Comparison of health-related quality of life and disability in ulcerative colitis patients following restorative proctocolectomy with ileal pouch-anal anastomosis versus anti-tumor necrosis factor therapy.

BACKGROUND AND AIMS: Health-related quality of life (HRQL) and disability were compared in ulcerative colitis (UC) patients who underwent restorative proctocolectomy versus patients who received treatment with anti-tumor necrosis factor (anti-TNF) agents. PATIENTS AND METHODS: UC patients who underwent restorative proctocolectomy or started anti-TNF treatment between January 2010 and January 2015 were included at two tertiary referral centers. A matched cohort was created using propensity score matching for the covariates disease duration, Montreal classification, age, and sex. HRQL and disability were assessed using the Colorectal Functional Outcome (COREFO), Inflammatory Bowel Disease Disability Index (IBD-DI), EuroQol-5D-3L, and Short Form 36 (SF-36) questionnaires. RESULTS: In total, 297 patients were included, of whom 205 (69%) patients responded. Fifty-nine pouch patients were matched to 59 anti-TNF-treated patients. Pouch patients reported better general health scores (P=0.042) compared with the anti-TNF group (SF-36). No differences were found for the EuroQol-5D-3L and IBD-DI between the two groups. Pouch patients had significantly higher COREFO scores compared with anti-TNF-treated patients for 'stool frequency' (P<0.001), 'antidiarrheal medication use' (P<0.001), and 'stool-related aspects' (P=0.004), of which the latter was because of a higher perianal skin irritation frequency (P<0.001). CONCLUSION: UC patients who underwent restorative proctocolectomy reported a higher bowel movement frequency and more perianal skin irritation compared with anti-TNF-treated patients, but this did not affect overall disease-specific disability outcomes. Patients in the surgery group reported better outcomes for generic health compared with those in the anti-TNF group.

Restorative Proctocolectomy in Elderly IBD Patients: A Multicentre Comparative Study on Safety and Efficacy.

BACKGROUND AND AIMS: Restorative proctocolectomy in elderly inflammatory bowel disease [ IBD] patients is controversial and limited data are available on the outcomes of surgery. The aim of this study was to evaluate the safety, efficacy, and long-term results of ileal-pouch-anal anastomosis in elderly patients, in a multicentre survey from European referral centres. METHODS: The International Pouch Database [IPD] combined 101 variables. Patients aged ≥ 65 years were matched on the basis of open versus laparoscopic surgery with a control group of consecutive younger unselected patients with a ratio of 1:2. Statistical analysis was performed using two-tailed t test, chi square and Fisher's exact tests, Kaplan-Meier function, and log-rank tests where appropriate. RESULTS: In the IPD, 77 patients aged ≥ 65 years [Group A] and 154 control patients [Group B] were identified. Elderly patients had more comorbidities [p = 0.0001], longer disease duration [p = 0.001], less extensive disease [p = 0.006], more previous abdominal operations [p = 0.0006], surgery for cancer or dysplasia more frequently [p = 0.0001], fewer single-stage procedures [p = 0.03], more diversions after ileal pouch-anal anastomosis [IPAA] [p = 0.05], and a higher laparoscopic conversion rate [p = 0.04]. Postoperative complications and pouch failure were similar between the groups, but Group A had more Clavien-Dindo IV-V complications [p = 0.04], and longer length of stay [p = 0.007]. Laparoscopy was associated with a shorter duration of surgery [p = 0.0001], and length of stay [p = 0.0001], and the same complication rate as open surgery. CONCLUSIONS: Restorative proctocolectomy can be performed in selected elderly patients, but there is a higher risk of postoperative complications and longer length of stay in this group. Laparoscopy is associated with shorter operating time and length of stay.

A Multicentre Evaluation of Risk Factors for Anastomotic Leakage After Restorative Proctocolectomy with Ileal Pouch-Anal Anastomosis for Inflammatory Bowel Disease.

BACKGROUND: Anastomotic leakage is a major complication after restorative proctocolectomy with ileal pouch-anal anastomosis [IPAA]. Identification of patients at high risk of leakage may influence surgical decision making. The aim of this study was to identify risk factors associated with anastomotic leakage after restorative proctocolectomy with IPAA. METHODS: Between September 1990 and January 2015, patients who underwent IPAA for inflammatory bowel disease [IBD] were identified from prospectively maintained databases of three tertiary referral centres. Retrospective chart review identified additional data on demographic and surgical variables. Multivariable regression models were developed to identify risk factors for anastomotic leakage. Separate analyses were performed for type of procedure. RESULTS: A total of 640 patients [56.9% male] were included, with a median age of 38 years [interquartile range 29-48]; 96 [15.0%] patients developed anastomotic leakage. Multivariable regression analysis demonstrated that being overweight (body mass index [BMI] > 25], (odds ratio [OR] 1.92; 95% confidence interval [CI] 1.15 - 3.18), and American Society of Anesthesiologists classification [ASA score > 2] [OR 1.91; 95% CI 1.03 - 3.54] were independent risk factors for anastomotic leakage in patients who underwent a completion proctectomy. A disease course of > 5 years [OR 2.34; 95% CI 1.42 - 3.87] and concurrent combination of anti-tumour necrosis factor [TNF] and steroids [OR 6.40; 95% CI 1.76 - 23.20] were independent risk factors for anastomotic leakage in patients who underwent a proctocolectomy and IPAA. CONCLUSIONS: Independent risk factors for anastomotic leakage in IBD patients undergoing IPAA are BMI >25, ASA score >2, disease course > 5 years, and concurrent steroid and anti-TNF treatment, with a different risk profile for one-stage proctocolectomy and completion proctectomy procedures.

Incidence and Severity of Prepouch Ileitis: A Distinct Disease Entity or a Manifestation of Refractory Pouchitis?

BACKGROUND: Restorative proctocolectomy with ileal pouch-anal anastomosis is the operation of choice for patients with treatment-refractory ulcerative colitis. However, after this intervention, up to 50% of patients develop pouchitis. Moreover, a subgroup will also develop inflammation in the afferent ileum proximal to the pouch, a condition named prepouch ileitis (PI). METHODS: Data on 546 patients who underwent ileal pouch-anal anastomosis for ulcerative colitis were retrospectively collected from 3 tertiary inflammatory bowel disease referral centers in the Netherlands, Belgium, and England. PI was considered present if there was endoscopic and histological inflammation in the afferent limb proximal to the pouch. Crohn's disease was excluded by reviewing the histology of colectomy resection specimens. RESULTS: PI was present in 33/546 (6%) patients and all of these had concurrent pouchitis. One hundred forty-four (26%) patients had pouchitis without PI and 369 (68%) patients did not have inflammatory pouch disease. Of the 33 patients with PI, 6 (18%) received no specific treatment, 9 (27%) responded to antibiotics, and 18 (54%) required escalation in therapy to steroids/immunomodulators or anti-tumor necrosis factor agents. Potent immunosuppressive treatment was required more frequently in patients with PI than those with pouchitis alone. CONCLUSIONS: PI is less common and more treatment refractory than pouchitis alone. Once PI is diagnosed, clinicians should be aware that response to antibiotic therapy is less likely than in pouchitis alone. Immunomodulatory therapy and escalation to anti-tumor necrosis factor agents should be considered early in cases of nonresponse. The suggestion that PI represents misdiagnosed Crohn's disease could not be substantiated in our cohort.

Defunctioning Ileostomy is not Associated with Reduced Leakage in Proctocolectomy and Ileal Pouch Anastomosis Surgeries for IBD.

BACKGROUND: Anastomotic leakage is a serious complication after restorative proctocolectomy with ileal pouch-anal anastomosis. Previous studies have shown significantly decreased leak rates in diverted patients with less severe clinical consequences. The aim of this study was to evaluate short- and long-term outcome of selective ileostomy formation in a multicentre cohort of patients undergoing pouch surgery. METHODS: In a retrospective study, 621 patients undergoing pouch surgery for inflammatory bowel disease [IBD] were identified from three large centres. Anastomotic leakage was defined as any leak confirmed by either contrast extravasation on imaging or during surgical re-intervention. RESULTS: In 305 patients [49.1%], primary defunctioning ileostomy was created during pouch surgery and 41 [6.6%] patients received a secondary ileostomy because of a leaking non-diverted pouch. Primary ileostomy formation was associated with male sex, weight loss, American Society of Anesthesiologists score [ASA] > 2, steroid use, one-stage surgery, hand-sewn anastomosis, and blood transfusion. Leak rates were comparable between diverted and non-diverted patients [16.7% vs 17.1%, p = 0.92], which remained unchanged in subgroups with immunosuppressive medication. Having had an ileostomy was demonstrated to be an independent predictor of small bowel obstruction (odds ratio [OR] 2.58, 95% confidence interval [CI] 1.45 - 4.67) and pouch fistulas [OR 3.05, 95%CI 1.06 - 8.73]. The 10-year pouch survival was comparable for patients with and without ileostomy [89% versus 88%, p = 0.718]. CONCLUSIONS: Leakage rates of diverted and non-diverted pouches in IBD patients were similar and relatively high. Defunctioning was independently associated with long-term complications. A staged approach without defunctioning might be the best strategy.

The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019).

BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment. METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm. DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course. TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.

Nonsuturing or Skin Adhesives versus Suturing of the Perineal Skin After Childbirth: A Systematic Review.

BACKGROUND: Suturing of perineal trauma after childbirth can cause problems such as pain, discomfort because of tight sutures, the need for suture removal, and dyspareunia. It is unclear whether leaving the perineal skin unsutured or using skin adhesives might prevent these problems. METHODS: CENTRAL, MEDLINE, EMBASE, CINAHL, and prospective trial registers until January 2013 were searched for (quasi-)randomized controlled trials comparing nonsuturing of the perineal skin or skin adhesives versus suturing of the skin when repairing a second-degree perineal tear or episiotomy. Primary outcome measure was short-term and long-term pain and need for analgesic medication. RESULTS: Four randomized and two quasi-randomized controlled trials (involving 2,922 women) with heterogeneity in contexts, designs, and methodological quality were included. Nonsuturing of the skin leads to less short-term and long-term pain compared to suturing and an increased rate of skin separation. Skin adhesives lead to less short-term pain without an increased rate of skin separation. Nonsuturing or skin adhesives lead to less complaints and there are no other adverse effects. CONCLUSIONS: Nonsuturing of the skin or the use of skin adhesives appears preferable in terms of pain. Nonsuturing could lead to more short-term skin separation when no adhesives are used, but there is no evidence for the clinical importance of skin separation. There is a need for studies with a follow-up of at least 6 months, in which pain is measured homogeneously and for studies comparing the use of skin adhesives with nonsuturing of the skin with the focus on long-term cosmetic results.

The potential benefits and disadvantages of laparoscopic surgery for ulcerative colitis: A review of current evidence.

Up to 35% of patients with ulcerative colitis will require surgery during the course of their disease. Nowadays, a total colectomy with ileal pouch-anal anastomosis is the preferred procedure, which can be performed open or via laparoscopic approach. Since the early '90s, minimally invasive techniques have gained popularity, but the extend of restorative procedures in these patients has restricted the use of laparoscopic approaches mainly to elective procedures in specialised centres. This review discusses the benefits and disadvantages of laparoscopic surgery when compared to open surgery. It presents the current evidence on short-term and long-term post-operative results, functional outcome, fecundity, and costs, for both elective and emergency indications. In addition, the value of new techniques (including single port surgery) and alternative laparoscopic approaches (e.g. ileo-rectal anastomosis, Kock-pouch and appendectomy) will be discussed.