Effect of Pelvic Floor Stimulation on the Pelvic Floor Function in Cervical Cancer Patients With Type III Hysterectomy
13. mars 2018 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
208
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 navn:
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Ingen inngripen: control group
patients in this group only received routine clinical nursing without electric stimulation
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Hva måler studien?
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Wang J liu, Doctor, Peking University People's Hospital Ob and Gy
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2015
Primær fullføring (Forventet)
1. desember 2018
Studiet fullført (Forventet)
1. desember 2019
Datoer for studieregistrering
Først innsendt
25. juni 2015
Først innsendt som oppfylte QC-kriteriene
7. juli 2015
Først lagt ut (Anslag)
8. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D151100001915003
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