Treatment for Malignant Ovarian Cancer: Laparoscopy vs Laparotomy
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|ClinicalTrials.gov Identifier: NCT02686463|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2016
Last Update Posted : February 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Procedure: Laparoscopy Procedure: Laparotomy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Diagnosis and Treatment of Laparoscopy for Malignant Ovarian Cancer: an Open-label, Parallel, Randomized, Controlled Clinical Trial of Efficacy and Safety|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2023|
Experimental: the laparoscopy group
Patients who are randomized to the laparoscopy group.
Laparoscopy is an operation performed in the abdomen or pelvis through small incisions (usually 0.5-1.5 cm) with the aid of a camera. It can either be used to inspect and diagnose a condition or to perform surgery.
Experimental: the laparotomy group
Patients who are randomized to the laparotomy group.
A laparotomy is a surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity. It is also known as a celiotomy.
- Progression free survival [ Time Frame: 5 years ]Time to recurrence
- Overall survival [ Time Frame: 5 years ]Time to last follow up/death
- Operative complication rate [ Time Frame: 30 days ]Intra- and post-operative complication rate of both group
- Quality of life after surgery [ Time Frame: Baseline, 1 week, 1 month, 3 months and 1 year after surgery ]Quality of life before surgery, and at 1 week, 1 month, 3 months and 1 year after surgery in both groups will be evaluated using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686463
|Contact: Guangwei Wang, M.D.||+firstname.lastname@example.org|
|Principal Investigator:||Qing Yang, M.D.||Shengjing Hospital|