Early laparoscopy versus observation for patients with acute

abdominal pain (Protocol)

Malik AI, Tou S, Nelson RL

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2009, Issue 4
http://www.thecochranelibrary.com

Early laparoscopy versus observation for patients with acute abdominal pain (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Early laparoscopy versus observation for patients with acute abdominal pain (Protocol) i
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Early laparoscopy versus observation for patients with acute

abdominal pain

Ali Irqam Malik1 , Samson Tou2 , Richard L Nelson3

1 Department of General Surgery, East Kent Hospitals NHS Trust, Margate, UK. 2 General Surgery, The Ipswich Hospital NHS Trust,
Ipswich, UK. 3 Department of General Surgery, Northern General Hospital, Sheffield, UK

Contact address: Ali Irqam Malik, Department of General Surgery, East Kent Hospitals NHS Trust, Queen Elizabeth The Queen
Mother Hospital, St Peter’s Road, Margate, CT9 4AN, UK. aliimalik@yahoo.com.

Editorial group: Cochrane Colorectal Cancer Group.

Publication status and date: New, published in Issue 4, 2009.

Citation: Malik AI, Tou S, Nelson RL. Early laparoscopy versus observation for patients with acute abdominal pain. Cochrane Database
of Systematic Reviews 2009, Issue 4. Art. No.: CD008035. DOI: 10.1002/14651858.CD008035.

Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
We aim to determine if early laparoscopy (EL) is to be recommended as a management strategy for patients having an emergency
hospital admission with acute nonspecific abdominal pain in comparison with a strategy of traditional active observation (OBS).

Early laparoscopy versus observation for patients with acute abdominal pain (Protocol) 1
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
BACKGROUND
Description of the condition
Acute abdominal pain is a common presenting complaint
contributing to the daily workload of surgery departments (
Schietroma 2007). In some an underlying aetiology becomes ap-
parent soon after hospital admission (e.g. appendicitis, cholecysti-
tis, bowel obstruction, perforated viscus, pyelonephritis) by initial
assessment and routine baseline investigations. In others no obvi-
ous diagnosis can be made by the initial assessment and these pa-
tients are classed as having “nonspecific abdominal pain” (NSAP).
These patients have traditionally been treated with “active obser-
vation” (OBS). This consists of repeated clinical and haematolog-
ical examinations, additional radiological investigations (e.g. ul-
trasound, computed tomography) and/or gynaecological referral,
in order to determine a diagnosis over several days. This can result
in additional costs, lengthening of the duration of hospitalisation,
and ultimate discharge without making a definitive diagnosis.
Description of the intervention
Early laparoscopy (EL) for patients with NSAP has been suggested
as an alternative to active observation. It entails performing routine
initial assessment and if no diagnosis is apparent, this is followed
by laparoscopic examination of the peritoneal cavity within the
first day or two of the admission episode.
How the intervention might work
Laparoscopy allows direct visual inspection of the intraperitoneal
organs for disease pathology. By making an earlier positive diagno-
sis (e.g. appendicitis, cholecystitis, pelvic inflammatory disease in
females) it may allow earlier definitive treatment to be instituted
for the condition. Alternatively if no abnormality is found then
the patient may be reassured and discharged from hospital early
with the knowledge that no serious pathology is present. Both
diagnostic outcomes of EL have the potential to reduce costs by
avoiding additional unnecessary radiological tests and reducing
hospital stay ( Graff 2000, Salky 1998, Sauerland 2006, Sauerland
2006a). Patient satisfaction is expected to be higher with EL since
they may be more likely to have short hospital stay with a clearer
understanding of what is causing their symptoms. There is also
some evidence that laparoscopy for the acute abdomen rather than
open surgery may reduce the risk of postoperative adhesion for-
mation (Majewski 2005).
Why it is important to do this review
There are at least four randomised controlled trials identified in
our rapid scope but to date there is no level one evidence which we
Early laparoscopy versus observation for patients with acute abdominal pain (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
could identify which evaluates the role of early laparoscopy in com-
parison with active observation. Some of the outcomes in individ-
ual studies have been contradictory. For example Schietroma 2007
found a significant reduction in the length of hospital stay (3.1
vs 7.3 days) with early laparoscopy versus active laparotomic-la-
paroscopic observation respectively. However Decadt 1999 found
a hospital stay of 2 days in both groups (p=0.87). The latter study
however did show an increased likelihood of a definitive diagnosis
being established (81% vs 36%, p<0.0001). This was supported
by Schietroma 2007 but neither Gaitán 2002 nor Morino 2006
were able to confirm these findings. These contradictory findings
may be better understood by systematic review and meta-analysis
of the outcomes.
OBJECTIVES
We aim to determine if early laparoscopy (EL) is to be recom-
mended as a management strategy for patients having an emer-
gency hospital admission with acute nonspecific abdominal pain
in comparison with a strategy of traditional active observation
(OBS).
METHODS
Criteria for considering studies for this review
Types of studies
All randomised and non-randomised controlled studies which
have undergone a peer review process will be included in the re-
view.
Types of participants
We will include studies which evaluate those patients with an
emergency admission with “nonspecific abdominal pain” defined
as acute abdominal pain in any part of the abdomen for less than 8
days who fail to have a diagnosis after a short period of admission
with baseline investigations (e.g. routine basic blood tests, erect
chest x-ray, plain abdominal x-ray, urinalysis). Patients in whom
a specific diagnosis has been made by the initial assessment and
baseline investigations or who are deemed to require immediate
laparotomy or who are admitted after blunt or penetrating trauma
will be excluded. Other than this there will be no restrictions on the
type of participants. Studies focusing only on one particular gender
will not necessarily be excluded but the effects if any will be assessed
on the conclusions inferred. There will neither be any restrictions
on the age of participants nor will we exclude participants due to
2
the team under which they are admitted i.e. general surgical or
gynaecology or medical team.
Types of interventions
Early laparoscopy defined as laparoscopic inspection of the peri-
toneal cavity abdomen within 24-48 hours after admission for
acute abdominal pain which may also include a therapeutic pro-
cedure for example appendicectomy, cholecystectomy or ovarian
cystectomy, or may progress to a full laparotomy for diagnostic or
therapeutic reasons.
Observation defined as “usual management” or continued moni-
toring of the vital signs with repeated clinical examination of the
patient with an acute abdomen and which may end with either
hospital discharge after spontaneous resolution of symptoms, or
continued symptoms necessitating further radiological investiga-
tions (e.g. ultrasound, computed tomography), gynaecology refer-
ral, or ultimately a surgical procedure (e.g. laparoscopy or laparo-
tomy).
Types of outcome measures
Primary outcomes
Likelihood of a positive diagnosis, readmission rates, morbidity,
mortality and length of hospital stay.
Secondary outcomes
Number of radiological investigations required; likelihood of di-
agnosis of appendicitis, pelvic inflammatory disease or no diagno-
sis being made; laparotomy rate; recurrent pain in short and long
term; analgesic requirements; patient satisfaction; and cost.
Search methods for identification of studies
Electronic searches
We will search PubMed, EMBASE, Cochrane Controlled Trials
Register, Google Scholar and Scopus for published controlled trials
since 1980 onwards relating to the following keywords: “early la-
paroscopy” or “minimal* invasive*” or “minimal access” and “acute
abdom*”. Additionally the following MESH terms will be utilised:
“Acute Abdomen”, and “Laparoscopy”, “Early Laparoscopy”, or
“Surgical Procedures, Minimally Invasive”. No language restric-
tions will be applied.
Searching other resources
The bibliographies of previous reviews, published RCTs and rele-
vant non-randomised controlled trials will be scanned for further
citations.
Early laparoscopy versus observation for patients with acute abdominal pain (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Data collection and analysis
Selection of studies
Two independent observers (AIM, SIT) will determine if any iden-
tified trial is suitable for inclusion in the review by initially reading
the title and then the abstract. If the title makes it apparent that
the study is not relevant to our review then the abstract will not
be read. Any disagreements between the observers will be resolved
by referral to the senior author (RLN). Full text publications and
abstract-only publications will be considered. The latter will only
be included if additional relevant information on study quality
and data is made available by contacting the authors.
Data extraction and management
Analysis will be done on an intention to treat basis. Patients with-
out endpoints will not automatically be assumed to be treatment
failures but will be subjected to sensitivity analysis. Original data
will be used as available. A pre-made data extraction form will be
utilised to extract data from the studies by two independent ob-
servers (AIM, SIT) with any conflicts on interpretation resolved
by the senior author (RLN).
Assessment of risk of bias in included studies
The Cochrane Collaboration’s two-part Risk of Bias tool will be
used to describe trial quality focusing on six specific domains
namely sequence generation, allocation concealment, blinding, in-
complete outcome data, selective outcome reporting and any other
‘other’ issues specific to a trial. Each domain for each study will
be described by “yes”, “no” or “unclear” if a risk of bias is thought
to be present, absent or uncertain respectively. Scoring approaches
will not be used. The findings will be summarised in a Risk of Bias
table.
Measures of treatment effect
See section on data synthesis below.
Unit of analysis issues
A single outcome measurement from each participant is expected
since all trials identified in the rapid scope are parallel group design.
Therefore no major unit of analysis issues are expected in this
review.
Dealing with missing data
The primary authors will be contacted in order to extract any
missing data if appropriate.
3
Assessment of heterogeneity
The findings will be evaluated for:
1)Presence of statistical heterogeneity in results using the Chi-
squared test for heterogeneity with its p-value,
2)Clinical heterogeneity by inspection of the trial methods.
If heterogeneity is not detected then data will be analysed using a
fixed effects model. If heterogeneity is detected then an attempt
at identifying the source of heterogeneity will be made and either
a random effects model utilised or a qualitative overview of the
findings from the individual studies presented.
Assessment of reporting biases
If more than 10 trials are detected via the literature search then
funnel plots (standard error vs effect size) will be used to check for
the presence of reporting bias.
Data synthesis
For dichotomous variables, relative risks and their confidence in-
tervals will calculated along with number needed to treat (NNT)
or number needed to harm (NNH). For continuous variables,
REFERENCES
Additional references
Decadt 1999
Decadt B, Sussman L, Lewis MP, Secker A, Cohen L, Rogers C, et
al.Randomized clinical trial of early laparoscopy in the management
of acute non-specific abdominal pain. Br J Surg 1999;86(11):
1383–6.
Gaitán 2002
Gaitán H, Angel E, Sánchez J, Gómez I, Sánchez L, Agudelo C.
Laparoscopic diagnosis of acute lower abdominal pain in women of
reproductive age. Int J Gynaecol Obstet 2002;76(2):149–58.
Graff 2000
Graff L, Russell J, Seashore J, Tate J, Elwell A, Prete M, Werdmann
M, Maag R, Krivenko C, Radford M. False-negative and false-
positive errors in abdominal pain evaluation: failure to diagnose
acute appendicitis and unnecessary surgery. Acad Emerg Med 2000
Nov;7(11):1244–55.
Majewski 2005
Majewski WD. Long-term outcome, adhesions, and quality of life
after laparoscopic and open surgical therapies for acute abdomen:
follow-up of a prospective trial. Surg Endosc 2005 Jan;19(1):81–90.
[DOI: 10.1007/s00464-003-9333-0]
Morino 2006
Morino M, Pellegrino L, Castagna E, Farinella E, Mao P. Acute
nonspecific abdominal pain: A randomized, controlled trial
Early laparoscopy versus observation for patients with acute abdominal pain (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
pooled weighted mean differences (WMD) and their confidence
intervals will be calculated.The calculations will be performed us-
ing the RevMan software version 5 provided by the Cochrane Col-
laboration.
Subgroup analysis and investigation of heterogeneity
If heterogeneity is detected statistically then the effect of this on
the results will be determined using the I2 -test.
Sensitivity analysis
An attempt will be made to check if certain trial parameters are
responsible for the findings whether any heterogeneity is found
or not. This will be based on, but may not be limited to, risk of
bias within trials and trial comparison groups (female only trials,
duration of admission before early laparoscopy is performed (e.g.
6 hours vs 24 hours), operation rate in controls).
ACKNOWLEDGEMENTS
None
comparing early laparoscopy versus clinical observation. Ann Surg
2006;244(6):886–8.
Salky 1998
Salky BA, Edye MB. The role of laparoscopy in the diagnosis and
treatment of abdominal pain syndromes. Surg Endosc 1998 July;12
(7):911–4. [DOI: 10.1007/s004649900744]
Sauerland 2006
Sauerland S, Agresta F, Bergamaschi R, Borzellino G, Budzynski A,
Champault G, et al.The EAES clinical practice guidelines on
laparoscopy for abdominal emergencies (chapter 17). In:
Neugebauer EAM, Sauerland S, Fingerhut A, Millat B, Buess G
editor(s). EAES Guidelines for Endoscopic Surgery: Twelve Years
Evidence-Based Surgery. Berlin Heidelberg: Springer, 2006:350–1.
Sauerland 2006a
Sauerland S, Agresta F, Bergamaschi R, Borzellino G, Budzynski A,
Champault G, et al.Laparoscopy for abdominal emergencies.
Evidence-based guidelines of the European Association for
Endoscopic Surgery. Surg Endosc 2006 Jan;20(1):14–29. [DOI:
10.1007/s00464-005-0564-0]
Schietroma 2007
Schietroma M, Cappelli S, Carlei F, Pescosolido A, Lygidakis NJ,
Amicucci G. “Acute abdomen”: early laparoscopy or active
laparotomic-laparoscopic observation?. Hepatogastroenterology
2007;54(76):1137–41.
∗
Indicates the major publication for the study
4
WHAT’S NEW
Last assessed as up-to-date: 30 July 2009.

27 July 2009 Amended Reviewer comments have been utilised to make amendments

27 July 2009 Amended Protocol completed

HISTORY
Protocol first published: Issue 4, 2009

CONTRIBUTIONS OF AUTHORS
Drafting the protocol: AIM, SIT, RNL

DECLARATIONS OF INTEREST
No interests declared

Early laparoscopy versus observation for patients with acute abdominal pain (Protocol) 5
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.