Intervention Protocol

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Planned relaparotomy versus relaparotomy on demand for treatment of secondary peritonitis

  1. Stefano Trastulli1,
  2. Roberto Cirocchi1,*,
  3. Carlo Boselli1,
  4. Giuseppe Noya1,
  5. Salvatore Guarino2

Editorial Group: Cochrane Colorectal Cancer Group

Published Online: 28 FEB 2013

Assessed as up-to-date: 20 AUG 2012

DOI: 10.1002/14651858.CD010396


How to Cite

Trastulli S, Cirocchi R, Boselli C, Noya G, Guarino S. Planned relaparotomy versus relaparotomy on demand for treatment of secondary peritonitis (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD010396. DOI: 10.1002/14651858.CD010396.

Author Information

  1. 1

    University of Perugia, Department of General Surgery, Terni, Italy

  2. 2

    Royal Free Hospital - UCL Partner, University Department of Surgery, London, UK

*Roberto Cirocchi, Department of General Surgery, University of Perugia, Terni, Italy. cirocchiroberto@yahoo.it.

Publication History

  1. Publication Status: New
  2. Published Online: 28 FEB 2013

SEARCH

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. What's new
  7. Contributions of authors
  8. Declarations of interest
 

Description of the condition

Secondary peritonitis is defined as acute peritoneal infection derived from loss of integrity of the gastrointestinal tract or of other infected visceral organs. Perforation of the gastrointestinal tract (e.g. perforated colonic neoplasm) causes the direct transmigration of bacteria from the infected viscera to the peritoneal cavity (Sartelli 2010). In contrast, the term primary peritonitis is used to define a peritoneal mono-microbial infection in which the integrity of the gastrointestinal tract has not been altered (Blot 2005).
Tertiary peritonitis refers to a poorly defined entity indicating a diffuse infection developing after the failure of initial management of secondary peritonitis and it usually occurs in patients affected by several co-morbidities and co-existing other infections and when the control of intra-abdominal sepsis failed (Mazuski 2009).

“Severe secondary peritonitis” are still characterized by high mortality and morbidity rate due to progression in multiorgan failure (MOF) from septic shock (Christou 1993; Lamme 2002). Different Systems are in use to score “Severe peritonitis”; the APACHE II (Acute Physiological and Chronic ill Health Evaluation) is historically the most used in studies/RCTs, but also SOFA, MODS,  SAPS-Score, Mannheim-Peritonitis-Score are frequently used in studies on peritonitis. However today in the surgical literature there is no consensus in the definition of the cut-off for the various degrees of peritonitis severity using the previously cited numerical scores (Jones 1999). Many authors consider peritonitic patients with an APACHE II score ≥20 having a worst prognosis with an increased mortality rate ranging from 55.6% to 100% (Bosscha 1997; Malik 2010; Komatsu 2005; Panhofer 2009). Other authors consider a severe peritonitis the one with patients the APACHE II score more than 10 (van Ruler 2007; Bohnen 1988; Lamme 2004).

 

Description of the intervention

Prompt surgical treatment is, along with intensive resuscitation care, fundamental in the treatment of peritonitis.

The surgical treatment consists in emergency laparotomy to remove or to control the source of infection (source control) and to perform peritoneal washout to reduce the contamination of the peritoneal cavity and to prevent the persistence or recurrence of intra abdominal infection (damage control) (Berger 1998). The choice of the surgical procedure depends on the localization and on the etiology of the infection, on the extent of the peritoneal contamination and pre-existing co-morbidities of the patient (Schein 1999; Wittmann 1996). After the first surgical intervention (source and damage control) it is possible either to plan a relaparotomy regardless the clinical conditions of the patient (planned relaparotomy) or to wait and watch the development of clinical scenario monitoring the patient and deciding whether a relaparotomy is necessary or not (relaparotomy on demand).

In case the infection persists or if a new one arises, a relaparotomy is required (Nathens 1994; Farthmann 1990) because the failure of the initial infection control is the main cause of death and morbidity in these patients (Bosscha 2000). Relaparotomy should be performed within 48 hr after the first operation for peritonitis because delay on re-exploration is associated with increased mortality and morbidity (Koperna 2000).

Monitoring of patients by combining clinical criteria, laboratory, and computed tomography (CT) results makes adequate and timely identification of patients for relaparotomy within the on-demand strategy possible. Moreover, the on-demand strategy allows for a time window to perform less invasive percutaneous, CT-guided drainage of abscesses instead of relaparotomy.

 

How the intervention might work

In 1983 Penninckx introduced the concept of planned relaparotomy strategy for the treatment of severe peritonitis (Penninckx 1983). This approach consists in planning the relaparotomy upon, during or immediately after the first operation for peritonitis and perform it within 1-3 days to inspect and wash the peritoneal cavity until there are no signs of residual peritonitis or of new infective foci (Schein 2002). The rationale behind this is to control the systemic inflammatory response syndrome (SIRS) and preventing it to progress to multiple organ failure. The planned strategy can be performed both by temporary closure of abdomen and with laparostomy techniques (Leppäniemi 2009; Schein 2002). The planned strategy has the advantage to allow the early identification and treatment of persistent peritonitis or new infective foci, but it might increase the number of unnecessary relaparotomies (van Ruler 2007). Moreover it is necessary to consider the morbidity that can arise from the surgical re-exploration (blood loss, damage of edematous bowels and the abdominal wall) that for some scholars increase the systemic inflammatory response. (Sautner 1997, Zügel 2002). In contrast, the on-demand strategy allows to decrease the unnecessary relaparotomies but it increases the risk of not recognizing persistent or new infective process leading to a diagnostic and therapeutic delay (van Ruler 2007).

 

Why it is important to do this review

The debate about the better strategy is already open. In this meta-analysis clinical randomised and non randomised studies that compare the surgical conventional on demand strategy versus scheduled relaparotomy strategy for treatment of peritonitis will be analysed to evaluate the effectiveness of the treatment.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. What's new
  7. Contributions of authors
  8. Declarations of interest

This review aims to determine the outcomes of the planned relaparotomy strategy versus conventional, on demand relaparotomy strategy in the management of secondary peritonitis. The specific outcomes measured were 30-day mortality as primary outcome, per events and per patients complication type and rates, and the economic impact of planned vs on-demand strategy as secondary outcomes.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. What's new
  7. Contributions of authors
  8. Declarations of interest
 

Criteria for considering studies for this review

 

Types of studies

We plan to include both Randomized and non randomised Clinical Trials that compare the use of the planned relaparotomy versus on demand strategy in the management of secondary peritonitis. The non randomised clinical trials might be excluded if a sufficient number of RCT's to address the primary objective of this systematic review will be identified. If the non randomised clinical studies are included, these will be analysed separately from the RCT's. In addition, 30-day mortality rate will be a required item for inclusion of the non-RCT study. In the analysis we will include the studies in which temporary closure of the abdomen or the laparostomy with each technique has been made, provided the relaparotomy has been scheduled and not realized on the basis of clinical, laboratory and radiological findings and then compared with the on demand strategy. No language restriction will be applied.

 

Types of participants

Patients of any age affected by secondary peritonitis requiring emergency surgical intervention. Secondary peritonitis is defined as any intra-abdominal infection involving the peritoneum caused by the perforation, necrosis, ischemia or infection of any of the gastrointestinal organs or of any other intraabdominal organ included the peritonitis secondary to post-operative complications or peritonitis secondary to compartment syndrome or trauma. Exclusion criteria are patients without radical curative intention/approach at primary surgery and without minimum expected survival after primary surgery, or patients on continuous ambulatory peritoneal dialysis (CAPD).

 

Types of interventions

Planned strategy relaparotomies versus on-demand strategy.

Planned strategy relaparotomies is decided upon during or immediately after the first-index operation for peritonitis, when the consultant or a multidisciplinary team (van Ruler 2007) decides to re operate within 1-3 days, irrespective of the patient’s immediate postoperative course. The criteria for re-laparotomy in the on-demand strategy are the significant deterioration or lack of improvement and consist in the relaparotomy decision made assessing the worsening or persistence  of any signs of sepsis, both clinical (including laboratory results) and radiological, including the unchanged or worsened scores of disease severity, after the primary laparotomy (van Ruler 2007; Penninckx 1990; Koperna 2000). The following techniques were included as laparostomy - interventions that included the use of temporary mesh, plastic sheet, wound bags, “intraabdominal vacuum techniques” and cases where the abdomen was left open without any form of mesh or bags and studies that used a zipper or Velcro mesh technique to close the abdomen and packing of the intraperitoneal cavity. Important Co-Interventions with important impact on outcomes will be addressed and extracted: timing and modality of antibiotic therapy, fluid management.

 

Types of outcome measures

 

Primary outcomes

The primary outcome will be 30-day mortality

 

Secondary outcomes

Secondary outcomes are postoperative in hospital complications classified using the Dindo grading system (Dindo 2004). Per patients and per events number of complications were calculated for each Dindo grade including specific abdominal complications of peritonitis-surgery like intra-abdominal abscesses, small bowel fistulae, ventilator-associated complications.Secondary outcomes include also the economic impact of planned vs on-demand strategy. If possible, results from included studies analysing patients with secondary peritonitis and treated by open abdomen techniques will be classified according to the open abdomen classification suggested by Björck 2009 in order to improve the inter-study and prognostic comparability.

 

Search methods for identification of studies

Searches will be carried out using medical subject headings (MeSH) and free text words in combination with the search strategy for randomised and non-randomized trials reported.

The proposed MEDLINE, EMBASE and Cochrane library strategies is given below and will be modified when applied to other databases.

Search Strategy:

MEDLINE (Ovid)

[MP=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier]

1. exp Laparotomy/

2. exp Abdomen/su [Surgery]

3. exp Peritoneal Lavage/

4. (etappenlavage or laparotom* or abdom* surger* or abdom* operation).mp.

5. 1 or 2 or 3 or 4

6. exp Reoperation/

7. exp Recurrence/

8. (relaparotom* or reoperation or repeat surgery or surgical revision).mp.

9. 6 or 7 or 8

10. exp Peritonitis/

11. exp Intestinal Perforation/co [Complications]

12. (peritonitis or peritone* or (abdom* adj3 infection*)).mp.

13. 10 or 11 or 12

14. 5 and 9 and 13

EMBASE (Ovid)

[mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]

1. exp laparotomy/

2. exp abdominal surgery/

3. exp peritoneum lavage/

4. (etappenlavage or laparotom* or abdom* surger* or abdom* operation).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]

5. 1 or 2 or 3 or 4

6. exp reoperation/

7. exp recurrent disease/

8. (relaparotom* or reoperation or repeat surgery or surgical revision).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]

9. 6 or 7 or 8

10. exp peritonitis/

11. exp intestine perforation/co [Complication]

12. (peritonitis or peritone* or (abdom* and infection*)).m_titl.

13. 10 or 11 or 12

14. 5 and 9 and 13

Cochrane Library

#1 MeSH descriptor Laparotomy explode all trees

#2 MeSH descriptor Abdomen explode all trees with qualifier: SU

#3 MeSH descriptor Peritoneal Lavage explode all trees

#4 (etappenlavage or laparotom* or abdom* surger* or abdom* operation):ti,ab,kw

#5 (#1 OR #2 OR #3 OR #4)

#6 MeSH descriptor Reoperation explode all trees

#7 MeSH descriptor Recurrence explode all trees

#8 (relaparotom* or reoperation or repeat surgery or surgical revision):ti,ab,kw

#9 (#6 OR #7 OR #8)

#10 (#5 AND #9)

#11 MeSH descriptor Peritonitis explode all trees

#12 MeSH descriptor Intestinal Perforation explode all trees with qualifier: CO

#13 (peritonitis or peritone* or (abdom* near3 infection*)):ti,ab,kw

#14 (#11 OR #12 OR #13)

#15 (#10 AND #14)

 

Electronic searches

We will search for published and unpublished randomised controlled trials and non randomised controlled trials without language restrictions using the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Colorectal Cancer Group specialised register (September 2000), MEDLINE (1966 onwards), EMBASE (1980 onwards), CINAHL (1982 onwards), LILACS (Literatura Latinoamericana y del Caribe en Ciencias de la Salud), GoogleScholar (http://scholar.google.com), Web of Science and ClinicalTrials.gov.

 

Searching other resources

We will contact the authors of primary trials, pharmaceutical and device companies to identify further published and unpublished studies.

 

Data collection and analysis

Two reviewers (ST and RC) will independently assess the risk of bias for each included RCTs using “The Cochrane Collaboration’s Tool for Assessing Risk of Bias”. Items that will be assessed include: the generation of randomizations sequence, adequacy of allocation concealment, incomplete outcome data, selective outcome reporting and the adequacy of follow up. Given the difficulty of blinding of an invasive procedure, blinding for intervention will not considered in the assessment of bias risk.
Due to the fact that the primary outcome for this study is 30-day mortality and this represent an hard outcome, minimally affected by performance and detection bias, blinding of outcome assessment and data assessors will not be considered in the assessment of risk of bias. Each domain for each study will be described by "High", "Low" or "unclear" if a risk of bias is thought to be present, absent or uncertain respectively. Scoring approaches will not be used. The result of risk of bias assessment will be summarised in a Risk of Bias table.

Observational studies will be assessed for methodological quality using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations. This is a checklist of 22 items useful in the assessment of methodological quality of cohort, case–control and cross-sectional studies (Vandenbroucke 2007).

 

Selection of studies

The titles and abstracts of all potentially relevant trials will be screened by two reviewer (ST and RC). The full text articles of relevant or potentially relevant studies will be obtained. Based on the full text article, two reviewers (ST and NG) will independently determine whether the study meets the inclusion/exclusion criteria. A third author (NG) will independently assess any discordant results. Discrepancies will be resolved through discussion. Agreement between the authors for selected studies will be reported.

 

Data extraction and management

Trial data will be extracted by each author (ST and CB) independently. Any discrepancies will be resolved by a third author (CR). For trials that include patients with multiple diagnoses, data will be extracted for patients with CRLMs. Primary authors will be contacted in order to clarify any issues or obtain additional or missing data, as required.

The following data will be extracted using standardised forms:

1. General study information

title, authors, contact address
source/journal
published/unpublished
year of publication

2. Trial characteristics

method of randomisation/study design
inclusion and exclusion criteria for patient recruitment
sample size
baseline characteristics
withdrawals and losses to follow-up

3. Study details

patient characteristics including age range, sex ratio, APACHE II score, MPI score
specific diagnosis leading to the surgical intervention
number of patients assigned to each treatment group

relaparotomy strategy for on demand and planned relaparotomy

criteria for deciding relaparotomy in the on demand group
details of intervention techniques

number of patients who died in hospital

definition and number of postoperative in hospital complications (retrieved separately per patients and per events)
length of hospital stay, of ICU and surgery department stay related to each intervention
number of patients death after the hospital discharge during the follow up time

data on quality of life after the hospital discharge using a validated scale
direct and indirect cost of two intervention

 

Assessment of risk of bias in included studies

The risk of bias in included RCTs will be assessed using the Cochrane Collaboration's tool Cochrane handbook chapter 8. This involves consideration of six features: sequence generation, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting and ‘other’ potential sources of bias (Higgins 2011).

 

Measures of treatment effect

We will perform the analysis using Review Manager 5 statistical package recommended by the Cochrane Collaboration and using chapter 9 of Cochrane handbook for Systematic reviews of intervention as a guide (Higgins 2011).

Statistical analysis for dichotomous variables will be performed by using the odds ratio (OR) as the smmary statistics and for time to event analysis by calculating the hazard ratio (HR).

We will report study results with their associated 95% confidence intervals

 

Unit of analysis issues

All statistical analyses will be performed on an intention-to-treat basis. Analysis will be performed on a per patient and a per events basis. Statistical methods will include analysis using both relative risk and odds ratio. Fixed effects and the random effects models will both be tested. If these results are not significantly different, the fixed effects model will be reported.
Data will be displayed with Forest plots. Statistical significance will be set as P = 0.10 for testing heterogeneity, and P = 0.05 for all other analyses.

 

Dealing with missing data

The reference lists of all relevant studies found will be screened, and missing data will be sought by contacting the primary authors. Furthermore, pharmaceutical and device companies will be contacted to identify further published and unpublished studies.

 

Assessment of heterogeneity

The Q test will be used to test for heterogeneity between studies. Heterogeneity will be quantified also using I2 statistics.

 

Assessment of reporting biases

The publication bias will be assessed by using the Funnel plot.

 

Data synthesis

Review Manager 5.1 will be used to analyse all primary and secondary outcome data. Meta-analysis will be only performed if all data will be comparable both clinically and methodologically. If included studies are not sufficiently homogeneous to combine in a meta-analysis, the results of included studies will be displayed in a forest plot.

 

Subgroup analysis and investigation of heterogeneity

In order to investigate the effect of treatment in patients with different degrees of severity of peritonitis we per formed a subgroup analysis considering  separately each outcomes in patients with an APACHE II score less than 10 and greater than 10 and for the ones with APACHE II ranging from 10 to 19 and greater than 19. A subgroup analysis was performed also for considering the outcomes of interest in patients younger than 18 years and older then. Where possible a subgroup analysis considering the different closed and open abdomen groups will be realized for each considered outcomes.

 

Sensitivity analysis

Sensitivity analysis are planned to examine the influence of each individual trial and the influence of trial quality on the results of the meta-analysis. Publication bias will to be examined using funnel plots.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. What's new
  7. Contributions of authors
  8. Declarations of interest

None

 

What's new

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. What's new
  7. Contributions of authors
  8. Declarations of interest

Last assessed as up-to-date: 20 August 2012.


DateEventDescription

30 June 2010AmendedConverted to new review format.



 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. What's new
  7. Contributions of authors
  8. Declarations of interest


TASK

Draft the protocol

Stefano Trastulli

Roberto Cirocchi

Develop a search strategy

TSC at CCCG

Search for trials

Stefano Trastulli

Carlo Boselli

Roberto Cirocchi

Salvatore Guarino

Select which trials to include

Giuseppe Noya

Stefano Trasulli

Salvatore Guarino

Extract data from trials

Stefano Trastulli

Salvatore Guarino

Enter data into RevMan

Stefano Trastulli

Roberto Cirocchi

Carry out the analysis

Stefano Trastulli

Interpret the analysis

Stefano Trastulli

Roberto Cirocchi

Draft the final review

Stefano Trastulli

Roberto Cirocchi



 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. What's new
  7. Contributions of authors
  8. Declarations of interest

None known

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. What's new
  8. Contributions of authors
  9. Declarations of interest
  10. Additional references
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Blot 2005
Bohnen 1988
Bosscha 1997
Bosscha 2000
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