Intra-operative Visual Examination at IDS

NCT04444934 | Completed

• 1 other identifier: DIPUSVSP-03-02-2033
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Complete disease removal has the greatest impact in the treatment of advanced ovarian cancer, both during primary debulking surgery (PDS) and interval debulking surgery (IDS), but, contrarily to PDS, no consensus exist on the interpretation of the absence of residual tumor at IDS. In addition, chemotherapy induces fibrotic changes that can hinder the surgeon's ability to properly assess the spread of abdominal disease. The aim of the study is to evaluate the accuracy of visual inspection compared to histopathological examination at the level of the diaphragmatic peritoneum in patients undergoing surgery after neoadjuvant chemotherapy.

Conditions

Diaphragm Disease

Keywords

ovarian cancer; interval debulking surgery; visual examination

Outcome Measures

Primary Outcomes (1)

• Accuracy

  to evaluate the accuracy of the visual examination compared to histopathological examination, at the level of the right diaphragmatic peritoneum, in patients subjected to IDS

  During surgery

Secondary Outcomes (1)

• Post-operative complications

  up to 30 days after surgery

Study Arms (2)

Patients with not-surely pathologic diaphragmatic peritoneum

The definition of not-surely pathologic diaphragmatic peritoneum was given in association with the presence of flat dyschromic areas.

Other: histological examination

Patients with certainly pathologic diaphragmatic peritoneum

The definition of certainly pathological diaphragmatic peritoneum was given when isolated or confluent thick nodules were visualized at the intra-operative inspection.

Other: histological examination

Interventions

histological examination OTHER

Patients were classified in two groups based on the surgeon's visual examination of the right diaphragmatic peritoneum. The accuracy of visual examination has been assessed comparing surgeon's opinions to histological examination

Patients with certainly pathologic diaphragmatic peritoneum; Patients with not-surely pathologic diaphragmatic peritoneum

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histology proven biopsy of epithelial ovarian, fallopian or peritoneal cancer (FIGO stage III C - IV B), judged suitable for IDS by clinicians, with evidence of suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at intraoperative evaluation.

You may qualify if:

• patients with histology proven biopsy of epithelial ovarian, fallopian or peritoneal cancer (FIGO stage III C - IV B), judged suitable for IDS by clinicians, with evidence of suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at intraoperative evaluation.

You may not qualify if:

• Patients with no evidence of diaphragmatic disease during IDS, and who therefore did not undergo diaphragmatic peritonectomy or biopsy

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

• Barbara Costantini, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 24, 2020
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

IT (1)