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Trial record 18 of 597 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

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
Sponsor:
Information provided by (Responsible Party):
Qing Yang, Shengjing Hospital

Brief Summary:
This trial is designed to compare diagnostic and therapeutic effects of laparoscopy vs. laparotomy on early malignant ovarian cancer, and to evaluate the efficacy and safety of laparoscopy in early malignant ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: Laparoscopy Procedure: Laparotomy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: the laparoscopy group
Patients who are randomized to the laparoscopy group.
Procedure: Laparoscopy
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.
Procedure: Laparotomy
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.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 5 years ]
    Time to recurrence


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Time to last follow up/death

  2. Operative complication rate [ Time Frame: 30 days ]
    Intra- and post-operative complication rate of both group

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preoperative examination indicates highly suspected early stage of ovarian cancer.
  • This is the first time treatment to the patient for the ovarian cancer.
  • Family consents are granted.

Exclusion Criteria:

  • Pregnancy or breast-feeding women
  • History of multiple pelvic surgeries; severe adhesions suspected at the surgical area
  • Highly allergic constitution or a history of severe allergies
  • Systemic infection or severe local infection
  • Age younger than 18 years old or older than 65 years old
  • Severe cardiopulmonary disease, liver and kidney dysfunction and other severe underlying disease
  • Poor compliance (cannot finish the trial) or the investigator believes that the patient is not appropriate for treatment

Information from the National Library of Medicine

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


Contacts
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Contact: Guangwei Wang, M.D. +8618940228389 wanggw@sj-hospital.org

Sponsors and Collaborators
Shengjing Hospital
Investigators
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Principal Investigator: Qing Yang, M.D. Shengjing Hospital

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Responsible Party: Qing Yang, Vice President, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT02686463     History of Changes
Other Study ID Numbers: QYang_001
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Qing Yang, Shengjing Hospital:
malignant ovarian cancer
laparoscopy
laparotomy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma