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The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer (NSRHCXCA)

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nerve sparing radical hysterectomy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, nerve sparing radical hysterectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion creteria:

  • 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
  • Legally unable to participate clinical trial
  • When there is a Doctor's decision that patient is unable to participate clinical trial

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nerve sparing radical hysterectomy group

Radical hysterectomy group

Arm Description

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

Conventional radical hysterectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

rectal & anal function after surgery
Sexual function
Quality of life
operative time
amount of bleeding in operation
frequency of blood transfusion
amount of blood transfusion
postoperative complication
time from surgery to return to work
management cost
size of resected parametrial tissue
2year disease free survival

Full Information

First Posted
June 10, 2013
Last Updated
May 27, 2017
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01893333
Brief Title
The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Acronym
NSRHCXCA
Official Title
The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer, nerve sparing radical hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nerve sparing radical hysterectomy group
Arm Type
Experimental
Arm Description
sparing hypogastric nerve sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve
Arm Title
Radical hysterectomy group
Arm Type
Active Comparator
Arm Description
Conventional radical hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Nerve sparing radical hysterectomy
Intervention Description
Nerve sparing radical hysterectomy sparing hypogastric nerve sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve
Primary Outcome Measure Information:
Title
Incidence of bladder dysfunction after surgery
Description
Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL
Time Frame
5 days after the surgery
Secondary Outcome Measure Information:
Title
rectal & anal function after surgery
Time Frame
6, 12 months after surgery
Title
Sexual function
Time Frame
6, 12 months after surgery
Title
Quality of life
Time Frame
6, 12 months after surgery
Title
operative time
Time Frame
immediately after surgery
Title
amount of bleeding in operation
Time Frame
immediately after surgery
Title
frequency of blood transfusion
Time Frame
within 1 week after surgery
Title
amount of blood transfusion
Time Frame
within 1 week after surgery
Title
postoperative complication
Time Frame
within 1 month after surgery
Title
time from surgery to return to work
Time Frame
within 1 month after surgery
Title
management cost
Time Frame
within 1 week after surgery
Title
size of resected parametrial tissue
Time Frame
immediately after surgery
Title
2year disease free survival
Time Frame
2 year after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion creteria: 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 Legally unable to participate clinical trial When there is a Doctor's decision that patient is unable to participate clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Hyun Nam, M.D., Ph.D.
Phone
82-2-3010-3633
Email
jhnam@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Phone
82-2-3010-3633
Email
jhnam@amc.seoul.kr

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer

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