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A Study to find role of laparoscopy to detect inoperable disease with minimal invasive technique so that an unsuccessful laparotomy can be avoided.

Validation of a laparoscopy based score for predicting surgical outcome in patients undergoing interval debulking for advanced ovarian carcinoma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/05/004585
Enrollment
68
Registered
2014-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Epithelial carcinoma ovary FIGO stage III and Stage IV post neoadjuvant chemotherapy

Interventions

Intervention1: Diagnostic laparoscopy in patient undergoing interval cytoreduction for carcinoma ovary: Validation of laparoscopy based model developed by Faggoti A et al (2006) to predict optimal cy

Sponsors

Regional cancer centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient must be under 75 years of age. 2. Patient must have Stage III ovarian cancer by pre operative CT imaging . 3. Patient must have a WHO performance score of 0 â?? 2. 4. Patient must have an ASA (American Society of Anesthesiologists physical status classification system) score of 1-2. 5. The absence of serious disabling diseases that would contraindicate a laparoscopy

Exclusion criteria

Exclusion criteria: 1. Extensive peritoneal and bowel carcinomatosis 2. Age more than 75 years 3. Nonepithelial ovarian cancers and borderline tumours. 4. ASA score of 3 or more 5. ECOG performance status of >= 3. 6. Laparoscopy not possible for technical reason e.g. large mass filling whole abdomen, prior multiple surgeries.

Design outcomes

Primary

MeasureTime frame
Validation of laparoscopy based model developed by Faggoti A et al (2006) to predict optimal cytoreduction in interval debulkingTimepoint: Observations noted during surgery and during hospitalisation ,Up to 5 days Post operative .

Secondary

MeasureTime frame
Comparison of test performance of PIV in our population and in Faggotiâ??s populationTimepoint: Observations noted during surgery and during hospitalisation ,Up to 5 days Post operative .;Percent of patient undergoing optimum cytoreductionTimepoint: Observations noted during surgery and during hospitalisation ,Up to 5 days Post operative .;Percent of patient with complete cytoreductionTimepoint: Observations noted during surgery and during hospitalisation ,Up to 5 days Post operative .;Performance of each individual predictive score in our populationTimepoint: Observations noted during surgery and during hospitalisation ,Up to 5 days Post operative .;Test performance of laparoscopy based score to predict inoperability in terms of sensitivity, specificity, PPV and NPV in Interval cytoreduction cases .Timepoint: Observations noted during surgery and during hospitalisation ,Up to 5 days Post operative .

Countries

India

Contacts

Public ContactDr Than Singh Tomar

Regional cancer centre, Thiruvananthapuram

thansinghtomar111@gmail.com9567172102

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026