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Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

NCT ID: NCT01258413

Last Updated: 2010-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Background: Radical hysterectomy with pelvic lymphadenectomy is one of the FIGO (International Federation of Gynecology and Obstetrics) recommended treatments for early cervical cancer. The objective of this study was to compare radical hysterectomy by laparoscopic approach and open radical hysterectomy in a single center randomized clinical trial. Nevertheless, there are no finished randomized controlled trials comparing laparoscopic radical hysterectomy and abdominal radical hysterectomy although there is an ongoing trial.

Methods: Were enrolled 30 IA2 with lymph vascular space invasion and IB cervical cancer patients. Postoperative pain intensity was defined as primary endpoint and pain intensity was measured by a 10-point numeric rating scale. Secondary outcomes were: intraoperative and other postoperative outcomes, histopathological outcomes and 5-year follow-up. Data analysis is being done at this moment

Conditions

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Cervical Cancer Postoperative Pain

Keywords

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Cervical Cancer Radical hysterectomy, Laparoscopic Overall survival Disease-free five-years survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Radical Hysterectomy

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

Group Type EXPERIMENTAL

Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy

Intervention Type PROCEDURE

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

Abdominal radical hysterectomy

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

Group Type ACTIVE_COMPARATOR

Abdominal radical hysterectomy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy

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

Intervention Type PROCEDURE

Abdominal radical hysterectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Nossa Senhora da Conceicao

OTHER

Sponsor Role lead

Responsible Party

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Hospital Nossa Senhora da Conceição

Principal Investigators

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Leo F Limberger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Nossa Senhora da Conceição

Locations

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Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 24028441 (View on PubMed)

Other Identifiers

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CEPGHC: 65/99

Identifier Type: -

Identifier Source: org_study_id