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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765320
• Other study ID #: 107150-E
• Status: Completed
• Start date: November 6, 2018
• Est. completion date: March 25, 2019

Study information

• Verified date: October 2019
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 25, 2019
• Est. primary completion date: February 12, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Lymphocele

Intervention

Procedure:
• Peritoneal closure
Peritoneal closure after pelvic lymph node dissection for early gynecologic cancer
• Retroperitoneal drainage
Retroperitoneal drainage after pelvic lymph node dissection for early gynecologic cancer

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors predicting lymphocele occurrence	To find independent factors that can predict lymphocele occurrence in patients who underwent laparotomic gynecologic oncologic surgery	10 year
Secondary	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