SmartPill® as an objective parameter for determination of severity and duration of postoperative ileus: study protocol of a prospective, two-arm, open-label trial (the PIDuSA study)

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Introduction

Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill ^®, a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill ^® immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking.

Methods and analysis

The PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill ^® will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill ^® in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill ^® to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill ^® will be analysed.

Ethics and dissemination

The protocol was approved by the federal authority (94.1.05-5660-8976) and the local ethics committee (092/14-MPG). Findings will be disseminated through publications and conference presentations.

Trial registration number

NCT02329912; Pre-results.

Related collections

Most cited references 38

Record: found
Abstract: found
Article: not found

Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review.

Zhuan Liao, Rui Gao, Can Xu … (2010)

Capsule endoscopy (CE) has been widely used in clinical practice. To provide systematically pooled results on the indications and detection, completion, and retention rates of small-bowel CE. A systematic review. We searched the PubMed database (2000-2008) for original articles relevant to small-bowel CE for the evaluation of patients with small-bowel signs and symptoms. Data on the total number of capsule procedures, the distribution of different indications for the procedures, the percentages of procedures with positive detection (detection rate), complete examination (completion rate), or capsule retention (retention rate) were extracted and/or calculated, respectively. In addition, the detection, completion, and retention rates were also extracted and/or calculated in relation to indications such as obscure GI bleeding (OGIB), definite or suspected Crohn's disease (CD), and neoplastic lesions. A total of 227 English-language original articles involving 22,840 procedures were included. OGIB was the most common indication (66.0%), followed by the indication of only clinical symptoms reported (10.6%), and definite or suspected CD (10.4%). The pooled detection rates were 59.4%; 60.5%, 55.3%, and 55.9%, respectively, for overall, OGIB, CD, and neoplastic lesions. Angiodysplasia was the most common reason (50.0%) for OGIB. The pooled completion rate was 83.5%, with the rates being 83.6%, 85.4%, and 84.2%, respectively, for the 3 indications. The pooled retention rates were 1.4%, 1.2%, 2.6%, and 2.1%, respectively, for overall and the 3 indications. Inclusion and exclusion criteria were loosely defined. The pooled detection, completion, and retention rates are acceptable for total procedures. OGIB is the most common indication for small-bowel CE, with a high detection rate and low retention rate. In addition, angiodysplasia is the most common finding in patients with OGIB. A relatively high retention rate is associated with definite or suspected CD and neoplasms.

0 comments Cited 177 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Defining postoperative ileus: results of a systematic review and global survey.

Ian Bissett, Ryash Vather, Malav S. Trivedi (2013)

There is a lack of an internationally accepted standardised clinical definition for postoperative ileus (POI). This has made it difficult to estimate incidence and identify risk factors and has compromised external validity of clinical trials. To clarify terminology of POI and propose concise, clinically quantifiable definitions. A systematic review extracted definitions from randomised trials published between 1996 and 2011 investigating POI after abdominal surgery. This was followed by a global survey seeking opinions of those who have published in the field. Definitions were extracted from 52 identified trials. Responses were received in the survey from 45 of 118 corresponding authors. Data were amalgamated to synthesise the following definitions: postoperative ileus (POI) "interval from surgery until passage of flatus/stool AND tolerance of an oral diet"; prolonged POI "two or more of nausea/vomiting, inability to tolerate oral diet over 24 h, absence of flatus over 24 h, distension, radiologic confirmation occurring on or after day 4 postoperatively without prior resolution of POI"; recurrent POI "two or more of nausea/vomiting, inability to tolerate oral diet over 24 h, absence of flatus over 24 h, distension, radiologic confirmation, occurring after apparent resolution of POI". Concordance of the latter two definitions with survey responses were ≥75 %. We have proposed standardised endpoints for use in future studies to facilitate objective comparison of competing interventions.

0 comments Cited 151 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

A clinical pathway to accelerate recovery after colonic resection.

Henrik Kehlet, K Jakobsen, M. Werner … (2000)

To investigate the feasibility of a 48-hour postoperative stay program after colonic resection. Postoperative hospital stay after colonic resection is usually 6 to 12 days, with a complication rate of 10% to 20%. Limiting factors for early recovery include stress-induced organ dysfunction, paralytic ileus, pain, and fatigue. It has been hypothesized that an accelerated multimodal rehabilitation program with optimal pain relief, stress reduction with regional anesthesia, early enteral nutrition, and early mobilization may enhance recovery and reduce the complication rate. Sixty consecutive patients undergoing elective colonic resection were prospectively studied using a well-defined postoperative care program including continuous thoracic epidural analgesia and enforced early mobilization and enteral nutrition, and a planned 48-hour postoperative hospital stay. Postoperative follow-up was scheduled at 8 and 30 days. Median age was 74 years, with 20 patients in ASA group III-IV. Normal gastrointestinal function (defecation) occurred within 48 hours in 57 patients, and the median hospital stay was 2 days, with 32 patients staying 2 days after surgery. There were no cardiopulmonary complications. The readmission rate was 15%, including two patients with anastomotic dehiscence (one treated conservatively, one with colostomy); other readmissions required only short-term observation. A multimodal rehabilitation program may significantly reduce the postoperative hospital stay in high-risk patients undergoing colonic resection. Such a program may also reduce postoperative ileus and cardiopulmonary complications. These results may have important implications for the care of patients after colonic surgery and in the future assessment of open versus laparoscopic colonic resection.

0 comments Cited 112 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2016

Publication date (Electronic): 8 July 2016

Volume: 6

Issue: 7

Electronic Location Identifier: e011014

Affiliations

[1 ]Department of Surgery, University of Bonn , Bonn, Germany

[2 ]Clinical Study Core Unit, Study Center Bonn (SZB), University of Bonn , Bonn, Germany

[3 ]Institute of Medical Biometrics, Informatics and Epidemiology, Study Center Bonn, University of Bonn , Bonn, Germany

[4 ]Department of Orthopedics and Trauma Surgery, University of Bonn , Bonn, Germany

[5 ]Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn , Bonn, Germany

Author notes

[Correspondence to ] Dr Tim O Vilz; tim.vilz@ 123456ukb.uni-bonn.de

MC and SW contributed equally.

Article

Publisher ID: bmjopen-2015-011014

DOI: 10.1136/bmjopen-2015-011014

PMC ID: 4947765

PubMed ID: 27401360

SO-VID: c4ba17ad-f737-4786-96a6-93a206966865

Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 30 December 2015

Date revision received : 10 March 2016

Date accepted : 17 March 2016

Comments

Comment on this article

scite_

Cited by 6

See all cited by

Most referenced authors 501

See all reference authors