Role of Laparoscopy in Assessing Resectability of Ovarian Cancer

NCT05564234 | Completed

• 1 other identifier: laparoscopy in ovarian cancer
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of Work is Prevention of unnecessary laparotomies and failed attempts to perform optimal cytoreduction in women with advanced ovarian cancer.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• complete gross resection of tumor

  The primary outcome for our study included improving complete gross resection rates at tumour cytoreductive surgery compared to historical data and avoids futile laparotomy defined as residual tumour with a maximum diameter more than 1 cm after primary cytoreductive surgery.

  baseline

Secondary Outcomes (2)

• Comparison between the accuracy of laparoscopy and CT with contrast on the abdomen

  baseline

• surgical morbidity.

  1 month

Study Arms (2)

Neoadjuvant chemotherapy

ACTIVE COMPARATOR

cases with predictive index value score 8 or greater in which primary cytoreductive surgery was not feasible were were referred for neoadjuvant chemotherapy then interval cytoreductive surgery was done

Procedure: laparoscopy then neoadjuvant chemotherapy followed by interval cytoreductive surgery

primary cytoreductive surgery

ACTIVE COMPARATOR

cases with predictive index value score less than 8 were offered primary cytoreductive surgery.

Procedure: laparoscopy then primary cytoreductive surgery

Interventions

laparoscopy then primary cytoreductive surgery PROCEDURE

Laparoscopy was used to calcautation of fagotti PIV score , if less than 8 primary cytoreductive surgery were done.

primary cytoreductive surgery

laparoscopy then neoadjuvant chemotherapy followed by interval cytoreductive surgery PROCEDURE

Laparoscopy was used to calcautation of fagotti PIV score and provides the histological diagnosis , if score more than 8 the patient were received neoadjuvant chemotherapy followed by interval cytoreductive surgery

Neoadjuvant chemotherapy

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with suspicious ovarian cancer by clinical and radiological assessment are included in this study.

You may not qualify if:

• Patients with poor Eastern Cooperative Oncology Group grade more than 2.
• Medical comorbidities at the time of diagnosis precluding primary surgery, newly diagnosed deep venous thrombosis or pulmonary embolus within 6 weeks of presentation.
• Immobile pelvic tumor reaching to xiphisternum leading to conclusions that complete cytoreductive surgery is not feasible
• Intrahepatic metastatic disease of more than one centimetre
• Para-aortic lymphadenopathy larger than one centimetre above the level of the renal veins
• Any contraindication for laparoscopy as cardiopulmonary compromise, intracranial diseases or large ventral hernia.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine, Zagazig Univeristy

Zagazig, Sharqia Province, 44511, Egypt

Location

Related Publications (3)

• Fagotti A, Ferrandina G, Fanfani F, Ercoli A, Lorusso D, Rossi M, Scambia G. A laparoscopy-based score to predict surgical outcome in patients with advanced ovarian carcinoma: a pilot study. Ann Surg Oncol. 2006 Aug;13(8):1156-61. doi: 10.1245/ASO.2006.08.021. Epub 2006 Jun 21.

  PMID: 16791447 BACKGROUND

• 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

• Fleming ND, Nick AM, Coleman RL, Westin SN, Ramirez PT, Soliman PT, Fellman B, Meyer LA, Schmeler KM, Lu KH, Sood AK. Laparoscopic Surgical Algorithm to Triage the Timing of Tumor Reductive Surgery in Advanced Ovarian Cancer. Obstet Gynecol. 2018 Sep;132(3):545-554. doi: 10.1097/AOG.0000000000002796.

  PMID: 30095787 BACKGROUND

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

• wael hu elbrombly, MD

  faculty of medicine,zagazig univeristy

  STUDY DIRECTOR

• hanan at ghaly, MD

  faculty of medicine,zagazig univeristy

  STUDY DIRECTOR

• mohamed ab lashin, MD

  faculty of medicine,zagazig univeristy

  STUDY DIRECTOR

• muhannad mo azab, Msc

  faculty of medicine,zagazig univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 3, 2022
• Study Start: December 9, 2019
• Primary Completion: December 9, 2021
• Study Completion: April 9, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

EG (1)