Psychosocial outcomes following emergency laparotomy (POLO) study: a study protocol for a multicentre mixed-methods prospective cohort study assessing the psycho-social outcomes following emergency laparotomy in adults.

INTRODUCTION: Morbidity from an emergency laparotomy (EmLap) is difficult to define and poorly understood. Morbidity is a holistic concept, reliant upon an interplay of bio-psychosocial outcomes that evolve long after discharge. To date, no previous study has explored the psychosocial outcomes following EmLap as a collective, nor their change over time. This study aims to describe the holistic morbidity following EmLap within the first year following surgery. METHODS AND ANALYSIS: This is a multicentre, mixed-methods prospective 12-month cohort study with two participant populations: patient participants and family caregivers (FCGs). A target of 160 adult patients who undergo EmLap and can give informed consent will be included in the patient participant group. Patient participants will be asked to complete three patient surveys, incorporating validated patient-reported outcome measures (PROMs) to assess bio-psychosocial outcomes (EuroQol five-dimension five-level (EQ5D-5L), Gastrointestinal Quality Life Index-36, Patient Health Questionnaire-9, Generalised Anxiety Disorder 7, International Trauma Questionnaire, Caregiver Interaction Scale and Fatigue Severity Scale) in the 12 months following surgery. A subgroup of 15 patient participants will be asked to take part in two semistructured interviews at 6 and 12 months. A target of 15 associated family caregivers will be included in the FCG group. FCGs will be asked to take part in a semi-structured interview at 6 months to assess the EmLap impact on the wider support network. The primary outcome will be a change in quality of life (EQ5D-5L) at 12 months. Secondary outcomes will be changes in bio-psychosocial status at 3 and 12 months. Qualitative analysis will allow contextualisation of PROMS and further explore themes of EmLap morbidity. It is anticipated that the results of this study will help inform and develop standards of aftercare for future EmLap patients. ETHICS AND DISSEMINATION: This study has received ethical approval (Wales REC7;12/WA/0297) and will be undertaken in accordance with the principles of Good Clinical Practice. We intend to disseminate study results in peer-reviewed journals and medical conferences, as well as a lay report to study participants. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT05281627.

Improving the time to ileostomy closure following an anterior resection for rectal cancer in the UK.

AIM: Delayed closure of ileostomy following an anterior resection for rectal cancer in the UK is common. The aims of this study were (i) to investigate the variation in patient pathways between hospitals, (ii) to identify the key learning points from units with the shortest time to closure and (iii) to develop guidance for a pathway to minimize delay in ileostomy closure. METHOD: This was a mixed methods study. Thirty-eight colorectal units in the UK completed a short online survey. Nine colorectal units in Wales filled in an additional, expanded version of the survey. Semi-structured interviews were performed with clinicians from the six best performing units in terms of timely ileostomy closure. The optimal pathway suggested is based on the best evidence available and the Association of Coloproctology of Great Britain and Ireland guidelines. RESULTS: Qualitative analysis revealed that 5% of units (n = 2) have a local target time for ileostomy closure. Of all units, 90% (n = 34) would consider implementing a pathway if guidelines were developed. In-depth interviews highlighted the importance of a multidisciplinary approach, a dedicated coordinator to facilitate timely booking, and consensus on whether closure should be performed before or after adjuvant chemotherapy. CONCLUSION: There is a lack of national guidance in timing of contrast studies and ileostomy closure. Key aspects to consider are better information at consent regarding stoma closure timing, a dedicated person to track patients and the planning of contrast studies at discharge from initial surgery. With a dedicated approach closure of ileostomy within 10-12 weeks is feasible for most units.

Protocol for a multicentre, dual prospective and retrospective cohort study investigating timing of ileostomy closure after anterior resection for rectal cancer: The CLOSurE of Ileostomy Timing (CLOSE-IT) study.

INTRODUCTION: A defunctioning ileostomy is often formed during rectal cancer surgery to reduce the potentially fatal sequelae of anastomotic leak. Once the ileostomy is closed and bowel continuity restored, many patients can suffer poor bowel function, that is, low anterior resection syndrome (LARS). It has been suggested that delay to closure can increase incidence of LARS which is known to significantly reduce quality of life. Despite this, within the UK, time to closure of ileostomy is not subject to national targets within the National Health Service and delay to closure exceeds 18 months in one-third of patients. Clinical factors, surgeon and patient preference or service pressures may all impact time to closure, yet to date no study has investigated this. The aim of this UK-wide study is to assess time to ileostomy closure and identify reasons for delays. METHODS AND ANALYSIS: A UK-wide multicentre prospective snapshot study, together with retrospective analysis of ileostomy closure through The Dukes' Club Research Collaborative including patients undergoing ileostomy closure in a 3-month period (April to June 2018) and all patients who underwent anterior resection and ileostomy formation over a historical 12-month period (2015). Time to closure and incidence of 'non-closure' will be calculated. Units will be surveyed to determine local clinical and management protocols and barriers to timely closure. Multivariate linear regression analysis will be used to determine factors significantly associated with delay to ileostomy closure. ETHICS AND DISSEMINATION: Study approved by the South West-Exeter Research Ethics Committee and the Health Research Authority. Study results will be submitted for presentation at international conferences and for publication in peer-reviewed journals. Results will be presented to and discussed with the patient and public representatives and relevant national bodies to facilitate the development of consensus guidelines on optimum treatment pathways.

Physiotherapy and Anterior Resection Syndrome (PARiS) trial: feasibility study protocol.

INTRODUCTION: Rectal cancer affects more than 600 patients per year in Wales, with a 5-year survival rate of around 60%. A recent report demonstrated that 19% of patients with bowel cancer had difficulty controlling their bowels after surgery, and these patients were twice as likely to report lower quality of life than those who had control. Nearly all patients will experience bowel dysfunction initially following surgery and up to 25% will experience severe bowel dysfunction on a long-term basis. The aim of this study is to test the feasibility of introducing a simple intervention in an attempt to improve bowel function following surgery for rectal cancer. We propose the introduction of an educational session from specialist nurses and physiotherapists prior to surgery and a subsequent physiotherapy programme for 3 months to teach patients how to strengthen their pelvic floor. METHODS AND ANALYSIS: All patients with rectal cancer planned to receive an anterior resection will be approached for the study. The study will take place in three centres over 12 months, and we expect to recruit 40 patients. The primary outcome measure is the proportion of eligible patients approached who consent to and attend the educational session. The secondary outcomes include patient compliance to the pelvic floor rehabilitation programme (assessed by patient paper or electronic diary), the acceptability of the intervention to the patient (assessed using qualitative interviews) and preoperative and postoperative pelvic floor tone (assessed using the Oxford Grading System and the International Continence Society Grading System), patient bowel function and patient quality of life (assessed using validated questionnaires). ETHICS AND DISSEMINATION: Ethics approval was granted. This feasibility study is in progress. If patients find the intervention acceptable, the next stage would be a trial comparing outcomes after anterior resection in those who have and do not have physiotherapy. TRIAL REGISTRATION NUMBER: ISRCTN77383505; Pre-results.

Argon Beam Coagulator in Breast Surgery: Effect on the Incidence of Breast Seroma.

Although Argon Beam Coagulators (ABCs) are widely used in urological and gynecological procedures, there have been only two studies published so far on their use and benefits in breast surgery. This study compares the incidence of breast seroma following mastectomy upon the use of ABC versus standard monopolar diathermy. This is a retrospective cohort study, with data collected from January 2006 to August 2008 for all patients who underwent a simple mastectomy and axillary surgery. Outcomes included incidence of seroma, amount of drainage on day of discharge, and timing of seroma formation. Fifty-six patients were studied, with 30 undergoing simple mastectomy using ABC diathermy and 25 using simple diathermy. The incidence of postoperative breast seroma development was 30% (n = 9) in the former group and 36% (n = 9) in the latter. In the ABC group, a high postoperative drainage at discharge was predictive of developing a seroma; this was not observed in the monopolar group. The search for methods to reduce the incidence of seroma in breast surgery is ongoing worldwide. Despite a previous report, this study failed to show any significant difference between ABC and monopolar diathermy in the incidence of breast seroma formation following simple mastectomy and axillary surgery. ABC diathermy is more costly, and its use needs to be carefully considered in an era of a stretched National Health Service financial budget.

Missed diagnosis of ankle pseudoaneurysm following ankle arthroscopy: a case report.

BACKGROUND: Pseudoaneurysm formation is rare complication after arthroscopy with incidence of 0.008%, easy to misdiagnose. Its potential catastrophic sequelae should not be underestimated. CASE PRESENTATION: We present a case of missed diagnosis of traumatic anterior tibial artery pseudoaneurysm in a 39 years old female, instead treated as post operative arthroscopy infection. The diagnosis was confirmed with a duplex ultrasound scan and referred to the vascular surgeon with successful out come. CONCLUSION: In view of rare presentation this complication, it is easily missed. According to one study, incidence of anatomic variations of anterior tibial artery range from 2.4 to 12%. Because of this anatomical variation in course along with other factors, pseudoaneurysm formation at ankle is relatively high. In this report, we discuss the diagnosis, anatomical variations of anterior tibial artery and prevention of this complication following arthroscopy. We believe that surgeons operating in this region should take into account these anatomical variations preoperatively.

The risk of oral contraceptives in the etiology of inflammatory bowel disease: a meta-analysis.

OBJECTIVES: Several environmental and genetic factors have been implicated to date in the development of Crohn's disease (CD) and ulcerative colitis (UC). The aim of this study was to provide a quantification of the risk of oral contraceptive pill (OCP) use in the etiology of inflammatory bowel disease. METHODS: A literature search was performed to identify comparative studies reporting on the association of oral contraceptive use in the etiology of UC and CD between 1983 and 2007. A random-effect meta-analysis was used to compare the incidence of UC or CD between the patients exposed to the OCP and nonexposed patients. The results were adjusted for smoking. RESULTS: A total of 75,815 patients were reported on by 14 studies, with 36,797 exposed to OCP and 39,018 nonexposed women. The pooled relative risk (RR) for CD for women currently taking the OCP was 1.51 (95% confidence interval [CI] 1.17-1.96, P= 0.002), and 1.46 (95% CI 1.26-1.70, P < 0.001), adjusted for smoking. The RR for UC in women currently taking the OCP was 1.53 (95% CI 1.21-1.94, P= 0.001), and 1.28 (95% CI 1.06-1.54, P= 0.011), adjusted for smoking. The RR for CD increased with the length of exposure to OCP. Moreover, although the RR did not reduce once the OCP was stopped, it was no longer significant once the OCP was stopped (CI contains 1), both for CD and for UC. CONCLUSIONS: This study provides evidence of an association between the use of oral contraceptive agents and development of IBD, in particular CD. The study also suggests that the risk for patients who stop using the OCP reverts to that of the nonexposed population.

The effect of restorative proctocolectomy on sexual function, urinary function, fertility, pregnancy and delivery: a systematic review.

PURPOSE: This study was designed to evaluate the effect of restorative proctocolectomy on sexual function, urinary function, fertility, pregnancy, and delivery in patients with ulcerative colitis. METHODS: A systematic literature search was performed of articles published between 1980 and 2005 on patients undergoing restorative proctocolectomy for ulcerative colitis reporting data on the outcomes of interest. A random-effect, meta-analytical model was used for pooled estimates and 95 percent confidence intervals. RESULTS: A total of 22 studies, with 1,852 females, were included. Infertility rate was 12 percent before restorative proctocolectomy and 26 percent after, among 945 patients in seven studies. The incidence of sexual dysfunction was 8 percent preoperatively and 25 percent postoperatively (7 studies, n = 419). Two studies (n = 62) reported no urinary dysfunction in patients undergoing restorative proctocolectomy. There was an increased incidence of cesarean section after restorative proctocolectomy. During the third trimester of pregnancy, there was an increase in stool frequency by 1.15 stools per day compared with before pregnancy frequency (n = 49 95 percent confidence interval, 0.28-2.03 P = 0.01 chi-squared statistic, 0.04 P = 0.84). No significant differences were seen in pouch function after vaginal delivery (n = 456; weighted mean difference, 0.23; 95 percent confidence interval, 0.43-0.88; P = 0.49; chi-squared statistic, 1.29; P = 0.26). CONCLUSIONS: The incidence of dyspareunia increases after restorative proctocolectomy. There was a decrease in fertility after restorative proctocolectomy. Pregnancy after restorative proctocolectomy was not associated with an increase in complications. There was an increase in stool frequency and pad usage during the third trimester. Vaginal delivery is safe after restorative proctocolectomy. Pouch function after delivery returns to pregestational function within six months.

A meta-analysis of quality of life for abdominoperineal excision of rectum versus anterior resection for rectal cancer.

BACKGROUND: Avoiding a permanent stoma following rectal cancer excision is believed to improve quality of life (QoL), but evidence from comparative studies is contradictory. The aim of this study was to compare QoL following abdominoperineal excision of rectum (APER) with that after anterior resection (AR) in patients with rectal cancer. METHODS: A literature search was performed to identify studies published between 1966 and 2006 comparing values of QoL following APER and AR. Random-effect meta-analysis was used to combine the data. Sensitivity analyses were performed for larger studies, those of higher quality and those using self-administered QoL questionnaires. RESULTS: The outcomes for 1,443 patients from 11 studies, of whom 486 (33%) underwent APER, were included. QoL assessments were made at periods of up to 2 years following surgery. There was no significant difference in global health scores between APER and AR. Vitality (WMD -9.82; 95% CI -27.01, -2.04, P = 0.01) and sexual function (WMD -2.73; 95% CI -4.93, -0.64, P = 0.01) were improved in the AR patients. Patients with low AR had improved physical function scores in comparison with APER patients (WMD -4.67; 95% CI -9.10, -0.23; P = 0.004). Cognitive (WMD 3.57; 95% CI 1.41, 5.73; P < 0.001) and emotional function scores (WMD 3.51; 95% CI 1.40, 5.62; P < 0.001) were higher for APER patients. CONCLUSION: Overall, when comparing APER with AR, we identified no differences in general QoL following the procedures. Individualisation of care for rectal cancer patients is essential, but a policy of avoidance of APER cannot currently be justified on the grounds of QoL alone.