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Role of lymph node removal during surgery in patients with advanced stage carcinoma ovary post chemotherapy

Comparison between routine and selective lymphadenectomy during optimally debulked interval cytoreductive surgery in patients with advanced stage carcinoma ovary post neoadjuvant chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024545
Enrollment
40
Registered
2020-04-09
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: C569- Malignant neoplasm of unspecifiedovary

Interventions

Intervention1: Routine lymphadenectomy: Retro peritoneal lymphadenectomy irrespective of size of lymph node Control Intervention1: Selective lymphadenectomy: Removal of enlarged retro peritoneal lymph

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with stage III and IV epithelial ovarian carcinoma receiving 3-4 cycles of neoadjuvant chemotherapy with Paclitaxel and Carboplatin. 2. Patients with stage II disease with significant bladder and rectal infiltration and who will refuse major urinary and bowel resection anastomosis. 3. Intraoperative completely resected disease. 4. Women less than 75 years of age. 5. Women with ECOG status 0-2.

Exclusion criteria

Exclusion criteria: 1. Women more than 75 years. 2. Women with any other cancer associated with carcinoma ovary. 3. Any relative contraindication for extensive surgery such as cardiac disease, renal disease, increased bleeding diathesis. 4. Poor functional status ECOG more than 2. 5. Any prior retroperitoneal surgery.

Design outcomes

Primary

MeasureTime frame
1.Total operative duration, intraoperative complications and interventions. 2.Blood loss. 3.Patientsâ?? early complications by the modified Clavien -Dindo classification system. 4. Early post-operative recovery parameters like intensive care unit stay, time to bowel activity, hospital stay. 5.Total number of lymph node yield and number of positive nodes will be studied. 6.Overall survival, recurrence free survival, pattern of recurrence. Timepoint: 4 weeks after surgery 6 months post treatment—

Secondary

MeasureTime frame
Overall survival, recurrence free survival, pattern of recurrence. Timepoint: 6 MONTHS 12 MONTHS—

Countries

India

Contacts

Public ContactSANDIPAN CHOWDHURI

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH

jaya_sunil@yahoo.com9997310120

Outcome results

None listed

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