from January 1,1997, through December 31, 2001, were collected by questionnaire and were separated into group I (Veress needle or first trocar) and group II (open-entry technique). The number of laparoscopy procedures, years of experience, and indications to perform the chosen entry technique were collected. RESULTS: Response rate was 98%. The procedures were performed by 187 gynecologists in 74 hospitals (72%) in The Netherlands. Groups I and II were comparable to each other, with respect to type of clinic (teaching vs nonteaching hospital), the number of procedures, and the experience of gynecologists. One hundred six gynecologists (57%) used only the closed-entry technique. This group reported 31 complications (0.1%) in 31,532 procedures. Even in the case of patients who were at risk for entry-related complications (previous laparotomy, obesity), pneumoperitoneum was established by the closed-entry technique. However, most gynecologists used an alternative insufflation point (eg, Palmer's point). The remaining 81 gynecologists used both entry techniques. However, the open-entry technique was used on special indications and in only 2.0% of cases (range: 1-20%). These special indications were suspected adhesions or previous laparotomy (90%) and obese (7%) or very thin patients (3%). These 81 gynecologists reported 20,027 closed-entry procedures and 579 open-entry procedures and complication rates of 0.12% and 1.38%, respectively (P<.001). Significantly more visceral lesions were found (P<.001) at open-entry technique in group II. Our literature search showed a calculated average entry complication rate for the closed-entry technique for visceral and vascular lesions of 0.44 of 1000 procedures and 0.31 of 1000 procedures, respectively. CONCLUSION: Although 43% of the gynecologists in this study performed the open-entry technique in laparoscopy, Dutch gynecologists seldom use this technique. When it is performed in selected patients, the number of complications is not reduced necessarily. In contrast to published data of general surgeons' findings, the number of entry-related complications in the open technique was significantly higher than the closed-entry technique. There is no evidence to abandon the closed-entry technique in laparoscopy. However, the selection of patients for an open- or alternative-entry procedure is still recommended.