Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.

NCT03798132 | Unknown FDA Device

• 1 other identifier: SouthECI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.

Conditions

Peritoneal Carcinomatosis

Keywords

Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures.

Outcome Measures

Primary Outcomes (1)

• peritoneal carcinomatosis

  Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.

  one year

Secondary Outcomes (1)

• surgical decision making.

  one year

Interventions

laparoscopy DIAGNOSTIC_TEST

evaluation of peritoneal carcinomatosis by laparoscopy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent preoperative CT and diagnostic laparoscopy

Sponsors & Collaborators

• Shimaa Abdalla Ahmed: lead

Study Sites (1)

South Egypt Cancer Institute

Asyut, 11517, Egypt

RECRUITING

Related Publications (1)

• Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.

  PMID: 18801470 BACKGROUND

MeSH Terms

Conditions

Peritoneal Neoplasms; Ovarian Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland 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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of radiodiagnosis

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: January 1, 2019
• Primary Completion: June 11, 2019
• Study Completion: December 1, 2020
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

EG (1)