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Clinical Trials/NCT02686463
NCT02686463UnknownNot Applicable

Diagnosis and Treatment of Laparoscopy for Malignant Ovarian Cancer: an Open-label, Parallel, Randomized, Controlled Clinical Trial of Efficacy and Safety

Shengjing Hospital0 sites150 target enrollmentStarted: April 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Primary Endpoint
Progression free survival

Study Overview

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.

Detailed Description

The principle for treating early-stage ovarian cancer is first to stage the cancer, and then to determine the optimal surgical and non-surgical treatments. Ovarian cancers mainly metastasize as extensive diffusions on surfaces of organs in the abdominal cavity. Although the most common ovarian cancer staging method is laparotomy, this procedure often misses upper abdominal metastases, especially on the diaphragm muscles, thus leading to inaccurate staging and prognostic assessments, and insufficient treatment.

A laparoscopic approach allows closer observation of relevant tissues, as these tissues are magnified in laparoscopies, which facilitates discovery of small lesions on surfaces of diaphragmatic muscle, liver and stomach fundus. Laparoscopes allow lavage of a wider area of the abdominal cavity, including hepatic flexure, splenic flexure and diaphragmatic muscle; and can also improve the accuracy of peritoneal lavage examinations while avoiding blood contamination. Laparoscopic surgery is also a very accurate staging procedure, with potentially reduced complications, bleeding, hospitalization days and expense, and recovery time compared with laparotomy-thus shortening the interval between surgery and initiation of postoperative adjuvant chemotherapy.

However, although some studies have compared laparoscopy and laparotomy for ovarian cancer, most are individual or small-sample case report or case-control studies. A prospective randomized controlled clinical trial is needed.

This will be a prospective, open, parallel, randomized, controlled clinical trial, designed to compare the advantages and disadvantages of laparoscopy and laparotomy in diagnosing and treating early malignant ovarian cancer in terms of surgical safety, postoperative survival rate, reoperation rate, postoperative quality of life and medical cost, to provide evidence for clinical application of laparoscopic surgical staging in in diagnosing and treating early malignant ovarian cancer, and to fill some gaps in the evidence for laparoscopy versus laparotomy. Endoscopic surgical staging of early malignant ovarian cancer accords with the trend of minimal invasion and radical treatment for tumors.

Surgical procedures Laparoscopy: (1) Pneumoperitoneum will be established for laparoscopy. Ascites or pelvic peritoneal lavage fluid will be used for cytologic examination. (2) Unilateral or bilateral attachments will be resected, placed in specimen bags, and removed, to be pathologically examined as fast-frozen samples. Alternatively, the ovarian artery and vein will be ligated, and attachments on the lesion side will be resected and placed in the specimen bag, which will be tied and placed at right iliac fossa. (3) The uterus will be resected and removed through the vagina with the specimen bag at the right iliac fossa. (4) Pelvic and para-aortic lymph nodes will be resected and separately removed through the vagina. (5) The greater omentum below the transverse colon will be resected and, together with parietal peritoneum at the paracolic sulci and basin side, receive multiple punch biopsies. (6) Removal of vermiform appendix; closure of vaginal stump by vaginal suture and laparoscopic suspension; (7) wound hemostasis, irrigation, and drainage.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Progression free survival

Time Frame: 5 years

Time to recurrence

Secondary Outcomes

  • Operative complication rate(30 days)
  • Overall survival(5 years)
  • Quality of life after surgery(Baseline, 1 week, 1 month, 3 months and 1 year after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Qing Yang

Vice President

Shengjing Hospital

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