Quality of life and chronic pain four years after gastrointestinal surgery

PURPOSE: Little is known about the prevalence of chronic postsurgical pain after gastrointestinal surgery. This study was designed to assess the prevalence of chronic pain and quality of life in a cohort of patients who underwent surgery for benign and malignant gastrointestinal disease. METHODS: A prospective cohort design was used to assess quality of life and morbidity at four years postoperatively in 435 patients who had upper, hepatopancreaticobiliary, small-bowel, and/or colorectal anastomotic surgery in 1999 at one regional center in Northeast Scotland. Chronic pain and quality of life were assessed by postal survey using the European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaire and McGill Pain Questionnaire. RESULTS: Of the 435 patients recruited in 1999, 135 (31 percent) had died by censor date in 2003. There was a 74 percent (n = 202) response rate from surviving patients eligible for follow-up. Prevalence of chronic pain at four years postoperatively was 18 percent (95 percent confidence interval, 13-23 percent). Pain was predominantly neuropathic in character; a subgroup reported moderate-to-severe pain. Risk factors for chronic postsurgical pain included female gender, younger age, and surgery for benign disease. Compared with those who were pain-free at follow-up, patients with chronic pain had poorer functioning, poorer global quality of life, and more severe symptoms, independent of age, gender, and cancer status. CONCLUSIONS: The prevalence of chronic pain after laparotomy for gastrointestinal malignancy and nonmalignant conditions at four years after surgery was 18 percent. These patients had significantly poorer quality of life scores independent of age, gender, and cancer status.Dr. Julie Bruce is funded by the Medical Research Council (MRC) Special Training Fellowship in Health Services & Health of the Public Research

Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy : a randomized controlled trial

Acknowledgments The authors thank John Norrie for advice regarding the reporting of the study, and clinical staff in the Department of General Surgery, Aberdeen Royal Infirmary, for helping with the conduct of the study. This work was supported by a Grant from the Chief Scientist Office (CSO) of the Scottish Government Health Directorates (Grant Number reference CZG/2/498). Jonathan A. Cook held a Medical Research Council, UK, training fellowship (G0601938) while this research was undertaken. The Health Services Research Unit is funded by the CSO of the Scottish Government Health Directorates. The views expressed in this paper are those of the authors and may not necessarily be shared by the funding bodies. The study was overseen by an Advisory Group comprising Professor Marion Campbell (Director, Health Services Research Unit, Aberdeen), Professor John Norrie (CHaRT Director) and Professor Craig Ramsay (Health Care Assessment Programme Director, Health Services Research Unit, Aberdeen). Professor W. Alastair Chambers was the independent chair of the Trial Steering Committee. Contributing surgeons to the SCARLESS study (in alphabetical order): Bassam Alkari, Emad Aly, Norman Binnie, Duff Bruce, Jan Jansen, Peter King, Tim MacAdam, Aileen McKinley, Terry O’Kelly, Ken Park, Abdul Qadir. The National Health Service provided support through the contribution of the following research nurses: Anu Joyson, Hazel Forbes, and Julie Shotton.Peer reviewedPublisher PD

Clinical effectiveness and cost-effectiveness of laparoscopic surgery for colorectal cancer: systematic reviews and economic evaluation.

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Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease : UK collaborative randomised trial

ABSTRACT Objective To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Multicentre, pragmatic randomised trial (with parallel preference groups). Setting 21 hospitals in the United Kingdom. Participants 357 randomised participants (178 surgical,179 medical) and 453 preference participants (261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for >12 months. Intervention The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care. Main outcome measures The disease specific REFLUX quality of life score (primary outcome), SF-36, EQ-5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications. Main results Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 (62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% (59/154) randomised to surgery (14% (14/104) among those who had fundoplication) were taking reflux medication versus 90% (147/164) randomised medical management. The REFLUX score favoured the randomised surgical group (14.0, 95% confidence interval 9.6 to 18.4; P<0.001). Differences of a third to half of 1 SD in other health status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group. Conclusion At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD. Trial registration ISRCTN15517081This study was funded by the NIHR Health Technology Assessment Programme (as part of project no. 97/10/99) and the full project report is published in Health Technology Assessment 2008;12:1/181. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorates.Peer reviewe

The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease – a UK collaborative study

*Corresponding author randomised arm of the trial (178 allocated to surgical management,179 allocated to continued, but optimised,medical management) and 453 recruited to the parallel non-randomised preference arm (261 chose surgical management, 192 chose to continue with best medical management). The type of fundoplication was left to the discretion of the surgeon. Main outcome measures: Participants completed a baseline reflux questionnaire, developed specifically for this study, containing a disease-specific outcome measure, the Short Form with 36 Items (SF-36), the EuroQol-5 Dimensions (EQ-5D) and the Beliefs about Medicines and Surgery questionnaires (BMQ/BSQ).Postal questionnaires were completed at participant specific time intervals after joining the trial (equivalent to approximately 3 and 12 months after surgery).Intraoperative data were recorded by the surgeons and all other in-hospital data were collected by the research nurse. At the end of the study period, participants completed a discrete choice experiment questionnaire. Results: The randomised groups were well balanced at entry. Participants had been taking GORD medication for a median of 32 months; the mean age of participants was 46 years and 66% were men. Of 178 randomised to surgery, 111 (62%) actually had fundoplication.There was a mixture of clinical and personal reasons why some patients did not have surgery, sometimes Objectives: To evaluate the clinical effectiveness, costeffectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies. Design: Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgerybased policy with a continued medical management policy. The economic evaluation compared the costeffectiveness of the two management policies in order to identify the most efficient provision of future care and describe the resource impact that various policies for fundoplication would have on the NHS.Setting: A total of 21 hospitals throughout the UK with a local partnership between surgeon(s) and gastroenterologist(s) who shared the secondary care of patients with GORD.Participants: The 810 participants, who were identified retrospectively or prospectively via their participating clinicians, had both documented evidence of GORD (endoscopy and/or manometry/24-hour pH monitoring) and symptoms for longer than 12 months. In addition,the recruiting clinician(s) was clinically uncertain about which management policy was best.Intervention: Of the 810 eligible patients who consented to participate, 357 were recruited to the related to long waiting times. A total or partial wrap procedure was performed depending on surgeon preference. Complications were uncommon and there were no deaths associated with surgery. By the equivalent of 12 months after surgery, 38% in the randomised surgical group (14% amongst those who had surgery) were taking reflux medication compared with 90% in the randomised medical group. There were substantial differences (one-third to one-half standard deviation) favouring the randomised surgical group across the health status measures, the size depending on assumptions about the proportion that actually had fundoplication. These differences were the same or somewhat smaller than differences observed at 3 months. The lower the reflux score, the worse the symptoms at trial entry and the larger the benefit observed after surgery. The preference surgical group had the lowest reflux scores at baseline. These scores improved substantially after surgery, and by 12 months they were better than those in the preference medical group. The BMQ/BSQ and discrete choice experiment did distinguish the preference groups from each other and from the randomised groups. The latter indicated that the risk of serious complications was the most important single attribute of a treatment option. A within trial cost-effectiveness analysis suggested that the surgery policy was more costly (mean £2049) but also more effective [+0.088 quality-adjusted life-years (QALYs)]. The estimated incremental cost per QALY was £19,000–£23,000, with a probability between 46% (when 62% received surgery) and 19% (when all received surgery) of cost-effectiveness at a threshold of £20,000 per QALY. Modelling plausible longer-term scenarios (such as lifetime benefit after surgery) indicated a greater likelihood (74%) of costeffectiveness at a threshold of £20,000, but applying a range of alternative scenarios indicated wide uncertainty.The expected value of perfect information was greatest for longer-term quality of life and proportions of surgical patients requiring medication.Conclusions: Amongst patients requiring long-term medication to control symptoms of GORD, surgical management significantly increases general and refluxspecific health-related quality of life measures, at least up to 12 months after surgery. Complications of surgery were rare. A surgical policy is, however, more costly than continued medical management. At a threshold of £20,000 per QALY it may well be cost-effective, especially when putative longer-term benefits are taken into account, but this is uncertain.The more troublesome the symptoms, the greater the potential benefit from surgery. Uncertainty about cost-effectiveness would be greatly reduced by more reliable information about relative longer-term costs and benefits of surgical and medical policies. This could be through extended follow-up of the reflux trial cohorts or of other cohorts of fundoplication patients.Peer reviewedPublisher PD

Single port/incision laparoscopic surgery compared with standard three-port laparoscopic surgery for appendicectomy : a randomised controlled trial

PMID: 23111090 [PubMed - indexed for MEDLINE] PMCID: PMC3543288 Free PMC ArticlePeer reviewedPublisher PD

Medical versus surgical management for gastro-oesophageal reflux disease (GORD) in adults

Background Gastro-oesophageal reflux disease (GORD) is a common condition with up to 20% of patients from Westernised countries experiencing heartburn, reflux or both intermittently. It is unclear whether medical or surgical (laparoscopic fundoplication) management is the most clinically and cost-effective treatment for controlling GORD. Objectives To compare the effects of medical management versus laparoscopic fundoplication surgery on health-related and GORD-specific quality of life (QOL) in adults with GORD. Search strategy We searched CENTRAL (Issue 2, 2009), MEDLINE (1966 to May 2009) and EMBASE (1980 to May 2009). We handsearched conference abstracts and reference lists from published trials to identify further trials. We contacted experts in the field for relevant unpublished material. Selection criteria All randomised or quasi-randomised controlled trials comparing medical management with laparoscopic fundoplication surgery. Data collection and analysis Two authors independently extracted data from articles identified for inclusion and assessed the methodological quality of eligible trials. Primary outcomes were: health-related and GORD-specific QOL, heartburn, regurgitation and dysphagia. Main results Four trials were included with a total of 1232 randomised participants. Health-related QOL was reported by four studies although data were combined using fixed-effect models for two studies (Anvari 2006; REFLUX Trial 2008). There were statistically significant improvements in health-related QOL at three months and one year after surgery compared to medical therapy (mean difference (MD) SF36 general health score -5.23, 95% CI -6.83 to -3.62; I2 = 0%). All four studies reported significant improvements in GORD-specific QOL after surgery compared to medical therapy although data were not combined. There is evidence to suggest that symptoms of heartburn, reflux and bloating are improved after surgery compared to medical therapy, but a small proportion of participants have persistent postoperative dysphagia. Overall rates of postoperative complications were low but surgery is not without risk and postoperative adverse events occurred although they were uncommon. The costs of surgery are considerably higher than the cost of medical management although data are based on the first year of treatment therefore the cost and side effects associated with long-term treatment of chronic GORD need to be considered. Authors' conclusions There is evidence that laparoscopic fundoplication surgery is more effective than medical management for the treatment of GORD at least in the short to medium term. Surgery does carry some risk and whether the benefits of surgery are sustained in the long term remains uncertain. Treatment decisions for GORD should be based on patient and surgeon preference

A review of chronic pain after inguinal herniorrhaphy

Background: Chronic pain was believed to be a recognized but infrequent complication after inguinal hernia repair. Evidence suggests that patients with chronic pain place a considerable burden on health services. However, few scientific data on chronic pain after this common elective operation are available. Objectives: To review the frequency of chronic pain and to discuss etiological theories and current treatment options for patients with chronic post herniorrhaphy pain. Materials and Methods: All studies of postoperative pain after inguinal hernia repair with a minimum follow-up period of 3 months, published between 1987 and 2000, were critically reviewed. Results and Discussion: The frequency of chronic pain after inguinal hernia repair was found to be as high as 54%, much more than previously reported. Quality of life of these patients is affected. Chronic pain is reported less often after laparoscopic and mesh repairs. Recurrent hernia repair, preoperative pain, day case surgery, delayed onset of symptoms, and high pain scores in the first week after surgery, however, were identified to be risk factors for the development of chronic pain. Definition of chronic pain was not explicit in the majority of the reviewed studies. Accurate evaluation of the frequency of chronic pain will require standardization of definition and methods of assessment. Prospective studies are required to define the role of risk factors identified in this review

Identification of risk factors by systematic review and development of risk-adjusted models for surgical site infection

Background: Surgical site infections (SSIs) are complications of surgery that cause significant postoperative morbidity. SSI has been proposed as a potential indicator of the quality of care in the context of clinical governance and monitoring of the performance of NHS organisations against targets. Objectives: We aimed to address a number of objectives. Firstly, identify risk factors for SSI, criteria for stratifying surgical procedures and evidence about the importance of postdischarge surveillance (PDS). Secondly, test the importance of risk factors for SSI in surveillance databases and investigate interactions between risk factors. Thirdly, investigate and validate different definitions of SSI. Lastly, develop models for making risk-adjusted comparisons between hospitals. Data sources: A single hospital surveillance database was used to address objectives 2 and 3 and the UK Surgical Site Infection Surveillance Service database to address objective 4. Study design: There were four elements to the research: (1) systematic reviews of risk factors for SSI (two reviewers assessed titles and abstracts of studies identified by the search strategy and the quality of studies was assessed using the Newcastle Ottawa Scale); (2) assessment of agreement between four SSI definitions; (3) validation of definitions of SSI, quantifying their ability to predict clinical outcomes; and (4) development of operation-specific risk models for SSI, with hospitals fitted as random effects. Results: Reviews of SSI risk factors other than established SSI risk indices identified other risk; some were operation specific, but others applied to multiple operations. The factor most commonly identified was duration of preoperative hospital stay. The review of PDS for SSI confirmed the need for PDS if SSIs are to be compared meaningfully over time within an institution. There was wide variation in SSI rate (SSI%) using different definitions. Over twice as many wounds were classified as infected by one definition only as were classified as infected by both. Different SSI definitions also classified different wounds as being infected. The two most established SSI definitions had broadly similar ability to predict the chosen clinical outcomes. This finding is paradoxical given the poor agreement between definitions. Elements of each definition not common to both may be important in predicting clinical outcomes or outcomes may depend on only a subset of elements which are common to both. Risk factors fitted in multivariable models and their effects, including age and gender, varied by surgical procedure. Operative duration was an important risk factor for all operations, except for hip replacement. Wound class was included least often because some wound classes were not applicable to all operations or were combined because of small numbers. The American Association of Anesthesiologists class was a consistent risk factor for most operations. Conclusions: The research literature does not allow surgery-specific or generic risk factors to be defined. SSI definitions varied between surveillance programmes and potentially between hospitals. Different definitions do not have good agreement, but the definitions have similar ability to predict outcomes influenced by SSI. Associations between components of the National Nosocomial Infections Surveillance risk index and odds of SSI varied for different surgical procedures. There was no evidence for effect modification by hospital. Estimates of SSI% should be disseminated within institutions to inform infection control. Estimates of SSI% across institutions or countries should be interpreted cautiously and should not be assumed to reflect quality of medical care. Future research should focus on developing an SSI definition that has satisfactory psychometric properties, that can be applied in everyday clinical settings, includes PDS and is formulated to detect SSIs that are important to patients or health services