Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
13. marts 2018 opdateret af: Wang Jianliu
The purpose of this study is to investigate the effect of electric stimulation on the pelvic floor function in cervical cancer patients with type III hysterectomy.
Studieoversigt
Detaljeret beskrivelse
This is a prospective, multi center, open, randomized, controlled clinical trial.
All cervical carcinoma patients who undergo type III hysterectomy in the hospitals involved in this study were recruited.
5-7 days postoperative, those who meet the inclusion criteria and without the exclusion criteria and sign the consent were randomized grouped of intervention and control objective by 1:1.
At the same time, according to the research hospital, menopausal status (menopause vs menopause) and surgery approach (laparoscopic vs open)，they were further stratified randomly.
Patients in the intervention group received electrical stimulation treatment based on conventional clinical nursing, while patients in control group only receive routine clinical care.
Except for the treatment of electrical stimulation, other research procedures is the same in the two groups.
The recovery rate of urination function, pelvic floor function and life quality of the two group is compared.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
208
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Patients diagnosed as cervical squamous cell carcinoma on Ⅰa2, Ib1 or Ⅱa1 stage
- Type III hysterectomy
- There are pathological results showing that cancer resection clean and no distant metastasis,Specifically as follows:Lymph nodes(-);cancer foci invasion depth <1/2;Lymphatic space(-);Vaginal stump(-);differentiation G1-2.
- Patients agreed to the study, informed consent
Exclusion Criteria:
- Radiotherapy and chemotherapy before surgery
- Reserved nerve in the surgery
- Urinary system damage
- POP(Pelvic Organ Prolapse stage)>II stage before surgery
- Moderate above stress urinary incontinence(SUI) before surgery(1 hours urine pad test>=10g)
- Urinary retention before surgery
- Severe constipation or difficult defecation before surgery
- There are uncontrolled epilepsy, central nervous system disease or mental disorder history in patients.The clinical severity of these diseases Influence clinical research compliance,judging by the researcher.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Electric Stimulation Treatment
Patients in the intervention group were treated with electric stimulation based on the routine clinical nursing.
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Electrical stimulation program: frequency: 1/4/Hertz (HZ), pulse width: 270/230/270 μs, time: 30min.
Electrode piece: 50*50mm sticky electrode plate.
Position: an electrode piece is placed in the S3, and an electrode piece is placed in the bladder region.Current intensity adjusted according to the patient's tolerance, the maximum current intensity of the pain was not appropriate, generally not more than 100milliampere(mA).Devices PHENIX USB 8.
Andre navne:
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Ingen indgriben: control group
patients in this group only received routine clinical nursing without electric stimulation
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Urination function recovery rate
Tidsramme: From 14 days to 24 months after operation
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From 14 days to 24 months after operation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with recovery of defecation function and urinary function after III hysterectomy
Tidsramme: From 14 days to 24 months after operation
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From 14 days to 24 months after operation
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Quality of life Questionnaire
Tidsramme: From 14 days to 24 months after operation
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From 14 days to 24 months after operation
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Overall Survival
Tidsramme: From 14 days to 24 months after operation
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The overall survival (OS) in cervical cancer patients after 3 years' III hysterectomy after comparison of pelvic floor rehabilitation therapy and control group
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From 14 days to 24 months after operation
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Disease-free survival
Tidsramme: From 14 days to 24 months after operation
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Comparison of pelvic floor rehabilitation treatment group and control group of cervical cancer patients with type III hysterectomy 3 years disease-free survival (DFS)
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From 14 days to 24 months after operation
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Wang J liu, Doctor, Peking University People's Hospital Ob and Gy
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Plotti F, Angioli R, Zullo MA, Sansone M, Altavilla T, Antonelli E, Montera R, Damiani P, Benedetti Panici P. Update on urodynamic bladder dysfunctions after radical hysterectomy for cervical cancer. Crit Rev Oncol Hematol. 2011 Nov;80(2):323-9. doi: 10.1016/j.critrevonc.2010.12.004. Epub 2011 Jan 31.
- Griffenberg L, Morris M, Atkinson N, Levenback C. The effect of dietary fiber on bowel function following radical hysterectomy: a randomized trial. Gynecol Oncol. 1997 Sep;66(3):417-24. doi: 10.1006/gyno.1997.4797.
- Raspagliesi F, Ditto A, Fontanelli R, Zanaboni F, Solima E, Spatti G, Hanozet F, Vecchione F, Rossi G, Kusamura S. Type II versus Type III nerve-sparing radical hysterectomy: comparison of lower urinary tract dysfunctions. Gynecol Oncol. 2006 Aug;102(2):256-62. doi: 10.1016/j.ygyno.2005.12.014. Epub 2006 Jan 30.
- Jackson KS, Naik R. Pelvic floor dysfunction and radical hysterectomy. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):354-63. doi: 10.1111/j.1525-1438.2006.00347.x.
- Sood AK, Nygaard I, Shahin MS, Sorosky JI, Lutgendorf SK, Rao SS. Anorectal dysfunction after surgical treatment for cervical cancer. J Am Coll Surg. 2002 Oct;195(4):513-9. doi: 10.1016/s1072-7515(02)01311-x.
- Axelsen SM, Petersen LK. Urogynaecological dysfunction after radical hysterectomy. Eur J Surg Oncol. 2006 May;32(4):445-9. doi: 10.1016/j.ejso.2006.01.017. Epub 2006 Mar 3.
- Butler-Manuel SA, Summerville K, Ford A, Blake P, Riley AJ, Sultan AH, Monga AK, Stanton SL, Shepherd JH, Barton DP. Self-assessment of morbidity following radical hysterectomy for cervical cancer. J Obstet Gynaecol. 1999 Mar;19(2):180-3. doi: 10.1080/01443619965552.
- Manchana T, Sirisabya N, Lertkhachonsuk R, Worasethsin P, Khemapech N, Sittisomwong T, Vasuratna A, Termrungruanglert W, Tresukosol D. Long term complications after radical hysterectomy with pelvic lymphadenectomy. J Med Assoc Thai. 2009 Apr;92(4):451-6.
- Sansone M, Plotti F, Panici PB. Long-term lower urinary tract dysfunction after radical hysterectomy in patients with early postoperative voiding dysfunction. Int Urogynecol J. 2010 Oct;21(10):1309-10; author reply 1311-2. doi: 10.1007/s00192-010-1206-1. Epub 2010 Jun 23. No abstract available.
- Barnes W, Waggoner S, Delgado G, Maher K, Potkul R, Barter J, Benjamin S. Manometric characterization of rectal dysfunction following radical hysterectomy. Gynecol Oncol. 1991 Aug;42(2):116-9. doi: 10.1016/0090-8258(91)90329-4.
- Ye S, Yang J, Cao D, Lang J, Shen K. A systematic review of quality of life and sexual function of patients with cervical cancer after treatment. Int J Gynecol Cancer. 2014 Sep;24(7):1146-57. doi: 10.1097/IGC.0000000000000207.
- Maddocks M, Lewis M, Chauhan A, Manderson C, Hocknell J, Wilcock A. Randomized controlled pilot study of neuromuscular electrical stimulation of the quadriceps in patients with non-small cell lung cancer. J Pain Symptom Manage. 2009 Dec;38(6):950-6. doi: 10.1016/j.jpainsymman.2009.05.011.
- Bennett MI, Johnson MI, Brown SR, Radford H, Brown JM, Searle RD. Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain. J Pain. 2010 Apr;11(4):351-9. doi: 10.1016/j.jpain.2009.08.002. Epub 2009 Oct 22.
- Robb K, Oxberry SG, Bennett MI, Johnson MI, Simpson KH, Searle RD. A cochrane systematic review of transcutaneous electrical nerve stimulation for cancer pain. J Pain Symptom Manage. 2009 Apr;37(4):746-53. doi: 10.1016/j.jpainsymman.2008.03.022. Epub 2008 Sep 14.
- Yang EJ, Lim JY, Rah UW, Kim YB. Effect of a pelvic floor muscle training program on gynecologic cancer survivors with pelvic floor dysfunction: a randomized controlled trial. Gynecol Oncol. 2012 Jun;125(3):705-11. doi: 10.1016/j.ygyno.2012.03.045. Epub 2012 Apr 1.
- Ryu JS, Kang JY, Park JY, Nam SY, Choi SH, Roh JL, Kim SY, Choi KH. The effect of electrical stimulation therapy on dysphagia following treatment for head and neck cancer. Oral Oncol. 2009 Aug;45(8):665-8. doi: 10.1016/j.oraloncology.2008.10.005. Epub 2008 Dec 17.
- Wang S, Gao L, Wen H, Gao Y, Lv Q, Li H, Wang S, Wang Y, Liu Q, Han J, Wang H, Li Y, Yu N, Wang Q, Cao T, Wang S, Sun H, Wang Z, Sun X, Wang J. Evaluation of pelvic floor muscle function (PFMF) in cervical cancer patients with Querleu-Morrow type C hysterectomy: a multicenter study. Arch Gynecol Obstet. 2022 Feb;305(2):397-406. doi: 10.1007/s00404-021-06290-6. Epub 2021 Oct 28.
- Li XW, Gao L, Wang Q, Lv QB, Xia ZJ, Wen HW, Han JS, Wu YM, Wang SM, Liu Q, Li H, Wang HB, Li Y, Wang SY, Wang ZQ, Sun XL, Wang JL. Long-Term Effect of Early Post-operative Transcutaneous Electrical Stimulation on Voiding Function After Radical Hysterectomy: A Multicenter, Randomized, Controlled Trial. Front Med (Lausanne). 2021 Sep 30;8:677029. doi: 10.3389/fmed.2021.677029. eCollection 2021.
- Sun XL, Wang HB, Wang ZQ, Cao TT, Yang X, Han JS, Wu YF, Reilly KH, Wang JL. Effect of transcutaneous electrical stimulation treatment on lower urinary tract symptoms after class III radical hysterectomy in cervical cancer patients: study protocol for a multicentre, randomized controlled trial. BMC Cancer. 2017 Jun 15;17(1):416. doi: 10.1186/s12885-017-3387-1.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2015
Primær færdiggørelse (Forventet)
1. december 2018
Studieafslutning (Forventet)
1. december 2019
Datoer for studieregistrering
Først indsendt
25. juni 2015
Først indsendt, der opfyldte QC-kriterier
7. juli 2015
Først opslået (Skøn)
8. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D151100001915003
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .