Subtotal versus total abdominal hysterectomy

54 Pages·2015·8.82 MB·English

Research
ajog.org
GYNECOLOGY
Subtotal versus total abdominal hysterectomy:
randomized clinical trial with 14-year
questionnaire follow-up
LeaLairdAndersen,MD;BentOttesen,MD,DMSc;LarsMikaelAllingMøller,MD,PhD;
ChristianGluud,MD,DMSc;AnnTabor,MD,DMSc;VibekeZobbe,MD;EliseHoffmann,MD;
HelgaMargretheGimbel,MD,DMSc;fortheDanishHysterectomyTrialGroup
OBJECTIVE: The objective of the study was to compare long-term (Short Form-36 questionnaire), hospital contacts, and vaginal
results of subtotal vs total abdominal hysterectomy for benign uter- bleeding.
inediseases14yearsafterhysterectomy,withurinaryincontinenceas
RESULTS: The questionnaire was answered by 197 of 304 women
theprimaryoutcomemeasure.
(64.8%)(subtotalhysterectomy[n¼97][63.4%];totalhysterectomy
STUDYDESIGN:This was a long-term follow-up of a multicenter, [n¼100][66.2%]).Meanfollow-uptimewas14yearsandmeanage
randomized clinical trial without blinding. Eleven gynecological atfollow-upwas60.1years.Aftersubtotalabdominalhysterectomy,
departments in Denmark contributed participants to the trial. 32of97women(33%)complainedofurinaryincontinencecompared
Women referred for benign uterine diseases who did not have with20of100women(20%)aftertotalabdominalhysterectomy14
contraindications to subtotal abdominal hysterectomy were yearsafterhysterectomy(relativerisk,1.67;95%confidenceinterval,
randomized to subtotal (n ¼ 161) vs total (n ¼ 158) abdominal 1.02e2.70; P ¼ .035). After a multiple imputation analysis, this
hysterectomy. All women enrolled in the trial from 1996 to differencedisappeared (relative risk, 1.36; 95% confidence interval,
2000 who were still alive and living in Denmark (n ¼ 304) 0.86e2.13; P ¼ .19). No differences were seen in any of the sec-
were invited to answer the validated questionnaire used in prior ondaryoutcomes.
1 and 5 year follow-ups. Hospital contacts possibly related to
CONCLUSION:Subtotal abdominal hysterectomy was not superior to
hysterectomy from 5 to 14 years postoperatively were regis-
totalabdominalhysterectomyonanyoutcomes.Morewomenseemto
tered from discharge summaries from all public hospitals in
havesubjectiveurinaryincontinence14yearsaftersubtotalabdominal
Denmark. The results were analyzed as intention to treat and
hysterectomy. This result was not confirmed by multiple imputation
per protocol. Possible bias caused by missing data was
analysisandshouldbeinterpretedcautiously.
handled by multiple imputation. The primary outcome
was urinary incontinence; the secondary outcomes were pelvic Keywords:hysterectomy,long-termfollow-up,pelvicorganprolapse,
organ prolapse, constipation, pain, sexuality, quality of life qualityoflife,urinaryincontinence
Citethisarticleas:AndersenLL,OttesenB,AllingMøllerLM,etal.Subtotalversustotalabdominalhysterectomy:randomizedclinicaltrialwith14-yearquestionnaire
follow-up.AmJObstetGynecol2015;212:758.e1-54.
A
pproximately 4500 benign hyster-
FromtheDepartmentofObstetricsandGynecology,NykøbingFalsterHospital,NykøbingFalsterin
ectomies are performed yearly in
associationwiththeUniversityofSouthernDenmark(DrsAndersenandGimbel);JulianeMarie
Denmark.1 Although the use of the less
Center(DrOttesen),DepartmentofObstetricsandGynecology(DrsZobbeandTabor),and
CopenhagenTrialUnit,CenterforClinicalInterventionResearch(DrGluud),Rigshospitalet, invasivelaparoscopicmodeofhysterectomy
CopenhagenUniversityHospital,Copenhagen;andDepartmentofObstetricsandGynecology, is rising, 32% of Danish hysterectomies
RoskildeHospital,Roskilde(DrsAllingMøllerandHoffmann),Denmark. in2012wereabdominal,2andmorethan
ReceivedSept.9,2014;revisedNov.14,2014;acceptedDec.17,2014. 50% of hysterectomies in the United
Thislong-termfollow-upstudywassupportedbytheresearchfoundationofRegionSjælland, Stateswereabdominalin2010.3
UniversityofSouthernDenmark,andtheDepartmentofGynecology,NykøbingFalsterHospital, Of abdominal hysterectomies, 10%
Rigshospitalet(CopenhagenUniversityHospital),andRoskildeHospital,Denmark.
were subtotal, and of laparoscopic hys-
B.O.andH.M.G.aremembersoftheboardoftheDanishHysterectomyandHysteroscopy terectomies, 20% were subtotal in
Database.Theotherauthorsreportnoconflictofinterest. Denmarkin2011.1Insomehospitalsin
Presentedinoralformatatthe39thbiannualmeetingoftheNordicFederationofSocietiesof
Germany, subtotal laparoscopic hyster-
ObstetricsandGynecology,Stockholm,Sweden,June10-12,2014,andasaposteratthe7th
ectomyisthestandardandaccountsfor
annualcongressofLeadingLightsinUrogynecology,EuropeanUrogynecologicalAssociation,
Athens,Greece,Oct.2-4,2014. more than 80% of laparoscopic hyster-
ectomies.4 The background for prefer-
Correspondingauthor:L.L.Andersen,[email protected]
ring subtotal hysterectomy is that it is
0002-9378/$36.00 (cid:2) ª2015ElsevierInc.Allrightsreserved. (cid:2) http://dx.doi.org/10.1016/j.ajog.2014.12.039
simpler and quicker and may result in
758.e1 AmericanJournalofObstetrics&Gynecology JUNE2015
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fewer complications.5 However, mor- The sample size of the original trial women who reported UI at any time
cellation is part of this mode of hyster- was calculated based on an assumed since hysterectomy including prior
ectomy, and because leiomyosarcomas prevalence of the primary outcome, follow-ups.14,15
are sometimes mistaken for fibromas, UI, 1 year after TAH of approximately Secondary outcomes were hospital
morcellationisnolongerrecommended 23%.21,22 With a power of 0.80, a contacts, pelvic organ prolapse (POP),
by the Food and Drug Administration6; type I error of 5%, and a 15% abso- pelvic pain, satisfaction with sex life,
consequently, one may assume, in the lute difference in UI between the constipation, quality of life (QoL), and
future, large uteri will more often be surgical groups, 160 participants had vaginal bleeding after SAH. All out-
removedbyabdominalhysterectomy. to be included in each intervention comes,exceptQoL,weredichotomized,
Studiesinthe1980s7-9suggestedthat group.14 and the SAH and TAH groups were
subtotalabdominalhysterectomy(SAH) Results from 1 year of follow-up14 comparedusingac2test.Analyseswere
was superior to total abdominal hyster- showed that significantly more women conductedasintentiontotreataswellas
ectomy (TAH) regarding sexual func- intheSAHgroupwereurinaryinconti- per protocolexcluding participantsthat
tion.Thisfindingwasnotreproducedin nent compared with the TAH group. A didnotreceivetheallocatedintervention
randomized clinical trials (RCTs).10-12 decrease in UI after hysterectomy was (Figure 1). As in prior follow-ups,14,15
The risk of cervical cancer in the seen in both surgical groups. The sec- the conclusions are based on the
remaining cervix is another important ondaryoutcomespostoperativecompli- intention-to-treatanalyses.Additionally,
issue. Nevertheless, if a Papanicolaou cations, quality of life (Short Form-36 satisfaction with sex life was analyzed
smearisnormalpriortosurgeryandthe [SF-36]), constipation, pelvic organ separately for those stating they had a
woman continues to participate in cer- prolapse, satisfaction with sexual life, partnerandthosewhodidnot.
vicalcancerscreening,theriskofcervical and pelvic pain did not show any dif- QoLwasassessedbythevalidatedSF-
cancerisonlyapproximately0.03%.14,15 ferencebetweensurgicalgroups.Neither 36 questionnaire25 included in our
Three RCTs comparable with our didthefurtheranalysesoflowerurinary questionnaire (Supplemental Material).
Danish trial15,16 comparing SAH with tract symptoms23 and sexuality.13 At 1 SF-36wasscoredaccordingtothespec-
TAH16-18 have performed long-term year, 20% of the SAH group still expe- ifications by Quality Metric using the
follow-up and found no significant dif- rienced vaginal bleeding. At 5 years,15 official scoring software. For each
ferences between SAH and TAH on the significant difference between SAH participant a physical component score
clinical outcomes. Few data on long- and TAH regarding UIwas reproduced. (PCS) and a mental component score
term outcomes after subtotal vs total Thenumberofincontinentwomenwas (MCS)werecalculated.Thesescoresare
laparoscopic hysterectomy are avail- higherthanat1year.IntheSAHgroup, validatedandanormsbasedmeanof50
able.19 Although open abdominal and 11%stillexperiencedvaginalbleeding. is interpreted as average QoL. Means
laparoscopic surgery differ in many Allparticipantsstillaliveandlivingin werecomparedbetweensurgicalgroups
ways, the most recent Cochrane sys- Denmark in September 2012 werecon- using the Wilcoxon rank sum test
tematic review20 on the topic included tacted by letter, and it contained the because the scores were not normally
both methods and stated that therewas validated questionnaire24 (Appendix; distributed.
no evidenceto supportthe shifttoward Supplemental Material) used in prior Some women did not answer all
subtotal hysterectomy seen in laparos- follow-ups.14,15 The questionnaire questionsresultingindifferenttotalsfor
copy.Theauthorsofthereviewconclude assessed primary and secondary out- eachanalysis.Thenumberineachgroup
thatmorelong-termfollow-upisneeded comes(presentedinthefollowingtext). for the particular analysis is stated in
because urogenital problems mayoccur Reminders were sent 2 and 7 months Table 1. To account for possible bias
years after surgery, especially in post- later to nonresponders. Participants caused by missing data because of the
menopausalwomen.20 were encouraged to return the ques- loss to follow-up and incomplete ques-
We aimed to compare 14-year out- tionnaire unanswered if they did not tionnaires, multiple imputation (MI)
comes after SAH vs TAH in women wish to participate, thus avoiding re- wascarriedoutusingtheFCSmethodin
included in a randomized clinical trial minders.Ageatfollow-upandfollow-up SAS (version 9.3; SAS Institute, Cary,
for benign uterine diseases.14,15 The timewascalculatedwithJanuary2013as NC) using the PROC MI and MIANA-
primary outcome is urinary inconti- thecutoffpoint. LYZE functions. The 14-year outcomes
nence(UI)14yearsafterhysterectomy. The primary outcome, UI, was imputed were UI, pelvic pain, POP,
defined as a subjective complaint of satisfaction with sex life, QoL, and
MATERIALS AND METHODS involuntary loss of urine often or constipation.
In1996e2000,319womenfrom11gy- always (question 35 in the question- Thefollowingvariableswereincluded
necological departments in Denmark naire). Because this result could re- in the imputation model because they
were randomized to SAH vs TAH.14 flect a difference in treatment-seeking were associated with (P < .1) one or
Details about eligibility criteria, con- behavior between surgical groups moreoftheoutcomesinthemultivariate
sent,inclusion,randomization,andsur- rather than in the occurrence of UI, logisticregression:baselinevariablesin-
gical procedures have been published.14 we also analyzed the number of cluded type of surgery, number of
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results.27TheQoLscoreswerenotnor-
FIGURE1
mally distributed, and despite using the
Flowchartofparticipants
transformationsofinverse,log,squared,
gamma,exponential, boxcox,andbeta,
wecouldnotapproximatethenormality.
Weenteredtheuntransformedscoresin
the MI model and analyzed them using
the Wilcoxon rank sum test. Because a
normal distribution is assumed in MI,
this could potentially skew other out-
comes.However,werantheMIwithand
without QoL included, and it had no
impactonotheroutcomes.
Hospital contacts were registered for
allrandomizedwomenbylookingupall
dischargesummariesfromDanishpub-
lichospitalsfrom5yearspostoperatively
until July 2013 in the central registryof
discharge summaries. Any hospital
contact regarding abdominal, gyneco-
logical,urological(includingUI),plastic
surgical, or dermatological complaints
werescrutinized.Ifthecontactmightbe
relatedtothepriorhysterectomy,itwas
registered. Hospital contacts from the
time of surgery until 5 years post-
operatively have been published else-
where.14,15 Hospital contacts were
divided into the following categories:
recurrent urinary tract infection
(including pyelonephritis), pain, UI,
POP, cervical problems (bleeding or
dysplasia), other urogenital, skin prob-
lems/hernias,andothers.
All data were handled and analyzed
using SASjmp version 10 statistical
Thefigureshowsparticipantsateachstageofthetrialfromrandomizationthroughallfollow-upsand software (SAS Institute) except for MI,
reasonsfordropouts. whichwascarriedoutinSASversion9.3
(SASInstitute).
SAH,subtotalabdominalhysterectomy;TAH,totalabdominalhysterectomy.
Andersen.SAHvsTAH,RCTwith14yearfollow-up.AmJObstetGynecol2015. Theoriginaltrialaswellasthisfollow-
up was accepted by the regional ethics
committee journal number, SJ-268, as
well as the Danish Data Protection
deliveries,largestbabygreaterthan4000 precision in the analyses. The MI Agencyjournalnumber2012-41-0286.
g, smoking more than 5 cigarettes per method assumes that missingness is
day, alcohol consumption greater than missing at random, meaning that RESULTS
14 units per week (1 unit ¼ 12 g of missing data are related to other We contacted 304 women (95.3%)
alcohol), UI, pain, and constipation. observed variables but not to unob- (SAH: 153; TAH: 151); 10 (3.1%) had
Follow-up variables included were as served variables or to the missing died,fromcausesunrelatedtohysterec-
follows: UI, pelvic pain, POP, con- items.26 The imputed datasets were tomy, and 5 (1.6%) had left Denmark.
stipation, satisfaction with sex life at 1 analyzed by a c2 test, and the pooled Two hundred forty-nine women (82%)
and 5 years, and physical (PCS) and analyses were carried out using the returnedthequestionnaire;however,52
mental(MCS)QoLscoresat1year. MIANALYZE function (SAS Institute). (17.1%) returned it blank stating that
One hundred imputed datasets were Relative risks were logarithmically theydid not wish to participate. Atotal
created using a maximum of 100 itera- transformed before pooling to comply of 197 (64.8%) answered the question-
tions. This was chosen to obtain high with Rubin’s rules for pooling imputed naire(Figure1).
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TABLE1
Primaryandsecondaryoutcomemeasuresat14yearfollow-upintention-to-treat
Observeddata Multipleimputation
Outcome
(n[SAH/TAH) SAH TAH RR 95%CI Pvalue RR 95%CI Pvalue
UI,%(n¼96/100) 32(33.3) 20(20) 1.67 1.02e2.70 .035a 1.36 0.86e2.13 .19
Constipation,% 14(14.4) 7(7) 2.06 0.87e4.89 .091 1.77 0.83e3.77 .14
(n¼97/100)
Pelvicorganprolapse, 12(12.9) 11(11.3) 1.14 0.53e2.45 .74 0.97 0.50e1.86 .92
%(n¼ 93/97)
Satisfiedwith 48(64) 53(67.9) 0.94 0.75e1.18 .61 1.09 0.76e1.58 .64
sexuallife,%
(n¼75/78)
Pelvicpain,% 14(14.6) 10(10) 1.46 0.68e3.12 .33 1.33 0.69e2.55 .40
(n¼96/100)
Vaginalbleeding,% 0
(SAHonly,n¼97)
QoLb Mean(95%CI) Mean(95%CI)
SAH TAH
PCSmean(95%CI) 50.4(48.5e52.4) 51.3(49.4e53.2) .54 50.05(48.5e51.6) 50.9(49.1e52.8) .67
MCSmean(95%CI) 54.8(52.9e56.7) 53.2(51.4e55.1) .39 54.4(52.5e56.1) 52.2(50.7e54.2) .87
CI,confidenceinterval;MCS,mentalcomponentscore;PCS,physicalcomponentscore;QoL,qualityoflife;RR,relativerisk;SAH,subtotalabdominalhysterectomy;TAH,totalabdominalhys-
terectomy;UI,urinaryincontinence.
aStatisticallysignificant;bWilcoxonranksumtest.
Andersen.SAHvsTAH,RCTwith14yearfollow-up.AmJObstetGynecol2015.
The number of participants in the Analysis of multiple imputed data difference in satisfaction with sex life
groupswassimilar:97of153(63.4%)in showed no significant differences be- betweenSAHandTAHoverall(Table1)
theSAHgroupand 100of151(66.2%) tween surgical groups regarding UI orwhensubdividedaccordingtopartner
intheTAHgroup.Characteristicsofthe (P¼.19)(Table1). status (data not shown). The other sec-
participants and nonparticipants in this Neither the physical (PCS) nor the ondary outcomes are shown in Table 1.
follow-up (Table 2) did not differ ac- mental (MCS) score of the SF-36 QoL None of them showed significant dif-
cording to baseline variables from time questionnaire differed between the sur- ferences between surgical groups in the
of surgery except that fewer of the par- gical groups, and the means were analysis of observed data or in multiple
ticipants were smokers at the time of consistentwiththeexpectedmeanof50 imputation.
surgery and more participants had an (Table 1). None of the participants Hospital contacts from 5 to 14 years
alcohol consumption greater than 14 experiencedvaginalbleedingat14years. afterhysterectomyareshowninFigure2.
units per week at time of surgery than Twenty-one women (11.5%) stated Therewasnosignificantdifferenceinthe
the nonparticipants. The 2 surgical they did not have a partner. Of these, 9 totalnumberofhospitalcontacts(SAH,
groups of responders were comparable (42.9%) stated that they did not know 29[17.7%]vsTAH,18[11.3%];relative
(Table 2). Mean age at follow-up was whethertheyweresatisfiedwiththeirsex risk, 1.57; 95% confidence interval,
60.1years;meanfollow-uptimewas14.1 life. Six (28.6%) stated they were satis- 0.91e2.71;P¼.10).
years. fiedand6(28.6%)statedtheywerenot.
MorewomenintheSAHgroup(32of Among those with a partner (n ¼ 162, COMMENT
97,33.3%)thanintheTAHgroup(20of 88.5%), 22 (13.6%) did not know On observed data, we found that more
100, 20%) reported UI often or always whethertheyweresatisfiedwiththeirsex women had UI after SAH than after
(P¼.035)(Table1).Thedifferencewas life, 94 (58%) were satisfied, and 46 TAH 14 years after surgery. This is
also significant in the per-protocol (28.4%)werenot.Thosewhostatedthey consistent with prior results from our
analysis (P ¼ .024) (Table 3). Table 3 didnotknowwhethertheyweresatisfied trial.14,15 At14years, thepercentageof
also shows the other analyses of UI as were excluded from the analysis of UI in the TAH group has reached
described in the Materials and Methods satisfactionwithsexlifeinthe2surgical approximately the prehysterectomy
section. groups (Table 1). There was no level,whereasthepercentageintheSAH
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TABLE2
Characteristicsforrespondersandnonrespondersaswellastherespondersdividedintosurgicalgroups
Participants Nonparticipants SAHparticipants TAHparticipants
Characteristic (n[197) (n[122) Pvalue (n[97) (n[100)
Age,y(SD) 60.1(5.8) 60.5(6.6) .58 60.7(5.9) 59.6(5.6)
Follow-uptime,y(range) 14.1(12e16) 14.04(12e16) .77 14.2(12e16) 14.03(12e16)
Parity(range) 1.8(0e5) 1.74(0e5) .58 1.85(0e5) 1.76(0e4)
BMI,kg/m2(SD)a 26.1(6.7) 25.5(4.6) .38 26.45(7.1) 25.71(6.3)
Indicationforhysterectomy,%
Fibroids 115(58.4) 70(57.4) .86 58(59.8) 57(57.0)
Abnormaluterinebleeding 63(31.9) 42(34.7) .59 29(29.9) 34(33.6)
Dysmenorrhea 8(4.1) 4(3.31) .74 3(3.1) 5(4.9)
Pelvicpain 9(4.6) 4(3.31) .58 6(6.2) 3(2.9)
Endometriosis 0 1(0.83) .16 0 0
Other 2(1.02) 1(0.83) .87 1(1.03) 1(0.99)
Typeofsurgery,%
SAH 97(49.2) 64(52.5) .58
TAH 100(50.8) 58(47.5) .58
Smoking>5cigarettes 46(23.4) 57(46.7) <.0001 18(18.6) 28(28.0)
perday,%b
Alcohol>14units 22(11.2) 6(4.9) .047 13(13.4) 9(9.0)
perweek,%b,c
Chronicdisease,%d 97(49.2) 25(29.4) .0018 49(50.5) 48(48.5)
PreoperativeUI,% 48(25.0%)(n¼192) 20(17.4%)(n¼115) .110 26(27.7%)(n¼94) 22(22.2%)(n¼99)
BMI,bodymassindex;SAH,subtotalabdominalhysterectomy;TAH,totalabdominalhysterectomy;UI,urinaryincontinence.
aBMIatfollow-upforparticipantsbutbaselinefornonparticipants;bAttimeofsurgery;cAunitofalcohol,inDenmark,isdefinedas12gofalcohol,whichistheapproximatecontentofanormal
beeroraglassofwine;dAt14yearfollow-upforparticipantsandat1yearfornonparticipants.
Andersen.SAHvsTAH,RCTwith14yearfollow-up.AmJObstetGynecol2015.
groupisnowhigher.14However,theMI baseline data do not suggest systematic difference regarding UI or any other
analysis did not show a significant dif- differences. The internal validity could outcomes. This might reflect that there
ference.Nosignificantdifferenceswere be compromised if an imbalance was truly is no difference, and our observed
found between SAH and TAH on the seeninrespondersbetweenintervention finding may be caused by attrition bias.
secondaryoutcomes. groups.However,therespondersinthe2 Alternatively, the uncertainty incorpo-
Thestrengthsofthepresentresultsare surgical groups are comparable accord- ratedinMI(withinimputationvariance
that they represent the largest random- ingtobaselinecharacteristics. and between imputation variance)26 in-
ized clinical trial on the topic and have None of the reasons given for not creases with the percentage of missing
the longest follow-up time. The Danish participating were related to the hyster- dataandyieldswiderconfidenceintervals
social security number enabled us to ectomymethod.Explanationsofourlow leadingtononsignificantresults.Athird
locate all participants and look up hos- response could be the loss of interest explanationofthedifferencebetweenour
pitalcontactsforeveryone. becauseofthelongfollow-up,olderage, observed and MI results could be an
Onelimitationofthisfollow-upisthe or medical conditions making it over- unknown confounding factor related to
lowresponse,whichmightcompromise whelming to be asked to participate. In missingness as well as UI, meaning that
the external validity of the trial. Non- addition, according to the ethics com- ourassumptionofmissingatrandomis
responders might differ in a systematic mittee, we wereallowed to contact par- incorrect,and the dataare truly missing
wayfromresponders,meaningthatour ticipants by letter only. Contact by not at random. In this case, the MI
sampleatfollow-upislessrepresentative telephonewasallowedinearlierfollow- analysis is not valid.26 Our observed
of the population thanthe original trial ups14,15aswellasinacomparabletrial.16 findings correspond well with prior
sample.Otherthansmokingandalcohol We used MI to handle missing data. follow-ups of this trial with higher
consumptionatthetimeofsurgery,our This analysis showed no significant response proportions.14,15 The relative
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TABLE3 FIGURE2
Analysesofurinaryincontinence Hospitalcontactsfrom5to14
yearsafterhysterectomy
Urinaryincontinence
(n[SAH/TAH) SAH(%) TAH(%) RR 95%CI Pvalue
Questionnaireonly(n¼97/100) 32(33.3) 20(20) 1.67 1.02e2.70 .035a
Questionnaireorpriortreatment 34(35.4%) 23(23%) 1.54 0.98e2.41 .056
forUIaccordingtodischarge
summaries(n¼97/100)
Questionnaireatanytimepoint 67(41.6%) 49(31%) 1.34 1.0e1.80 .049a
(allparticipantsinRCT)
(n¼161/158)
Questionnaireatanytimepoint 45(46.9%) 31(31%) 1.51 1.05e2.17 .023a
(onlythosewhoanswered14year
follow-up)(n¼96/100)
Perprotocol(n¼84/88) 29(34.5) 17(19.3) 1.78 1.06e3.00 .024a Barchartofhospitalcontactspossiblyrelatedto
CI,confidenceinterval;RCT,randomizedcontrolledtrial;RR,relativerisk;SAH,subtotalabdominalhysterectomy;TAH,total thepriorhysterectomy.Contactsaredividedinto
abdominalhysterectomy;UI,urinaryincontinence. categoriesandareshownforeachhysterectomy
aStatisticallysignificant. groupseparately.
Andersen.SAHvsTAH,RCTwith14yearfollow-up.AmJObstetGynecol2015. UTI,urinarytractinfection.
Andersen.SAHvsTAH,RCTwith14yearfollow-up.AmJ
ObstetGynecol2015.
riskfoundinMIforUIisthesameasit etal18aresponseof82%(n¼151),and
wasinthe5yearfollow-up15;however,in Greer et al16 a response of 27.4% (n ¼
thatanalysisthevaluewasP¼.052,much 37).Ourresponseof64.8%(n¼197)is Likecomparable trials,16-18 we found
closer to a statistically significant result. comparablewiththese.Noneoftheother no difference in QoL between surgical
This could reflect the increased uncer- long-term follow-ups16-18 included MI groups.QoLscoresweresimilartoour1
taintybecauseofthehigherpercentageof orother waysofhandling missingdata, yearfollow-up.14QoLisimportantwhen
missingdataasexplainedabove. meaning thatpossible attritionbias was treating benign diseases, and a stable
Another limitation of the trial is the not elucidated in these trials. A meta- scoreafter14yearsisagoodoutcomefor
lackofblinding.Thishasbeendiscussed analysis including all long-term RCTs theparticipants.
inpriorfollow-ups.14,15 and taking attrition bias into account Upto14yearsafterhysterectomy,we
Long-term follow-up of SAH vs TAH wouldbeofgreatinterest. still saw hospital contacts possibly
hasbeencompletedin3otherRCTs.16-18 Ourtrialincludedwhitewomenonly, related to hysterectomy. We found a
The longest follow-up was 11.3 years,18 and therefore, our results cannot be nonsignificant tendency toward more
withameanageof57years.Thesetrials readily transferred to populations of hospital contactsin the SAH group. No
found no significant differences in the mixed ethnicity. The prevalence of UI other long-term follow-ups16-18 have
outcomes studied. Persson et al18 saw a differs between ethnic groups; stress UI lookedatthisoutcome.
tendency toward worse outcomes after is less common in women of African None of the women had vaginal
SAHthanafterTAHandconcludedthat descent.28,29 This could explain the dif- bleedingat14years.At5years,1511%of
this might have been significant if the ferencebetweenourresultsandthoseof the women in the SAH group experi-
study had sufficient power or longer Thakar et al17; their population was enced vaginal bleeding. Natural meno-
follow-up. Our trial is larger and has mixed and one third of the population pause is the main reason for the
longerfollow-up,andwefoundasignif- wasofAfricandescent. difference in results from 5 to 14 years.
icantdifferenceinUI.Wealsolookedat One theory to explain our finding of Only one woman had her cervix
thenumberofincontinentwomenatany more UI in the SAH group is that the removedsincelastfollow-up,andthisis
time point to see whether the difference methodofsuspensionofthevaginaused included in the cervical problems cate-
found at 14 years was a difference in in SAH and TAH might differ; no in- goryinFigure2.
occurrence of UI or a difference in structions regarding suspension were Other outcomes might be important
treatment-seekingbehaviorbetweensur- given to the surgeons. The suspension after laparoscopic hysterectomy such as
gical groups. This analysis also showed performed in TAH might yield more vaginal dehiscence in total laparoscopic
significantlymorewomenwithUIinthe supportthanthewoman’sownconnective hysterectomyandleiomyosarcomasand
SAHgroupthantheTAHgroup. tissue,sparedinSAH,whichmightleadto other complications to morcellation af-
The comparable trials also had stress UI in the SAH group. A further ter subtotal laparoscopic hysterectomy.
missing data. Thakar et al17 had a investigation of how suspension is per- RCTs with long-term follow-up are
response of 65% (n ¼ 181), Persson formedmightelucidatethis. needed to compare subtotal vs total
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laparoscopic hysterectomy to shed light designofthelong-termfollow-upwithL.L.A.and 13.Jacoby VL. Hysterectomy controversies:
on these outcomes unless the subtotal H.M.G. All of the authors critically revised the ovarian and cervical preservation. Clin Obstet
articleand approved thefinal manuscript. The Gynecol2014;57:95-105.
approach is stopped because of morcel-
DanishHysterectomyTrialGroupparticipatedin 14.Gimbel H, Zobbe V, Andersen BM,
lation issues.6Thepercentage ofhyster-
recruitingandrandomizingtheparticipants.The Filtenborg T, Gluud C, Tabor A. Randomised
ectomies performed abdominally has local ethics committees of the participating controlledtrialoftotal compared withsubtotal
been declining.1,2The recentdiscussion centers (Bornholm, Frederiksborg, Roskilde, hysterectomy with one-year follow up results.
ofmorcellation6couldmeanareturnto Storstrøms,andVestsjællandsCounties,journal BJOG2003;110:1088-98.
number1995-1-65)andtheDanishDataPro- 15.AndersenL,ZobbeV,OttesenB,GluudC,
abdominal hysterectomy for large uteri
tectionAgencyhadacceptedthedesignofthe Tabor A, Gimbel H. Five-year follow up of a
andanincreaseinvaginalhysterectomy
randomizedclinicaltrialbeforetherecruitmentof randomisedcontrolledtrialcomparingsubtotal
forsmalleruteri. patients as well as the current follow-up. The withtotalabdominalhysterectomy.BJOG2014
Inconclusion,onobserveddata,more regional ethics committee in Region Sjaelland [Epubaheadofprint].
women were urinary incontinent after acceptedthedesignofthelong-termfollow-up 16.Greer WJ, Richter HE, Wheeler TL, et al.
(journalnumberSJ-268). Long-term outcomes of the Total or Supra-
SAHcomparedwithTAH;however,this
cervical Hysterectomy (TOSH) Trial. Female
result must be interpreted cautiously
PelvicMedReconstrSurg2010;16:49-57.
because of a high loss to follow-up. A 17.Thakar R, Ayers S, Srivastava R,
metaanalysisofalllong-termfollow-ups ManyondaI. Removingthecervixat hysterec-
REFERENCES
might elucidate this topic. The shift to- tomy: an unnecessary intervention? Obstet
1.DanskHysterektomiDatabase.Danishhys- Gynecol2008;112:1262-9.
ward subtotal hysterectomy in laparos-
terectomydatabaseyearlyreport,2011.Dansk 18.PerssonP,BrynhildsenJ,KjolhedeP.Pelvic
copy might not be of long-term benefit
HysterektomiDatabase;Oct.1,2012. organprolapseaftersubtotalandtotalhyster-
to the patients, if the results from 2.Danish Hysterectomy and Hysteroscopy ectomy: a long-term follow-up of an open
abdominalhysterectomycanbedirectly Database.Nationalyearlyreport,2012.2013. randomisedcontrolledmulticentrestudy.BJOG
transferredtolaparoscopy. - 3.WrightJD,HerzogTJ,TsuiJ,etal.Nation- 2013;120:1556-65.
wide trends in the performance of inpatient 19.Nesbitt-Hawes EM, Maley PE, Won HR,
hysterectomy in the United States. Obstet etal.Laparoscopicsubtotalhysterectomy:evi-
ACKNOWLEDGMENTS
Gynecol2013;122:233-41. denceandtechniques.JMinimInvasiveGynecol
WethankJakobHjortforhisgenerationofthe 4.WallwienerM,TaranFA,RothmundR,etal. 2013;20:424-34.
allocationsequenceandexcellentmanagement Laparoscopicsupracervicalhysterectomy(LSH) 20.LethabyA,MukhopadhyayA,NaikR.Total
of the randomization procedure and program; versus total laparoscopic hysterectomy (TLH): versus subtotal hysterectomy for benign
Kasper Munck (SAS Institute) for statistical animplementationstudyin1,952patientswith gynaecologicalconditions.CochraneDatabase
adviceandhelpwiththemultipleimputation;and ananalysisofriskfactorsforconversiontolap- SystRev2012:CD004993.
Per Winkel (Copenhagen Trial Unit) for advice arotomyandcomplications,andofprocedure- 21.IosifCS,BekassyZ,RydhstromH.Preva-
aboutmultipleimputation.Theremainingmem- specific re-operations. Arch Gynecol Obstet lence of urinary incontinence in middle-aged
bersoftheDanishHysterectomyTrialGroupare 2013;288:1329-39. women.IntJGynaecolObstet1988;26:255-9.
providedwiththefull-lengtharticleatajog.org. 5.SuttonC.Past,present,andfutureofhysterec- 22.Milsom I, Ekelund P, Molander U,
This study was registered at ClinicalTrials.gov tomy.JMinimInvasiveGynecol2010;17:421-35. ArvidssonL,AreskougB.Theinfluenceofage,
with the identifier number of NCT01880710. 6.FoodandDrugAdministration.Laparoscopic parity, oral contraception, hysterectomy and
The trial is registered on clinicaltrials.gov under uterinepowermorcellationinhysterectomyand menopauseontheprevalenceofurinaryincon-
Nykoebing Falster County Hospital Record myomectomy. Silver Spring, MD: Food and tinenceinwomen.JUrol1993;149:1459-62.
sj-268:Totalversussubtotalhysterectomy:http:// Drug Administration Safety Communication; 23.Gimbel H, Zobbe V, Andersen BJ, et al.
clinicaltrials.gov/ct2/show/NCT01880710?term¼ 2014. Lower urinary tract symptoms after total and
hysterectomy&rank¼27. The HysterectomyTrial 7.Kilkku P, Gronroos M, Hirvonen T, subtotalhysterectomy:resultsofarandomized
Group consists of the authors and of the RauramoL.Supravaginaluterineamputationvs. controlled trial. Int Urogynecol J Pelvic Floor
following members: Kristian Jakobsen, MD, hysterectomy. Effects on libido and orgasm. Dysfunct2005;16:257-62.
Helle Christina Sørensen, MD, Kim Toftager- ActaObstetGynecolScand1983;62:147-52. 24.GimbelH,ZobbeV,OttesenBS,TaborA.
Larsen,MD,DMSc,NiniMøller,MD,Department 8.KilkkuP.Supravaginaluterineamputationvs. Randomized clinical trial of total vs. subtotal
of Obstetrics and Gynecology, Nordsjællands hysterectomy. Effects on coital frequency and hysterectomy:validityofthetrialquestionnaire.
Hospital,Hillerød,Denmark;EllenMereteMad- dyspareunia. Acta Obstet Gynecol Scand ActaObstetGynecolScand2002;81:968-74.
sen, MD, Mogens Vejtorp, MD, DMSc, Helle 1983;62:141-5. 25.BjornerJB,ThunedborgK,KristensenTS,
Clausen, MD, PhD, Department of Obstetrics 9.KilkkuP,LehtinenV,HirvonenT,GronroosM. Modvig J, Bech P. The Danish SF-36 Health
and Gynecology, Herlev University Hospital, Abdominal hysterectomy versus supravaginal Survey: translation and preliminary validity
Herlev, Denmark. The authors’ contribution uterine amputation: psychic factors. Ann Chir studies.JClinEpidemiol1998;51:991-9.
included the following: H.M.G. designed and GynaecolSuppl1987;202:62-7. 26.SchaferJL,GrahamJW.Missingdata:our
wastheprincipalinvestigatoroftheoriginaltrial, 10.ThakarR,AyersS,ClarksonP,StantonS, view of the state of the art. Psychol Methods
created and validated the questionnaire, ManyondaI.Outcomesaftertotalversussub- 2002;7:147-77.
recruitedandrandomizedparticipants,andsent total abdominal hysterectomy. N Engl J Med 27.RatitchB,LipkovichI,O’KellyM.Combining
out questionnaires for the prior follow-ups. 2002;347:1318-25. analysisresultsfrommultiplyimputedcategori-
L.L.A. is responsible for sending out the 14 11.Persson P, Brynhildsen J, Kjolhede P. caldata.PharmaSUG2013;2013.
yearquestionnaires,handlingthedataandsta- A 1-yearfollow up of psychological well-being 28.GrahamCA,MallettVT.Raceasapredictor
tistical analysis, and drafting and revising the aftersubtotalandtotalhysterectomy—arand- of urinary incontinence and pelvic organ pro-
article.L.L.A.isthecorrespondingauthor.B.O., omisedstudy.BJOG2010;117:479-87. lapse.AmJObstetGynecol2001;185:116-20.
C.G.,A.T.,andV.Z.participated inthedesign 12.Zobbe V, Gimbel H, Andersen BM, et al. 29.ThomDH,vandenEedenSK,RaginsAI,etal.
andconductoftheoriginaltrialaswellasthis Sexuality after total vs. subtotal hysterectomy. Differencesinprevalenceofurinaryincontinence
follow-up.L.M.A.M.andE.H.participatedinthe ActaObstetGynecolScand2004;83:191-6. byrace/ethnicity.JUrol2006;175:259-64.
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APPENDIX
Supplementalmaterials
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