Treatment for Malignant Ovarian Cancer: Laparoscopy vs Laparotomy

NCT02686463 | Unknown

• 1 other identifier: QYang_001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Cancer

Keywords

malignant ovarian cancer; laparoscopy; laparotomy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Time to recurrence

  5 years

Secondary Outcomes (3)

• Overall survival

  5 years

• Operative complication rate

  30 days

• Quality of life after surgery

  Baseline, 1 week, 1 month, 3 months and 1 year after surgery

Study Arms (2)

the laparoscopy group

EXPERIMENTAL

Patients who are randomized to the laparoscopy group.

Procedure: Laparoscopy

the laparotomy group

EXPERIMENTAL

Patients who are randomized to the laparotomy group.

Procedure: Laparotomy

Interventions

Laparoscopy PROCEDURE

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.

the laparoscopy group

Laparotomy PROCEDURE

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.

the laparotomy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Laparoscopy; Laparotomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Qing Yang, M.D.

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangwei Wang, M.D.

CONTACT

+8618940228389; wanggw@sj-hospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 19, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2023
• Last Updated: February 19, 2016

Record last verified: 2016-02