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

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.