NCT01258413

Brief Summary

The purpose of this study is to determine whether laparoscopic radical hysterectomy for early cervical cancer will has decreased postoperative pain intensity compared to abdominal radical hysterectomy with similar postoperative complications and survival rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 1999

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
Last Updated

December 24, 2010

Status Verified

November 1, 2010

Enrollment Period

4.3 years

First QC Date

December 9, 2010

Last Update Submit

December 22, 2010

Conditions

Cervical CancerPostoperative Pain

Keywords

Cervical CancerRadical hysterectomy, LaparoscopicOverall survivalDisease-free five-years survival

Outcome Measures

Primary Outcomes (1)

  • postoperative pain measured by a 10 point numeric rating scale

    The primary outcome is postoperative pain as measured by a 10-point numeric rating scale (NRS) during the postoperative period. Pain was assessed every six hours by nursing staff during a patient's usual postoperative care. The nursing staff was not aware of the study objective.

    around one week

Secondary Outcomes (3)

  • Intraoperative, perioperative and postoperative complication

    30 days or five years

  • Surgicopathological outcomes

    postoperatively

  • Overall survival and disease-free survival

    five years

Study Arms (2)

Laparoscopic Radical Hysterectomy

EXPERIMENTAL

uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy

Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy

Abdominal radical hysterectomy

ACTIVE COMPARATOR

uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy

Procedure: Abdominal radical hysterectomy

Interventions

Laparoscopic Radical Hysterectomy + pelvic lymphadenectomyPROCEDURE

uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by laparoscopic approach

Laparoscopic Radical Hysterectomy
Abdominal radical hysterectomyPROCEDURE

uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by abdominal approach

Abdominal radical hysterectomy

Eligibility Criteria

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

You may qualify if:

  • Women of 18 years or older referred to our service with histologically confirmed primary squamous, adenocarcinoma or adenosquamous cervical cancer diagnosed by biopsy or cervical conization, clinically FIGO (International Federation of Gynecologic and Obstetrics) staged IA2 with lymph vascular invasion, IB and II A.

You may not qualify if:

  • Patients with clinically advanced disease (IIB-IV), previous pelvic or abdominal radiotherapy, pregnancy, clinical diseases that would preclude one or both surgical approaches.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Related Publications (1)

  • Campos LS, Limberger LF, Stein AT, Kalil AN. Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial. Trials. 2013 Sep 12;14:293. doi: 10.1186/1745-6215-14-293.

    PMID: 24028441DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPain, Postoperative

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Leo F Limberger, M.D.

    Hospital Nossa Senhora da Conceição

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2010

First Posted

December 13, 2010

Study Start

November 1, 1999

Primary Completion

February 1, 2004

Study Completion

February 1, 2009

Last Updated

December 24, 2010

Record last verified: 2010-11

Locations

BR(1)