NCT01893333

Brief Summary

To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and efficacy by prospective randomized trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

5 years

First QC Date

June 10, 2013

Last Update Submit

May 27, 2017

Conditions

Cervical Cancer

Keywords

cervical cancernerve sparing radical hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of bladder dysfunction after surgery

    Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL

    5 days after the surgery

Secondary Outcomes (12)

  • rectal & anal function after surgery

    6, 12 months after surgery

  • Sexual function

    6, 12 months after surgery

  • Quality of life

    6, 12 months after surgery

  • operative time

    immediately after surgery

  • amount of bleeding in operation

    immediately after surgery

  • +7 more secondary outcomes

Study Arms (2)

Nerve sparing radical hysterectomy group

EXPERIMENTAL

1. sparing hypogastric nerve 2. sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament 3. sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve

Procedure: Nerve sparing radical hysterectomy

Radical hysterectomy group

ACTIVE COMPARATOR

Conventional radical hysterectomy

Procedure: Nerve sparing radical hysterectomy

Interventions

Nerve sparing radical hysterectomyPROCEDURE

Nerve sparing radical hysterectomy 1. sparing hypogastric nerve 2. sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament 3. sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve

Nerve sparing radical hysterectomy groupRadical hysterectomy group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically diagnosed cervical cancer
  • FIGO stage IA2-IIA
  • Diameter of tumor is less than 4cm on exam
  • One of hitological type written below squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
  • Age between 18-70
  • Performance status; GOG 0-1
  • Normal hematological, hepatic, nephrologic function WBC ≥ 4000 cells/mm3 Platelet ≥ 100,000 /mm3 Hemoglobin ≥ 8.0 gm/dL Serum creatinin ≤ 1.3 mg/dL Serum bilirubin ≤ 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase \< normal X 3
  • Patient with informed consent
  • Small cell carcinoma
  • Unable to perform surgery because of severe underlying medical disease severe heart disease, congestive heart failure/severe pulmonary disease, pulmonary failure/ active bacterial infectio which needs non oral antibiotic therapy/ associated with other severe medical diseases
  • Prior chemotherapy or radiotherapy
  • Severe bladder funtion abnormality
  • Double primary malignant tumor
  • Psychiatric problems
  • Pregnant or breast feeding status
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Joo-Hyun Nam, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo-Hyun Nam, M.D., Ph.D.

CONTACT

82-2-3010-3633jhnam@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2013

First Posted

July 9, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

KR(1)