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Recent A

nces in A

hesi

n Preventi

per

our, so t

10–12

ours postoperation,

itt

e, i

, cr

sta

tion wou

t in t

e pe

vis [7,8]. Peritonea

e as

as 5–7

days, thereby allowing for an extended period of time for ﬁ

brin outpouring

rom t

ama

sur

aces to interconnect wit

acent structures in t

peritonea

cavit

to a

esion

ormation [9]. T

ere

ore, postsur

ica

instillates with prolon

ed peritoneal residence times should theoreticall

more success

at preventin

esions at

sur

ica

nonsur

ica

sites.

nter

nterge

ution is an aqueous so

ution o

uronic aci

(HA) t

een ionica

y cross-

y t

e a

ition o

erric c

ori

e so

ution. HA is a

inear po

ysacc

ari

e wit

repeating

isacc

ari

e units compose

ium

D-g

ucuronate an

N-acety

-D-g

ucosamine. It is a major component o

many

body tissues and ﬂ

uids, where it provides mechanically protective and physi-

y supportive ro

es. T

e viscosity an

intraperitonea

resi

ence time o

HA so

ution can

ramatica

y increase

y ionic cross-

ing wit

erric

ion. Ionic cross-

ing

etween t

e car

oxy

ate groups on t

e HA an

e triva

ent iron (Fe

cant increase in solution viscosity

intraperitonea

resi

ence compare

to t

e origina

HA so

ution. T

ionica

y cross-

Interge

ution

een

oun

to prevent or re

uce

esion

ormation in prec

inica

anima

s w

ere HA

itt

e or no

ect [10].

aparotomy Stud

he clinical safet

and effectiveness of Inter

el solution was initiall

de monstrated in a sin

le-center pilot stud

involvin

23 patients (Inter

olution

roup

13; lactated Rin

er’s solution

roup

10). After laparotom

00 mL of stud

device was instilled [11]. At second-look laparoscop

, 4–12

weeks after laparotomy, patients treated with Intergel solution had signiﬁ

cantl

fewer adhesions than control patients. Adhesion extent and severit

were also signiﬁ

cantly reduced. A multicenter study was performed to conﬁ

nd extend the results of the pilot stud

wo multicenter studies (one in the United States and one in Euro

e) to

assess the safety and efﬁ

cacy of Intergel solution to prevent or reduce adhe-

ions in patients under

oin

peritoneal cavit

sur

laparotom

have

een completed [12,13]. These studies used a third-part

blinded, parallel-

group, randomized, and controlled design. A statistically signiﬁ

iff

n adhesion burden was found between Inter

el solution and control (lactated

er’s solution). The incidence, severit

, and extent of postsur

ical adhe

sions were signiﬁ

cantly reduced in the Intergel solution group compared to

https://t.me/med1917

4 G.S. diZere

a and M. Korell

actate

Rin

er’s so

ution

roup. T

e proportion o

sites wit

re-

orme

adh

esions was re

uce

31%, an

e proportion o

sur

ica

site a

esions

as re

uce

23%. A re

uction in a

esions wit

Inter

ution was a

oun

or su

groups o

patients

ase

on t

e surgica

proce

ure per

orme

omectom

, a

esio

sis, tu

proce

ures, an

ovarian proce

ures.

e e

ect o

Inter

ution on re

ucin

nexa

esions was s

own

by a signiﬁ

cant reduction in the American Fertility Society (AFS) score for

nexa

esions compare

actate

Ringer’s so

ution. T

e minimum

nexa

esion score o

e ri

t an

t a

nexa was re

uce

59%

owing a

ministration o

Interge

ution. In a

ition, t

e num

er o

atients w

poor surgica

outcomes as evi

ence

y t

e presence o

erate or severe a

esion scores at secon

aparoscopy was re

uce

aparoscopy Stud

o evaluate the safet

and effectiveness of Inter

el administered at the

ime of laparoscop

, a multicenter randomized, parallel-

roup, placebo-

controlled study was performed to assess the safety, compatibility, and efﬁ

cacy

f Inter

el solution compared with lactated Rin

er’s solution in patients

nder

oin

necolo

ical sur

laparoscop

[14]. Inter

el solution or

actated Rin

er’s solution (300 mL) was instilled into the peritoneal cavit

atients immediatel

prior to termination of laparoscop

. A follow-up lapa-

oscop

was conducted 6–12 weeks later. Videotapes and drawin

enerated

from the laparoscopies were assessed by a masked reviewer. Efﬁ

cacy was

easured b

the method of the American Fertilit

Societ

, applied to 23 ana-

omical sites includin

both pelvic and upper abdominal locations: the modi

ed AFS score (mAFS). Additional variables, including the proportion of sites

ith adhesions, the extent of adhesions, and the severit

of adhesions, were

etermined. The stud

evaluated 221 patients (Inter

el solution

roup: 116;

actated Rin

er’s solution

roup: 105) in 11 centers throu

hout the United

tates. The mAFS adhesion scores at baseline for treated and control

roups

were signiﬁ

cantly different, precluding meaningful analysis of the total study

ulation (1.39 vs 0.98,

0.042

f the sur

ical sub

roups, patients havin

ovarian or paratubal c

stecto-

mies had mAFS adhesion scores that were not signiﬁ

cantly different at base-

ine, allowin

for further anal

sis. For this sub

roup, at second-look

laparoscopy, mAFS scores were signiﬁ

cantly lower in the Intergel solution

group than in the control group (Figure 6.1). In addition, there were signiﬁ

ifferences in mAFS scores between

roups at second-look laparoscop

for de

ovo adhesions as well as for adhesions at the sur

ical sites (Fi

ure 6.2).

verall reductions were observed in AFS

(

62%

)

, mAFS

(

71%

)

, incidence

(

61%

)

extent (60%), and severity (69%) of adhesions (Figure 6.3). The safety proﬁ

or the entire stud

population of patients treated with Inter

el solution was

https://t.me/med1917

Recent A

nces in A

hesi

n Preventi

Interge

Lactate

Ringer's

mAF

Baseline

ow-up

< 0.005

ure 6.1. Results are shown for patients undergoing ovarian or paratubal c

stectom

who

received 300 mL of either Inter

el Adhesion Prevention Solution or lactated Rin

er’s solution

at the end o

the laparoscop

(baseline). Six to 12 weeks later the patients had a

ollow-up

laparoscop

. Even though the modi

ied adhesion scores

or 23 di

erent anatomical sites

throu

hout the entire pelvis and abdomen (mAFS) were not different at baseline, the mAFS

scores were signi

icantl

erent at

ollow-up laparoscop

(14).

Re-

ormed De Novo Surgical Sit

Reduction mAFS

-v

alu

98 0.009 0.005

Figure 6.2. Results are shown for patients undergoing ovarian or paratubal cystectomy who

received 300 mL of either Intergel Adhesion Prevention Solution at the end of laparoscopy.

The patients who received Intergel had a statistically significant reduction in de novo and

sur

ical site adhesions compared to those who received lactated Rin

er’s solution as measured

at 23 different anatomical sites throughout the abdomen and pelvis (14)

https://t.me/med1917

6 G.S. diZere

a and M. Korell

(

)

Re-formed De Novo Sur

ical Site

Re-

ormed De Novo Sur

ical Sit

Re-

ormed De Novo Sur

ical Site

uction mAFS

-v

alu

98 0.009 0.005

(

)

% Re

uction in Proportio

P-value 0.163 0.016 0.003

(

)

uction in Severit

Score

P-va

ue 0.141 0.002 0.002

igure 6.3. Results are shown for patients undergoing ovarian or paratubal cystectomy who

eceived 300 mL of Intergel Adhesion Prevention Solution at the end of the laparoscopic pro

edure. The incidence (a), extent (b), and severity (c) of de novo and surgical site adhesions

ere significantly reduced in the patients who received Intergel compared to lactated Ringer’s

ution (14)

https://t.me/med1917

Recent A

nces in A

hesi

n Preventi

compara

e to t

at o

patients treate

wit

actate

Rin

er’s so

ution. Inter

ution was sa

e an

compati

e wit

aparoscop

se o

Inter

een associate

wit

rare cases o

ate-onset (postop

erative days ~3–5), nonspeciﬁ

c, diffuse pelvic pain that is self-limited, usually

pontaneous

reso

vin

in 3 to 5

s. A

pica

lly

e, t

ese

atients can have elevated tem

eratures in the

resence of a normal white

count,

istin

uis

rom intraperitonea

ection. In t

e a

sence

of other ﬁ

ndings, the pain in these patients usually resolves spontaneously,

atin

e nee

or sur

ica

intervention. Due to t

e a

ove, Inter

was

untari

wit

rawn

rom t

e mar

Adep

n iso-osmolar, biode

radable,

lucose pol

mer solution (Adept) contain

4% icodextrin recentl

became available for adhesion prevention in

intraabdominal sur

. Icodextrin is a substrate for am

lase, which is widel

distributed throu

hout the bod

but is not present in the human peritoneal

cavit

[15]. When

iven intraperitoneall

, icodextrin is lar

retained within

the peritoneal cavit

; absorption of the pol

mer occurs

raduall

via the l

phatic s

stem into the s

stemic circulation. Icodextrin is then readil

metabo

lized b

lase to oli

osaccharides, which are cleared b

further metabolism

lucose. The intraperitoneal residence time for a 4% icodextrin solution in

humans was shown to be at least 72–96 hours, in com

arison with saline-based

solutions. The ﬂ

uid dynamics of 4% icodextrin show that a volume placed into

the peritoneal cavit

after sur

would be present durin

the time of

maximum risk of adhesion formation, up to 3–5 da

s postsur

reclinical studies with 4

icodextrin in the rabbit double-uterine-horn

model demonstrated that in addition to signiﬁ

cant beneﬁ

ts following postop-

erative instillation, de novo formation of adhesions was signiﬁ

cantly reduced

frequent intraoperative irri

ation [15]. Adept treatment did not exacerbate

the course of induced bacterial peritonitis in rats, supportin

the use of 4%

icodextrin solution in both

necolo

ical and

eneral abdominal sur

. The

reduction of adhesion formation demonstrated in

reclinical studies encom-

passed not onl

the incidence but also the extent and severit

of adhesions.

The results of Adept reducing adhesions in animal models were conﬁ

extended in a pilot stud

of patients under

oin

laparoscopic

necolo

ical

n a pi

ot c

inica

stu

, postsur

ica

insti

ation o

ept (1 L) was eva

ated in a controlled, prospective, assessor-blinded stud

in female patients

under

oin

laparoscopic adnexal sur

with a follow-up laparoscop

. Adept

or lactated Rin

er’s solution (control) was used as an intraperitoneal irri

atin

olution at least ever

30 minutes durin

the sur

ical procedure [16]. Patients

who received Adept had fewer adhesions at second-look laparoscop

4–6

wee

ater (Fi

ure 6.4). Furt

er, patients wit

east 1 a

esion at t

e time

of surgery had a signiﬁ

cant re

uction in a

esions. T

e resu

ts o

is pi

study await conﬁ

rmation in a large pivotal study.

https://t.me/med1917

8 G.S. diZere

a and M. Korell

None Minimal Severe

% of Patients

Interceed

Intergel

gure 6.5

Results are shown

or patients undergoing myomectomy who received either

overing o

the uterine sur

ace with Interceed or instillation o

Intergel Adhesion Prevention

olution (300 mL) into the pelvis at the end o

surgery. About hal

the patients in both groups

ad no adhesions at

ollow-up laparoscopy, while only minimal adhesions were

ound in most

the other patients. Both devices were e

ective at reducing adhesions a

ter laparoscopic

yomectomy

(

Lactate

Rin

esis So

ution (

= 19) Adept (

= 23)

.8.8

-2

9.9.9.9.

-1

-2-2-2

-2

-2-2-2

mAF

everit

Inci

enc

% Chan

Severity

ncidence

Improved

rse

–

40 –30 –20 –10 0 10 20 30

gure 6.4. Results are shown

or patients who underwent laparoscopic adhesiolysis who

eceived 1 liter o

either Adept (

23) or

actate

Ringer’s so

ution (

19) at the end o

urgery. All patients underwent rinsing o

the pelvic cavity with 100 mL o

the respective test

ution every 30 minutes t

roug

out t

e surgica

proce

ure. Patients w

o receive

ept

an improvement in t

eir overa

omina

-pe

vic a

esion

en as measure

y t

AFS score determined at 23 di

erent anatomical sites, as well as in the incidence, extent,

nd severity o

adhesions compared to the patients who received lactated Ringer’s solution

ntergel Compar

son to Interceed

Korell compared the efﬁ

cacy of Intergel to that of Interceed in the reduc-

ion of adhesions followin

laparoscopic m

omectom

[17]. Women of repro-

uctive a

e (

81) were randomized to treatment with an adhesion

revention

https://t.me/med1917

Recent A

nces in A

hesi

n Preventi

evice

owin

aparoscopic m

omectom

, a proce

ure reporte

e asso

ciate

wit

up to 90% inci

ence o

severe a

esions [18]. Fo

owin

e use o

esion

revention

evices, a

out

atients were a

esion

ree, w

most o

e ot

ers

y minima

esions (Figure 6.5)

erspective

e a

esion prevention

arriers are sa

e an

ective in a

uman

inica

tria

s, t

eir use

oes not e

iminate a

esions in a

patients. Many

investigators are incorporating a

esion prevention

arriers into t

eir routine

clinical practice and achieving good results, even in difﬁ

cult clinical settings.

As a result of multiple demonstrations of barrier efﬁ

cacy, adhesion prevention

adjuvants have received widespread acceptance. Efﬁ

cacy of the barriers is

imite

to surgica

situations w

ere t

e area in question can

e comp

ete

covere

. T

e insti

ates Interge

ept, w

provi

e genera

ize

pe ritonea

coverage, can

e easi

y a

ministere

via eit

aparoscopy or

aparotomy.

ate no treatment

as proven uni

orm

y e

ective in preventing post

operative a

esion

ormation. Surgica

tec

niques t

imit tissue isc

emia,

as we

as a

sor

e, nonreactive mec

anica

arriers, provi

e c

inica

ene-

ﬁ

ts to patients today. Ongoing evaluations of drugs that modify the local

inﬂ

ammatory response and agents that reduce ﬁ

rin

eposition

ivere

irect

y into t

e peritonea

cavity s

ow promise

imiting a

esions

omorrow.

erences

1. Canis M, Botc

oris

i R, Tam

iurro S, et a

. A

esion prevention in t

e sur

ica

reatment o

vic en

ometriosis. G

naeco

osc

2001;10:99–106.

2. Tu

i T. Intro

uction-prevention o

esion

ormation: t

e journey continues.

um Repro

ate. 2001;7:545–546

3. A

-Musawi D, T

son JN. A

esion

revention: state o

e art.

ynaeco

osc.

2001;10

123

–

130

4. Luciano AA. Laparoscopic adhesiolysis.

ef Gynecol Obstet. Ex

erts Conference

ichy IFFFS; 1995:119–125

5. diZerega GS, Campeau JD. Peritoneal repair and post-surgical adhesion. H

rod.

001;7:547–555

6. Wiseman DM, Trout JR, Diamond MP. The rates of adhesion development and the

eff

ects o

sta

utions on a

esion

eve

opment in pe

vic sur

Fertil

teri

1998

–7

7. Shear L, Swartz C, Shinaberger J, et al. Kinetics of peritoneal ﬂ

sorption in

t man.

Eng

J Me

1965

;

272:123–127.

https://t.me/med1917

0 G.S. diZere

a and M. Korell

8. Haret R, Magos A. Laparoscopically instilled ﬂ

uid: the rate of absorption and the

effects on patient discomfort and ﬂ

ance.

neco

osc. 1996;5:287–291.

iZere

a GS. Peritoneum, peritonea

, an

esion

ormation. In:

iZere

. Peritonea

Surger

. New Yor

: Springer Ver

ag; 2000:3–37.

10. Jo

ns JB, Ro

gers KE, Dona

ue WD, et a

. Re

uction o

esion

ormation

ostoperative a

ministration o

ionica

y cross-

uronic aci

. Ferti

Steri

1997

8:37–42

11. Thornton MH, Johns DB, Campeau JD, et al. Clinical evaluation of 0.5% ferric hyal-

ronate adhesion prevention

el for the reduction of adhesions followin

peritoneal

avit

sur

; open label pilot stud

. Hum Re

rod.

998;13:1480–1485.

12. Johns DB, Ke

port GM, Hoehler F, et al. Prevention Stud

Group. Reduction of

ostsur

ical adhesions with Inter

el adhesion prevention solution: a multicenter

study of safety and efﬁ

cacy after conservative gynecologic surgery.

erti

teri

001;76:595–604.

13. Lun

P, van Ge

rop H, Tronsta

SE, et a

. Re

uction o

post-surgica

esions

erric

uronate ge

: a European stu

um Repro

. 2001

;

:1982–1988

14. T

ornton MH. Re

uction o

esion

ormation wit

Gynecare Interge

esion

revention solution following laparoscopic gynecologic surgery. A

ssociation

ynecol Laparoscopit

2002

;

55.

15. Verco SJS, Peers EM, Brown CB, et al. Development of a novel

lucose pol

mer

solution (Icodextrin) for adhesion prevention: pre-clinical studies. Hum Re

rod.

000;15:1764–1772

16.

iZere

a GS, Verco SJS, Youn

P, et a

. A ran

omize

, contro

ot stu

safety and efﬁ

cacy of 4% icodextrin solution (Adept®) in the reduction of adhesions

owing

aparoscopic gynaeco

ogica

surgery. Hum Repro

2002;1

;1031

–

1038.

17. Kore

M. A

tue

e A

aesionsprop

axe in

er operativen Gynae

ogie. Der

aekologe. 2002 (in

ress)

18. Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum

rod U

date. 2001;7:5

7–57

https://t.me/med1917

7. What to Do When the O

eration

irginia A. Becket

Derek J. Tuffnel

If you seek advice on to how to get out of a difﬁ

cult situation, a wise respondent

will tell you not to start from where you ﬁ

nd yourself. This is particularly the

case for operative complications. If you consider how to get out of the problem

only once it has occurred, you are going to be faced with signiﬁ

cant difﬁ

culties.

ther chapters deal with the issue of consent, but issues such as trainin

, staff-

ng, and equipment availability all should be considered. However, even with

hese preparations, all surgeons will have complications. Those who do not fall

nto the three Ps: perfect

—

there aren’t any surgeons we know of in this group;

inocchio

—those who are economical with the truth or at best forgetful; and

ermanently on holida

It is against this background that we consider pre

entable harm and how it should be addressed

incent et al. report in their retrospective study that 5% of patients admit

ed to 2 lar

e hospitals in Greater London suffered preventable harm [1]. A

ubsequent analysis of the causes of errors in clinical practice by the same

roup [2] suggested that less than 20% of preventable adverse events were

irectl

related to sur

ical operations or invasive procedures. However, it is

likel

that we will all be involved, either directl

or indirectl

, in an

verse inci

ent at some point in our careers. T

e process o

ris

management

ims to proactive

y i

enti

y, assess, an

treat ris

ing to t

e prevention

oreseea

e a

verse events [3]. As a consequence o

proactive ris

manage

ent, uninten

arm to patients is re

uce

patient sa

ety an

care

re improved. The Department of Health document An Organisation with a

emory recommen

a re

uction o

25% in t

e num

er o

cases o

neg

igent

arm in o

stetrics an

gyneco

ogy

y 2005 [4]. It is not yet c

ear w

er t

oal has been achieved. A reactive approach to adverse events would not

chieve this type of target. However, as part of a systematic approach to risk

ssessment, engaging in proactive risk management activity, in addition to the

reactive process of incident management, will enable the identiﬁ

cation of the

any t

ings t

at cou

go wrong [5]. Root cause ana

ysis is a structure

nvestigation that aims to establish the underlying cause of serious incidents.

n many cases, the root cause of an adverse event lies with the management

organizations t

at support t

ivery o

care an

not wit

ivi

care pro

essiona

s. T

e Nationa

Patient Sa

ety Agency was set up to run

nationa

system o

reporting a

verse events an

aime

to re

uce

uture

arm

o patients

y i

enti

ying an

ressing

unctiona

systems. T

is process

https://t.me/med1917

2 V

Beckett

.J.

ffnell

ncoura

es a s

t awa

rom a “

ame” cu

ture to a “

ust” cu

ture. B

encour-

esprea

reportin

near misses an

critica

inci

ents, we can use

e ris

mana

ement an

patient sa

process to i

enti

areas

or c

so to

or improvement. We s

now

e wor

ing in environ

ents wit

ust s

stems in p

ace to

e t

e reportin

ana

sis o

verse events as part o

inica

overnance. I

not, it is in our interests to

eff

ect

oca

organizationa

ange.

reoperat

ve Car

n man

cases, intraoperative adverse events can be limited or prevented

careful preoperative preparation of the patient. A root cause anal

sis ma

ocus on the followin

points

. Consent should be informed

with all reasonable risks discussed with

he patient b

a staff member who is adequatel

trained to do so.

. The correct e

ment should be antici

ated and available. Theater

sta

mili

r wi

h i

use.

3. The sur

eon should be competent to carr

out the planned

rocedure

. Appropriate operative assistance and nursin

staff should be

5. National Conﬁ

dential Enquiry into Perioperative Deaths (CEPOD)

uidelines, particularl

with respect to the preoperative resusci-

ation of patients and the timin

of procedures, should be ob

served

[

the Procedure

ollowin

an adverse event, the optimal response would demonstrate that

ersonnel reco

nized the event appropriatel

and acted in a timel

and

ithin their sphere of competence, callin

for assistance where necessar

mmediate steps should be taken to investi

ate the cause and consequences of

he event where a

riate

o demonstrate such an “o

timal res

onse,” clear and contem

oraneous

otes are vital. Durin

lon

procedures, it ma

be useful to ask one of the

heater staff to record the timin

of events to improve accurac

. It is particu

arl

important to document who called for help and at what time, and the

ime that help arrived, while noting any reason for delays. Detail the avail-

ability of signiﬁ

cant individuals and e

ment. Provide a clear descri

tion o

ow the complication was reco

nized and remedied. Ensure that handwritin

s le

ible and that each entr

has a date, time, and si

nature, with the patient’s

etails on each sheet of

er.

https://t.me/med1917

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