NCT03765320

Brief Summary

To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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 6, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

December 4, 2018

Last Update Submit

October 19, 2019

Conditions

LymphoceleGynecologic Cancer

Outcome Measures

Primary Outcomes (1)

  • Factors predicting lymphocele occurrence

    To find independent factors that can predict lymphocele occurrence in patients who underwent laparotomic gynecologic oncologic surgery

    10 year

Secondary Outcomes (1)

  • Factors predicting surgical complication

    10 years

Interventions

Peritoneal closurePROCEDURE

Peritoneal closure after pelvic lymph node dissection for early gynecologic cancer

Retroperitoneal drainagePROCEDURE

Retroperitoneal drainage after pelvic lymph node dissection for early gynecologic cancer

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Early gynecologic cancer patients who underwent retroperitoneal lymph node dissection in Far Eastern Memorial Hospital between January 2011 and December 2017.

You may qualify if:

  • Stage I or stage II gynecologic cancer (including cervical cancer, endometrial cancer, ovarian cancer, and fallopian tube cancer)
  • Underwent laparotomic gynecologic oncologic surgery, including retroperitoneal lymphadenectomy.

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Lymphocele

Condition Hierarchy (Ancestors)

CystsNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 5, 2018

Study Start

November 6, 2018

Primary Completion

February 12, 2019

Study Completion

March 25, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

TW(1)