Concordance Between Radiologic Laparoscopic and Laparotomic Evaluation for Complete Cytoreduction of Ovarian Masses

NCT07416435 | Not Yet Recruiting

• 1 other identifier: laparoscopic and laparotomicOM
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ovarian mass occur in women of all ages, and their etiology and frequency range age accordingly. The ovarian mass may come from functional or physiological changes, inflammatory processes, endometriosis, benign and malignant tumor(1). Ovarian cancer (OC), the most lethal gynecological malignancy, usually presents in advanced stages. Characterized by peritoneal and lymphatic dissemination, OC necessitates a complex surgical approach usually involving the upper abdomen with the aim of achieving optimal cytoreduction without visible macroscopic disease (R0)(2). The presence of a residual tumor at the end of surgery is indeed recognized as the main negative prognostic factor for patients with AOC. In this context, complete cytoreductive surgery (R0) achieving no gross residual disease is associated with the best survival outcomes(3). Despite the increasing adoption of diagnostic laparoscopy, laparotomic assessment during definitive cytoreductive surgery remains the gold standard for evaluating the true extent of disease and determining resectability(4). Over the years, different score systems have been proposed and evaluated, aiming to assess the peritoneal spread of the disease and predict whether it is possible to obtain R0. Several imaging-based scoring models, using computed tomography (CT), have been suggested to predict the outcomes of PDS. These models included different radiological criteria, such as peritoneal thickening, ascites, para-aortic lymphadenopathy, and bowel involvement. Although the overall good predictive performance, the main limitation is represented by the unsuccessful rate when cross-validations datasets were used(3). Staging laparoscopy has shown to be a minimally invasive tool able to properly drive the therapeutic choice between primary cytoreductive surgery and neoadjuvant chemotherapy. To quickly select candidates for upfront surgery, and to decrease the delay to cytoreductive surgery or neoadjuvant chemotherapy, we offer patients a two-step surgical management protocol in which diagnostic laparoscopy is performed a few weeks prior to cytoreductive surgery(5). a laparoscopic scoring algorithm (predictive index, (PI) which developed by Fagotti et al.2015 including seven parameters based on intra-abdominal distribution of the disease. Although the accuracy of the laparoscopic model is 75% at predicting surgical outcome, the percentage of unnecessary laparotomies remains 33%, even after the inclusion of upper abdominal surgical score. Moreover, concordance between PI scores and PDS varies by anatomical location, with the lowest concordance in predicting bowel infiltration(6).

Conditions

Ovarian Mass

Outcome Measures

Primary Outcomes (1)

• Surgical complexity

  Surgical complexity will be graded as low (≤3), intermediate (4-7), and high (≥8).

  baseline

Study Arms (1)

Patients with ovarian mass who are candidates for primary debulking surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary ovarian cancer patients with no extraperitoneal metastatic disease and candidates for primary debulking surgery

You may qualify if:

• women aged \>18 years
• patients with primary ovarian cancer eligible for CRS
• primary ovarian cancer patients with no extraperitoneal metastatic disease

You may not qualify if:

• patients with significant comorbidities (hepatic or renal failure, severe cardiovascular or pulmonary patients with hepatic metastases
• newly diagnosed pulmonary embolism.
• criteria set by Aletti and colleagues (age \>75 years, serum albumin 3.0 g/dL, and American Society of Anesthesiologists classification score ≥3 or extensive disease).
• Unresectable stage IVB disease found on preoperative imaging which defined as multiple parenchymal liver metastases, pulmonary metastases including diffuse pleural involvement, brain metastases, or bulky thoracic adenopathy (not including anterior, lateral, or posterior cardiophrenic lymphade nopathy).
• Patients who received initial treatment elsewhere or is known non-epithelial ovarian carcinoma histology on pathology
• patients refused to participate in study

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02