Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection

Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection for Early Gynecological Cancer

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

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Lymphocele
• Intervention / Treatment: Procedure: Peritoneal closure; Procedure: Retroperitoneal drainage

Detailed Description

To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection by reviewing the medical records of patients who underwent retroperitoneal lymph node dissection for stage I or II gynecological cancer in Far Eastern Memorial Hospital, January 2011~December 2017.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei
    • Banqiao, New Taipei, Taiwan, 22050
      • Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• nil

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors predicting lymphocele occurrence	To find independent factors that can predict lymphocele occurrence in patients who underwent laparotomic gynecologic oncologic surgery	10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors predicting surgical complication	To find independent factors that can predict occurrence of surgical complication in patients who underwent laparotomic gynecologic oncologic surgery	10 years

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): February 12, 2019
• Study Completion (Actual): March 25, 2019

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Cysts; Lymphocele
• Other Study ID Numbers: 107150-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No