Professor and HOD, Department of OBG, Adichunchanagiri Institute of Medical Sciences, B.G. Nagara, Karnataka, IndiaIndia
Senior Resident, Department of OBG, Adichunchanagiri Institute of Medical Sciences, B.G. Nagara, Karnataka, IndiaIndia
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Hysterectomy is a widely performed surgical procedure for benign gynecological conditions such as uterine fibroids, abnormal uterine bleeding, and endometriosis. This randomized controlled trial compares total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH) in terms of surgical outcomes and quality of life (QoL). Sixty participants were randomized into two groups: TLH (n=30) and TAH (n=30). TLH demonstrated reduced blood loss, shorter hospital stays, and higher QoL scores on the RAND-36 questionnaire compared to TAH, despite longer operating times. These findings reinforce TLH as the preferred approach for managing benign gynecological conditions.
Keywords: TAH; TLH; Quality of life; Surgical outcome; RAND-36; Qualityoflife; Surgicaloutcome
Hysterectomy,thesurgicalremovalofuterusisoneof thegynaecologicaloperationsperformedduetobenignindicationssuchasuterineleiomyoma,abnormal uterinebleeding,endometrialhyperplasia,dysmenorrhea,dyspareunia,andsevereendometriosisrefractorytomedicalorconservativesurgicalmanagement orincasesofrejectionbythepatient[1].Manysymptomsthatemergepriortohysterectomysuchasheavy andprolongedmenstrualbleeding,chronicpelvicpain, dyspareunia,anddysmenorrheanegativelyaffectthe qualityoflife.Itcanbeexpectedthatahysterectomy madetorelievethesesymptomscanalsoshowpositiveeffectsonpatient’squalityoflife[2]. Theroute ofhysterectomydependsonthepathology,sizeand descentoftheuterus,presenceofendometriosis,the likelihoodofadhesions,previouspelvicsurgery,surgeon’spreference,andpatient’schoice[3].
Totallaparoscopichysterectomyisaminimallyinvasive surgerythataimstoachievesimilarclinicaleffectivenesswithaquickerrecoverythantraditionalabdominalhysterectomy.Becauseoflowercomplicationsand lowerpostoperativepain,lessbloodloss,shorterhospitalizationperiod,shorterhealingtimeandearlyreturnofdailyactivities,laparoscopichysterectomyhas moreadvantagesthanabdominalhysterectomy[4].Laparoscopichysterectomyinvolveslesstissuetrauma andlessinflammatoryresponseduringsurgerywhich resultsinlesspostoperativepainandshorterhealing period. Thedisadvantagesoflaparoscopichysterectomyincludeinjuriestotheurinarytractandlonger operationtime[5]. Butthesetwocomplicationscan bereducedwithimprovementofsurgeon’sskillsand wideruseoflaparoscopicapproachofhysterectomy[6]. Laparoscopichysterectomieshavebeendividedinto threetypes: LAVH(laparoscopicallyassistedvaginal hysterectomy),LH(laparoscopichysterectomy),and TLH(totallaparoscopichysterectomy)[7].TLHinvolves theproceduredonecompletelybylaparoscopewithoutthevaginalcomponentexceptfortheremovalof the uterus by the vaginal route. Although the operatingtimerequiredforlaparoscopichysterectomyis long,theproportionoflaparoscopichysterectomyhas graduallyincreased.Themainadvantagesarethepossibilityofdiagnosingandtreatingotherpelvicdiseases suchasendometriosis,ofcarryingoutadnexalsurgery includingtheremovaloftheovaries,theabilitytosecurethoroughintraperitonealhaemostasis(directlaparoscopicvisionenablescarefulsealingofbleeding vesselsattheendoftheprocedure),andamorerapid recoverytimefromsurgerycomparedtoabdominal hysterectomy[8].
TAH(totalabdominalhysterectomy)isanaccepted,effective,andeasilyperformedprocedureandamore invasiveprocedurethanlaparoscopichysterectomy[9]. Thetraditionalapproachofabdominalhysterectomy isinevitableinmanysituations[10-12].Moreover,gynaecologistsareprimarilytrainedthroughtheabdominalroutecomparedtovaginalandlaparoscopictechniques[13]. Abdominalapproachisassociatedwith anincreasedlengthofhospitalstay,lessrapidreturn tonormalactivities,andmarkedincreaseinsurgical siteinfectionrates.Therefore,theabdominalroutefor hysterectomyisbestreservedforsituationsinwhich minimallyinvasiveapproachesarenotreasonable.Althoughabdominalhysterectomycontinuestobethe mostcommonapproachusedworldwide,thereisgood evidencefrommultiplerandomized,prospectivetrials thatvaginalandlaparoscopichysterectomiesareassociatedwithfewercomplications,ashorterhospitalstay, amorerapidrecovery,andloweroverallcosts. Most patientswithgynaecologicmalignancyarestilloperatedonwithanabdominalincision. Auteruslarger than12weeks’gestationalsizeisareasonablesizeto qualifyforanabdominalapproach.Theshapeandsize ofthepelvicoutletarealsokeyfactors[14].
Thisstudyisaimedatevaluatingthesurgicaleffects, bothshort-termandlong-termeffectsinwomenwho underwentTLHandTAHduetobenignindicationsand qualityoflifepost-surgery.Thereareveryfewstudies comparingthequalityoflifeafterTLHvsTAH.Therefore,themainfocusofthisstudyistoevaluatehow andatwhatperiodoftime, thepatientexperiences the benefits of the surgery after being suffered due toanybenigngynaecologicalconditionsthataffected theirlife(bothphysicalandpsychological)andtoevaluatetheoutcomesofthesurgeryperformedtorelieve womenoftheirdisease.
This randomized controlled trial was conducted at AdichunchanagiriHospitalandResearchCenterfrom September2022toMay2024.Sixtywomenaged30–60 years,diagnosedwithbenigngynecologicalconditions, wererecruited.Participantswererandomizedintotwo groups:TLH(n=30)andTAH(n=30).
1. Womenwithbenigngynaecologicalconditions suchasabnormaluterinebleedingwithleiomyoma,adenomyosis,endometriosis,endometrial polyp,endometrialhyperplasia,benignovarian tumour.
2. Womenabove40yearsofage.
3. Womenwhohavecompletedafamily.
4. Womenwhohavetakenmedicaltreatmentand havenotbeenrelievedofsymptoms.
1. Suspicion of malignancy – endometrial carcinoma,cervicalcarcinoma,ovariancarcinoma. 2. Women with uterovaginal prolapse requiring pelvicfloorrepair/vaginalhysterectomy.
3. Womenwhorefusetoanswerqualityoflifequestionnaireswillbeexcludedfromthestudy.
StudywascarriedoutindepartmentofOBG,AdichunchanagiriHospitalandResearchCentre,BGNagar.Institutionalethicalcommitteeclearancewasobtained priortobeginstudy. Purposeofstudyandinterventionsareclearlyexplainedtoallparticipantsintheirunderstandablelanguage.Consentedparticipantsfulfillinginclusioncriteriaarerecruitedfrominpatientwards ofgynaecologydepartment. Participantswithexclusionfactorsareexcludedfromstudy.Sameprocedure followedtillcompleterecruitmentofallparticipants. Participants’detailedhistorywiththefollowing:name, age,education,socio-economicstatus,occupation,address,marriedlife,pastmedicalandsurgicalhistory, familyhistory.Generalphysicalexamination,systemic examination,gynaecologyexaminationisdone. Participantsarerandomisedintointerventionorcontrol armbycomputergeneratedrandomnumber. Block randomizationwithblocksizeof5donetomaintain equalparticipantsinbothgroups. Allocationisconcealedbyusingsequentiallynumberedopaquesealed envelopes(infourseparatesets)thatcontaingroup assignmentsdeterminedbycomputer-generatedrandomsequences.Principalinvestigatorgivesthesealed envelopetothehealthcareworkerwhoisintended tocarryoutintervention.Beforesurgery,patientsunderwentroutineexaminations,bloodtests,gynaecologicalexamination,gynaecologicalultrasoundscanning,papsmearandendometrialbiopsy.Patientsreceived antibiotic prophylaxis. All patients were routinelycatheterizedatthebeginningofoperation.Both TLHandTAHwereperformedundergeneralanaesthesia.
Preoperative assessments included medical history, physicalexamination,andimagingstudies.Postoperativeevaluationsfocusedonsurgicaloutcomessuchas bloodloss,operatingtime,andhospitalstay.Quality oflifewasassessedsixweekspostoperativelyusingthe RAND-36questionnaire,avalidatedtoolthatmeasures physical,emotional,andsocialfunctioning.
Theentiredatawillbevalidatedbycheckingforand correctinganyunusualvaluesandtypographicerrors. Allthequantitativevariableswillbecheckedforcompliance with normal distribution, within each study groupbyusingvisualinspectionofhistogramsandnormalityQ-Qplots.SkewnessandKurtosisZ-valuesand Shapiro-WilktestP-valueswillalsobeusedforthispurpose.Themeanandstandarddeviationofthenormally distributedquantitativevariableswillbecomparedbetweenthetwogroupsusingindependentsamplet-test. ThemedianandInterQuartileRange(IQR)ofthenonnormallydistributedquantitativevariableswillbecomparedbetweenthetwogroups,usingMann-Whitney Utest.ThequalitativevariableswillbecomparedbetweenthetwomethodsusingChi-squaretest/Fisher’s exacttest.
Table 1. Distributionofparticipantsbasedon co-morbidities
24 18 42 Nil 80.0% 60.0% 70.0% 0 3 3 DM 0.0% 10.0% 5.0% 3 3 6 HTN 10.0% 10.0% 10.0% 2 3 5 Hypothyroidism 6.7% 10.0% 8.3% 1 3 4 Others 3.3% 10.0% 6.7% 30 30 60 Total 100.0% 100.0% 100.0% Chi-squaretest–5.2withPvalue–0.12
Table 2. Distributionofparticipantsbasedon diagnosis
15 19 34 Fibroid 51.7% 65.5% 58.6% 11 9 20 Adenomyosis 37.9% 31.0% 34.5% 3 1 4 Other 10.3% 3.4% 6.9% 29 29 58 Total 100.0% 100.0% 100.0% Chi-squaretest–1.2withPvalue–0.54
Theanalysisrevealedsignificantdifferencesinsurgical outcomesandqualityoflifebetweentheTLHandTAH groups.
Thekeyfindingswereasfollows: ofbloodlossduringsurgery
23 1 24 <200ml 82.1% 3.3% 41.4% 200–400ml 17.9% 33.3% 25.9% >500ml 0.0% 63.3% 32.8% 28 30 58 Total 100.0% 100.0% 100.0% Chi-squaretest–40.8withPvalue– <0.00001
Table 4. Distributionofparticipantsbasedonduration ofsurgery
TLH 144.17 48.6 TAH 113.67 18.7 ∗ ∗IndependentTtest
1. BloodlossinTLHislesscomparedtoTAH.82.1% ofpatientswhounderwentTLHhadlessthan200 mlbloodloss.Thedifferencebetweenthetwo groupswassignificantwithPvalue <0.00001. 2. The operating time was longer in TLH than in TAH.MeandurationofsurgeryamongTLHwas 144.17minutes.Pvalueis0.001.
3. The TLH group’s mean RAND 36 score was 15.5±8.83,whiletheTAHgroup’swas14.3±7.74.
Incurrentstudymostoftheparticipants(63.3%)inTAH grouphadbloodlossofmorethan500ml,whereas in TLH group blood loss was significantly lower (P <0.002).InastudydonebyAgarwalPetal.,average intraoperativebloodlosswassignificantlylowerinTLH asopposedtoTAH.Similarresultswerealsoobserved byBaeketal.[15]andSutasanasuang[16].Inastudy donebyShakuntla,etal.[17],meanbloodlossintheir study was (35.21±19.61 ml) for the TLH group, this becauseofadventofelectrocoagulationsystem,comparedto(138.4±58.6ml)fortheTAHgroup,anditwas statisticallysignificant.
IncurrentstudymeanscoreofRAND36scoreamong ± TLH group was 15.5 8.83 and among TAH group ± was14.3 7.74.Differenceobservedbetweengroups amongrolelimitationsduetoemotionalproblems,energy/fatigue,andpainwerefoundtobestatisticallysignificant.InastudydonebyShakuntla,etal.[12],mean painscoreinTLHwas(2.56±0.97)andthemedianpain scorewas2witharangeof1–5,andinTAHgroupmean painscorewas(5.31±1.02)andthemedianpainscore was5witharangeof4–8.Thisdifferencewasfoundto bestatisticallysignificant,i.e.,themedianpainscore 5 10 15 wassignificantlylessinTLHgroupascomparedtoTAH group.
0 19 19
Incurrentstudy,complicationsobservedamongTAH group:uretericinjurywasseeninoneparticipant,rectussheathhematomainoneparticipant,andfiveparticipantshadfeverandtwohadwoundgapingneedingsecondarysuturing.InTLHgrouponeparticipant hadbladderinjury,fiveparticipantshadportsiteinfectionandthreeparticipantshadportsinustractfor- 12.08 0.001 mation. In the study done by Agarwal M et al. [18], theoverallrateofcomplicationswasseentobe3.1% in the TLH group (11/344) as compared to 11.7% in theTAHgroup(30/256),withthebulkofcomplications requiringconservativemanagement.TherateofpostoperativeurinarytractinfectioninTLHwasalmostnil comparedtoTAH,indicatingTLHtobesafeandlessinvasive,thusprotectingagainsthospital-acquiredinfections.Healthcare-associatedUTIs(HAUTIs)represent thelargestsubtypeamongallhealthcare-associated infections. TheprevalenceofHAUTIsassessedinregionalstudiesrangesfrom12.9%intheUSand19.6% inEuropetoupto24%indevelopingcountries[19]. InthestudydonebyAgarwalMetal. [18],onecase eachofbowelinjurywasnotedintheTLHversusTAH group. Bothcaseshaddelayeddiagnosis(2–3days), thussubjectingthepatienttocolostomywithprimary repair.
Thestudy’ssingle-centerdesignandrelativelysmall samplesizemaylimitthegeneralizabilityofthefindings.Futureresearchinvolvinglarger,multicentertrialsisnecessarytovalidatetheseresultsandexplore long-termoutcomes.
Totallaparoscopichysterectomy(TLH)offerssignificantadvantagesovertotalabdominalhysterectomy (TAH)formanagingbenigngynecologicalconditions. This study confirms that TLH improves surgical outcomes,enhancesqualityoflife,andfacilitatesfaster recovery.
Physicalfunctioning Rolelimitationsdueto TLH 86.683 20.7193 emotionalproblems TAH 40.017 43.0290 Energy/fatigue
Emotionalwell-being
Pain
Socialfunctioning
Generalhealth
Healthchange
RAND36
Uretericinjury 1 Bladderinjury 0 Anaesthesiaproblems 0 Bloodloss >1000ml 0 Hematoma 1rectussheathhematoma 0 Hematomaneedingsurgery 0 Pulmonaryembolism 0 Infectionorfever 5fever 5portsiteinfection Vaultproblems 0
Others