MR GUY HENRY THOMAS WORLEY (Orcid ID : 0000-0002-8265-7641)
Accepted Article
DR JONATHAN SEGAL (Orcid ID : 0000-0002-9668-0316)
Article type
: Systematic Review
054-2018.R1
Systematic Review
Management of early pouch-related septic complications in ulcerative colitis: systematic review Guy H T Worley, Jonathan P Segal, Janindra Warusavitarne, Susan K Clark, Omar D Faiz
St Mark's Hospital and Academic Institute, Harrow, Middlesex, UK and Department of Surgery and Cancer, Imperial College London, London, UK
Corresponding author: Guy Worley Guarantor of the article:
[email protected]
Omar Faiz
[email protected]
Keywords: ulcerative colitis, restorative proctocolectomy, ileal pouch, surgery, complications, sepsis, leak
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/codi.14266 This article is protected by copyright. All rights reserved.
Abstract
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Introduction It is well established that ileoanal pouch-related septic complications (PRSC) increase the risk of pouch failure. There are a number of publications that describe the management of early PRSC in ulcerative colitis (UC) in small series. This article aims to systematically review and summarise the relevant contemporary data on this subject and provide an algorithm for the management of early PRSC.
Method A systematic review was undertaken in accordance with PRISMA guidelines. Studies published between 2000 and 2017 describing the clinical management of PRSC in patients with UC within 30 days of primary ileoanal pouch surgery were included. A qualitative analysis was undertaken due to the heterogeneity and quality of studies included.
Results 1157 abstracts and 266 full text articles were screened. Twelve studies were included for analysis involving a total of 207 patients. The studies described a range of techniques including imageguided, endoscopic, surgical and endocavitational vacuum methods. Based on the evidence from these studies, an algorithm was created to guide the management of early PRSC.
Conclusion The results of this review suggest that although successful salvage of early pouch related septic complications is improving there is little information available relating to methods of salvage and outcomes. . Novel techniques may offer increased chance of salvage but comparative studies with longer follow-up are required.
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What does this paper add to the literature?
Accepted Article
This is a systematic review of the published literature regarding the management of short term pouch-related septic complications for patients with ulcerative colitis. The appropriate management of post-operative sepsis is crucial to give the best chance of avoiding pouch failure. We present an algorithm for management based on this review.
Introduction Since first described in 1978, restorative proctocolectomy or the ileoanal pouch procedure has been frequently performed as an alternative to total colectomy and permanent ileostomy in patients with ulcerative colitis (UC). (1). The incidence of pelvic sepsis after ileoanal pouch formation approaches 15%, and septic complications account for the majority of pouch failures. Many papers describe the rate and sequelae of early pouch related septic complications (PRSC) but very few empirical studies describe their clinical management in detail (2–6).
This systematic review of the literature aims to identify and summarise empirical studies describing the management of early PRSC.
Method This systematic review was undertaken in adherence with the Preferred Reporting In Systematic Reviews and Meta-Analyses (PRISMA) guidelines and Cochrane Handbook for Systematic Reviews of Interventions(7).
Information sources MEDLINE (1946 to present), Embase (1974 to present) (both searched via Ovid), and Web of Science (1950 to present) were searched systematically as per the terminology in Appendix 1. The Cochrane Database of Systematic Reviews was searched by 'Topic' and articles were hand searched from the references and citing articles of papers which met the inclusion criteria. The last literature search was 21st November 2017.
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Search
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All databases were searched with the intention of high sensitivity and wide capture. The following terms were included as 'exploded' Medical Subject Headings (MeSH) or Keywords terms depending on database, and also as text word searches, using the suffix '.tw.'. These terms were then combined with the Boolean operators 'AND' or 'OR' as follows, and the search filtered by year (2000 to 2017 to focus on contemporary studies), by publication type (Journal Article) and to remove duplicates. No language filter was employed during the initial literature search but only abstracts in English were screened.
Inclusion criteria All articles from peer-reviewed journals which described empirical studies on patients with UC after primary pouch surgery, with an abstract written in English, were included. Studies were required to describe techniques in managing pouch-related septic complications (i.e. anastomotic leak, abscess, sinus, fistula and peritonitis) within 30 days of the primary procedure.
Exclusion criteria Review articles, published abstracts, conference posters, audits, editorials and letters were excluded. Two researchers (GW and JPS) independently reviewed the articles retrieved by the search strategy and resolved disagreements by consensus.
Data collection and abstraction Data were extracted and tabulated in Microsoft Excel (Version 15.18). Data collected included: first author, institution city, year of publication, sample size, study design, gender, age, BMI, diagnosis, pouch configuration, anastomotic technique, operative stages, de-functioning ileostomy at pouch creation, categorisation of leak, diagnostic criteria for PRSC, signs and symptoms of PRSC, diagnostic imaging, diagnostic endoscopy, management techniques, time to diagnosis and treatment, duration of treatment, time to closure of defect, time to discharge, length of follow up and functional outcomes.
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Synthesis of results
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A descriptive synthesis was employed. Meta-analysis was not appropriate due to the extent of heterogeneity within the study designs and reported outcome variables.
Results Study selection A total of 1155 results were obtained from the original database search, with duplicates removed as one of the search filters. Two results were obtained from hand searching. Of these 1157 screened abstracts 798 were excluded, leaving 339 for full text review. Further duplicates were removed from this selection in citation software (Mendeley v 1.14. 2008-2015) leaving 266 full text articles to be assessed for eligibility. After review 254 articles were excluded, leaving 12 for qualitative analysis (see PRISMA flow diagram, figure 1). When the studies are referred to in the results they are referenced in square brackets according to the numbers allocated in table 1, i.e. [2,5]. Other references are included in parentheses.
Study characteristics The 12 included papers were published between 2007 and 2015. Six papers were from Europe and six from North America. Four papers were case reports of novel techniques [2,3,4,10], five were observational studies [5,8,9,11,12] and one was an interventional study [6]. Participants ranged from 1 to 141, with a total of 207 adult participants included across all studies (table 1).
Synthesis of evidence Diagnosis and Investigation The signs and symptoms associated with acute pouch sepsis were described in five papers [3-5,8,12]. Raval et al. stated that 130 of their series of 141 had symptomatic leaks, 67% exhibiting fever, 38% with abdominoperineal pain and 6% perineal abscess. Of 94 patients without a primary defunctioning ileostomy, high frequency of defaection was present in 29%. Kirat et al. reported fever in
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only 19% and abdominal pain in 56% of their 27 patients. One article [4] described the use of digital
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examination of the anal anastomosis in the diagnosis of pouch leaks.
Mennigen et al. reported that three of 12 patients had very mild or absent symptoms, delaying diagnosis until 20, 26 and 50 days following surgery [11]. Raval et al reported 11 of 141 patients had asymptomatic leaks diagnosed on ‘pouchogram’ before ileostomy closure. Sagap et al. categorised symptoms as mild (clinical suspicion without prominent symptoms), moderate (prominent clinical and/or biochemical features) and severe (generalised peritonitis or shock requiring rapid surgery or ITU care).
Computed tomography (CT) was the most common diagnostic imaging modality. Five studies [2,3,5,9,11] described using CT diagnosis and two [2,11] augmented CTs with contrast enemas. Three studies described routine use of water-soluble contrast enema radiography or 'pouchogram' to diagnose leaks [5,10,12]. Pouchoscopy was used to diagnose or confirm a leak in six studies [2,5,6,8,9,11]. Mennigen et al. reported routine pouchoscopy before discharge.
Time from pouch formation to diagnosis of leak was presented in seven studies [2,4,9-12]. Three case studies [2,4,10] quoted 14, 10 and 5 days respectively, and the case series papers [1,9,11,12] presented medians of 25, 19, 14 and mean 11.5 days respectively. The mean time to diagnosis from these six papers was 18 days.
Categorisation/site of leak Only Raval et al. presented a categorisation of leaks: either ileo-anal anastomosis (IAA) with (21%) or without (33%) abscess; pouch-cutaneous fistula (10%); pouch-vaginal fistula (12%); radiologic leak (8%) or pouch body leak (16%). Kirat et al reported larger abscesses in their group undergoing CTguided percutaneous drainage (7.7cm) than those undergoing trans-anastomotic drainage (5.1cm). In Mennigen et al's series of 12, five had IAA dehiscence with associated abscess, three had pouch body leaks, two had fistulas and three had abscesses without evidence of leak. Kirat et al's series only described leaks from the 'tip' (blind end) of the J pouch, whereas the cumulative 22 patients from the Dutch trials [3,8,11] only dealt with low leaks, i.e. the IAA or just above.
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De-functioning ileostomy and pouch catheter use
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The rate of primary de-functioning ileostomy varied between 26% and 100%. All of Kirat et al's 27 patients with leak from the blind end of the pouch were primarily de-functioned, compared to four of 15 in Gardenbroek et al's series of anastomotic leaks. Not all patients without a primary ileostomy were subsequently de-functioned: Raval et al. reported 63% of 141 patients were de-functioned with an ileostomy, but 42 of the remaining 47 leaks were managed with a pouch catheter and drainage. Five required an ileostomy and washout within 24 hours for generalised peritonitis. Gardenbroek et al. managed two patients with short-term Endo-SPONGE® treatment without defunctioning at all. In one of these patients the initial closure was successful, and the second required formation of an ileostomy and a second period of Endo-SPONGE® treatment before successful closure of the defect. Mennigen et al. managed one patient without ileostomy when there was an abscess but no leak present at abdominal washout.
Percutaneous radiological drainage Percutaneous CT-guided drainage of peri-pouch abscess was reported in five papers. Thosani et al. described the use of CT-guided percutaneous drainage after primary closure of the anastomotic defect with an over the scope clip (OTSC). Kirat et al reported that two of 18 patients developed pouch-cutaneous fistula along the trans-gluteal CT drainage track. Both healed with conservative management and drainage of the associated sepsis
Trans-anal drainage Trans-anastomotic drainage of peri-pouch abscesses was reported in three papers. Raval et al. stated the indication for trans-anastomotic drainage was anastomotic dehiscence. Only Varadarajulu et al. described peri-pouch abscess drainage endoluminally without a pre-existing anastomotic defect by endoscopic ultrasound guided drainage [9]. Kirat et al compared the non-randomised use of percutaneous vs trans-anastomotic drainage of abscesses and found no difference in outcome.
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Endo-cavitational vacuum therapy
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Five papers reported the use of vacuum therapy. All specified that this is only appropriate for low pelvic leaks due to technical limitations and to avoid exerting suction on abdominal small bowel. Two approaches were described – long and short term. The long-term method involved EndoSPONGE® change every three to four days, reducing sponge size until a very small cavity remained, often with a persisting sinus. The median time from diagnosis to closure was 70 days. Gardenbroek et al. and Verlaan et al's short-term technique (three to six sponge changes to clean and encourage healing before early surgical closure of the defect) resulted in a time of 48 (from diagnosis) and 14 days (from start of treatment) to resolution [8,11].
Abdominal re-operation Five studies described re-operation within 30 days [4,5,11,12], excluding surgery only to form a defunctioning ileostomy. The indication for abdominal salvage was peritonitis, abscess not amenable to radiological drainage or high leak [2,7]. Maruthachalam et al. described an initial ileostomy formation and pelvic drainage which failed, so the IAA was disconnected and pouch brought out as a mucus fistula [4]. The pouch was re-connected 12 months later and the technique resulted in good anorectal physiology at 18 months follow-up. Kirat et al. reported the rate of intervention required after failed local drainage. Trans-anal drainage failed in 13 patients (24.5%) of whom three had a redo pouch, one had their pouch mobilised and an ileostomy formed, and six had their pouches excised. Of three failed CT-guided drainages (17%), two had a subsequent re-do pouch performed.
Sagap et al. reported that abdominal re-operation was significantly associated with failure on univariate logistic regression, demonstrating 41% failure rate. Fifty-five of 157 patients required a laparotomy, either after failed drainage or as a primary procedure in 22. None of the studies described pouch excision within 30 days of the primary procedure.
Quality of life and functional outcome Nine studies stated their length of follow-up (table 2). Three papers reported functional outcomes [4,5,11]. Mennigen et al's paper reported no statistically significant difference in Öresland, SIBDQ and GIQLI functional scores. The median frequency in the PRSC group was seven, compared to six for
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controls. Kirat et al's article also reported no significant difference in frequency, urgency, incontinence, seepage or pad use; neither was there significance difference between Cleveland
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Clinic scores, quality of health or sexual function. Maruthachalam et al's case report on pouch salvage by mucus fistula resulted in good capacity and compliance.
Pouch failure Six papers presented failure rate [1,2,5-7,11]. Sagap et al. reported 75.8% of pouches were salvaged. On multivariate analysis – fistula, trans-anal drainage, delayed ileostomy closure, new ileostomy diversion and hypertension were associated with failure. Based on these factors they developed a predictive score.
Raval et al. reported 84% with a functioning pouch from their sample, using multiple treatment techniques. Stapled anastomoses fared better than hand-sewn (93% vs 72% salvaged). There was no statistically significant difference in outcome between patients who had no ileostomy when PRSC was diagnosed, or those who had PRSC diagnosed before or after ileostomy closure (83%, 85%, 85% respectively). They reported improved rates of salvage from 67% between 1981 to 1984 to 88% between 2001 to 2003.
Of Kirat et al’s series of 27 patients with leaks from the blind end of the J pouch, one patient had excision and ileostomy, one patient was still awaiting stoma closure and the remaining 25 had functioning pouches at 3.2 year mean follow-up.
Mennigen et al. reported four pouch failures out of 12 patients with PRSC. Each had at least three procedures before failure and three had abdominal salvage attempts. Kirat et al. reported 75.5% and 83% success for trans-anal and percutaneous CT-guided drainage respectively, with a mean followup of 3.1 years. In Gardenbroek et al’s comparison of short-term Endo-SPONGE® treatment 14 of 15 patients had a functional pouch compared with 24 of 28 with the long-term technique. The median follow-up in their intervention group was significantly shorter at 25 compared to 104 months.
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Discussion
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It is well established that PRSC increases the risk of pouch dysfunction and failure (2–6). However, these complications are not homogenous and neither is the clinical management.
Only one study reported here described a categorisation of the nature of pouch leaks. Such a classification might improve the quality of reporting and homogeneity in the literature for pouch surgery. The International Study Group of Rectal Cancer categorisation of leaks is inadequate for ileoanal pouches as it does not account for the anatomic site, which guides the approach to treatment, albeit the vast majority are from the pouch-anal anastomosis (8).
Whether defining early sepsis as within 30 days, or until planned closure of ileostomy (i.e. 3 months), both definitions refer to sepsis that is a direct result of the operative procedure. This is in comparison with a second peak of PRSC in patients who develop de novo sepsis several years after pouch formation. Some of these cases are attributed to Crohn’s disease, but recent literature suggests that this diagnosis is over used (9).
Many factors influence the the magnitude of the pouch septic insult. These include the time to diagnosis of the leak, the presence or otherwise of a defunctioning ileostomy, anatomical site and size. A leak from the tip of the J is generally a very different clinical scenario to a leak from the IAA. Further studies are required to follow up cases of PRSC with prospective data on different sepsis characteristics and management to accurately assess the correlation with outcome. The rate of successful salvage has improved over time, and now ranges between 75 and 85% (10). The need for laparotomy or trans-anal drainage, however, was consistently associated with failure in this review.
The clinical burden of insidious leaks is unknown. Patients who are asymptomatic until reversal of stoma ileostomy may well have had ongoing low-grade sepsis. Roughly 8% of Raval et al’s series were asymptomatic, with an abnormal pouchogram before reversal of ileostomy. It is not known how many of their patients developed sepsis after ileostomy closure with a normal pouchogram, but it has been demonstrated in other studies that pouchogram has poor sensitivity for the detection of anastomotic leaks (11,12). Only Mennigen et al’s paper describes the routine use of endoscopy to
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review the integrity of the pouch before discharge. Only one study describes the use of routine imaging in the early post-operative period before discharge, as opposed to before ileostomy closure.
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Chronic low grade sepsis can be asymptomatic or misdiagnosed as chronic pouchitis (13), and it may be appropriate to incorporate early prophylactic pouch imaging to detect silent leaks, with the intention of acute anastomotic repair or vacuum therapy to prevent the influence of insidious septic exposure on the pouch. There is very little mention of the routine examination of pouches in the post-operative period, and the sensitivity of digital examination to detect ileo-anal anastomotic defects in pouches is not known.
Managing PRSC without a diverting ileostomy continues to be contentious.. It is becoming more popular to undertake pouch surgery without a de-functioning ileostomy (14) and several of the studies included in this review
describe the successful management of PRSC without a de-
functioning stoma [2, 6, 10]. As with selecting patients for primary pouch formation without ileostomy, the management of leaks without a de-functioning ileostomy must be assessed on a case by case basis, taking in to account patient factors (no steroid use, good nutritional status, nonsmoker) and operative factors (tension free anastomosis, good perfusion etc). One of the arguments in favour of forming an ileal pouch without de-functioning is that a leak is likely to be more clinically apparent, and thereby manifested earlier. The current progression of techniques towards trans-anal dissection, single circular stapled anastomosis and the use of Endo-SPONGE® for leak control go hand in hand with the ‘modern two-stage’ approach to pouch formation; i.e. colectomy with ileostomy followed by proctectomy and pouch formation without ileostomy. The novel use of the Endo-SPONGE® device to clean the cavity and promote healing before closure in Dutch studies shows promising results in terms of early healing, but as yet there are no published follow up data describing functional outcomes. Further studies are required to investigate the subsequent functional outcome depending on the time taken to resolve sepsis and the technique used. As stated previously, a published categorisation of pouch leaks would add homogeneity to future research.
Based on the evidence collated here and the experience of our own institution we present an algorithm for the management of early PRSC (figure 2). Trans-gluteal image guided drainage should be avoided if possible because of potential fistulation along the drain tract. For a pelvic abscess cavity without a visible staple line defect or communicating sinus, controversy exists as to the best management. If transcutaneous drainage is performed in the context of a communication with the
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pouch this may result in an extrasphincteric fistula and should be avoided. If a small communication is found, it is possible to slightly dilate it and introduce an Endo-SPONGE®. Algorithms have been
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published previously following review of the techniques for all pouch complications, but they either do not focus specifically on early PRSC or do not include the use of Endo-SPONGE® therapy (10,15,16).
The limitations of this review lie with the quality of the studies reported. The relative lack of published data available in this area should prompt future research aiming to establish the most effective management of early PRSC by correlating interventions with outcome measures.
Conclusion The results of this review
suggest that
successful salvage of early pouch related septic
complications is improving. However, there is a paucity of research investigating salvage techniques and outcomes. Novel techniques may offer an increased chance of salvage but comparative studies with longer follow-up are required.
Author Contributions GW conceived the study, performed the literature search, extracted and analysed the data, drafted the manuscript and approved the final version for publication. JS performed the literature search, extracted and analysed the data, critically appraised the manuscript and approved the final version for publication. JW and SKC critically appraised the manuscript and approved the final version for publication. ODF conceived the study, critically appraised the manuscript and approved the final version for publication.
Conflicts of Interest None
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Sahami S, Buskens CJ, Fadok TY et al. Defunctioning Ileostomy is not Associated with Reduced Leakage
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Table 1 Study Characteristics. If the study included more than one pathology, then the number of patients with UC is included in parenthesis.
Author
Country
Year of Publication
Patients studied (n)
Female Average Gender Age (%)
41
Average Functional Study summary Follow Up outcomes (Months) reported?
38
Factors associated with failure in managing pouch sepsis
66
No
1.Sagap (17)
USA
2006
157 (85 UC + 24 I/UC)
2.Raval (10)
Canada
2007
141 (131 UC)
43
36
Individualised management of leaks
36
No
3.Van Koperen (18)
Holland
2007
2 (2 UC)
50
34
Long course Endo-SPONGE® therapy
NR
No
4.Maruthachalam (19)
UK
2008
1
N/A
59
Interim pouch salvage as a mucus fistula
18
Yes
48
37
Management of leaks from the tip of the J pouch
38
Yes
5.Kirat (20)
USA
2011
27 (22 UC)
6.Mennigen (21)
Germany
2011
12 (12 UC)
50
34.5
Function after successful management of PRSC
23.5
Yes
7.Kirat (22)
USA
2011
71 (61 UC post-op histology)
30
37
CT vs transanastomotic drainage of pouch abscesses
45
Yes
4.5
No
8.Verlaan (23)
Netherlands
2011
6 (5 UC)
17
50
Early closure of anastomotic defect after short course Endo-SPONGE® therapy
9.Varadarajulu (24)
USA
2012
1
NR
NR
EUS guided drainage of pouch abscess
NR
No
10.Srinivasamurthy (25)
UK
2012
6 (1 UC)
N/A
50
Endo-SPONGE® therapy in pelvic leaks
41
Yes
25
No
1.5
No
11.Gardenbroek (26)
Netherlands
2015
15 (9 UC)
20
37
Early closure of anastomotic defect after short course Endo-SPONGE® therapy in comparison with standard treatment
12.Thosani (27)
USA
2015
1
N/A
50
Over the scope clip closure of anastomotic defect
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Quality of life outcome reported?
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
Table 2 Functional Outcomes
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Author
F/U
Maruthachalam
1.5y
Transanal Drainage
Mean
CT Drainage
Mean
4y
Score Used
Score outcome
Daily Stool Frequency
Urgency
-
-
NR
NR
-
-
7.6 3.6
-
-
Öresland
Seepage
Incontinence
Pads
Day
Night
Day
Night
‘complete continence’
NR
NR
NR
NR
7.5%
2.5%
35.1%
NR
17.9%
NR
7.9 3.3
6.2%
6.2%
31.2%
NR
37.5%
NR
Mean 8.2
7
NR
NR
NR
NR
NR
NR
(0-16; 0 optimum)
Mean 6.6
6
NR
NR
NR
NR
NR
NR
-
-
8.4 4.6
15.4%
0
18.2%
25%
8.3%
8.3%
-
-
8.8 10
4.3%
2.1%
23.9%
30.4%
19.6%
21.7%
NR
‘remain[s] continent throughout an 8-h shift at work’
NR
NR
NR
NR
Kirat 3y
Sepsis
Mennigen
1y Controls
Salvage
Mean
3.2 y
Kirat Controls
Srinivasamurthy
Mean
5.6y
NR
-
-
6
Table 3 Quality of Life Outcomes Author
Subgroup
Questionnaire
P Value
0.7 0.2
Transanal Drainage Kirat
Outcome
CGQL
0.9 0.7 0.1
CT Drainage Sepsis
SIBDQ
5.0
Controls
(1-7; 7 optimum)
5.5
Sepsis
GIQLI
95.8
Controls
(0-144; 144 optimum)
107.3
0.20 Mennigen 0.12
0.8 0.3
Salvage Kirat
CGQL Controls
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0.67 0.8 0.2
Accepted Article
Figure 1: PRISMA flow diagram
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Accepted Article
Figure 2. Algorithm for the management of early pouch sepsis. *See 'presentation' in results section. ☩As per Gardenbroek et al (16). ☨Percutaneous drains should be removed as quickly as possible.
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Appendix 1.
Accepted Article
Search strategy: 1. exp Colitis, Ulcerative/ 2. ulcerative coliti*.tw. 3. 1 or 2 4. exp Colonic Pouches/ 5. exp Proctocolectomy, Restorative/ 6. ("restorative proctocolectomy" or "RPC" or "ile* pouch anal anastomosis" or "IPAA" or "ile* pouch" or "j pouch" or "s pouch" or "w pouch" or "h pouch").tw. 7. 4 or 5 or 6 8. 3 and7 9. exp Anastomotic Leak/ 10. exp Sepsis/ 11. exp Abscess/ or exp Abdominal Abscess/ 12. exp Postoperative Complications/ 13. ("leak*" or "collection" or "sac* collection" or "abscess" or "fistula*").tw. 14. ("pouch related septic complications" or "PRSC").tw. 15. "pouch sepsis".tw. 16. 9 or 10 or 11 or 12 or 13 or 14 or 15 17. 8 and 16 18. remove duplicates from 17 19. 18 and 2000:2017.(sa_year). 20. 19 and "Journal: Article" [Publication Type]
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