Study Design : Prospective observational study

Setting : Department of Obstetrics and Gynaecology (Gynaecologic Oncology) , All India Institute of Medical Sciences, Delhi and Department of Gynae Oncology NCI Jhajjar

Ethical Clearance: Institute Ethics committee of All India Institute of Medical Sciences.

Work plan:

Selection of the study population

• The study will be started after approval by the Institute Ethics committee.

• Women attending the Gynaecology OPD in the Department of Obstetrics and Gynaecology at All India Institute of Medical Sciences, Delhi and NCI Jhajjar will be screened and evaluated.

• For cervical, endometrial, and vulvar histopathological proven cases admitted for surgery will be recruited.

• For ovarian malignancies, patients planned for primary/interval CRS as well as suspicious adnexal masses will be recruited.

  Consent

  After explaining the study protocol, a copy of the Patient Information Sheet will be provided and informed written consent will be taken.

  Patient selection criteria

  Inclusion criteria

• Histologically proven gynaecological malignancies (endometrial cancer, cervical cancer and vulvar cancer) of age 60 and above

• Ovarian malignancy planned for Primary/Interval cytoreduction

• Patients with suspicious ovarian masses planned for hysterectomy and/or salpingo-ophorectomy

  of age 60 and above

• Patient willing to give consent for participation in study

  Exclusion criteria

• Advanced inoperable malignancy

• Prior history of surgery or radiotherapy for genital malignancy

• Recurrent malignancy

  Sample size

  Since there is no such study in Indian population, a sample of convenience i.e. 150 elderly patients will be recruited over 24 months

  Study Scheme

  Once the patient meets the inclusion/exclusion criteria and gives informed written consent, she will be enrolled in the study. After enrolment, detailed history followed by a physical examination, including a general and systemic examination will be done. Local examination shall include abdominal examination, speculum examination, bimanual pelvic and rectal examination. Patient will then undergo routine and disease specific investigations.

  Investigations

  All enrolled patients will undergo routine investigations including hemogram, liver function test, kidney function test, chest X-ray, electrocardiogram, viral markers (HIV, HBsAg, anti HCV), blood sugar- fasting/postprandial, stool for occult blood and tumour markers. Appropriate imaging will be done as indicated (USG, CEMRI abdomen + pelvis, CECT thorax + abdomen + pelvis, PET CT). Mammogram, Upper GI endoscopy, and Lower GI endoscopy will be done as indicated.

  Assessment of FRAILITY

  In our cohort, frailty will be assessed using the G8 questionnaire and the FRAIL Scale. The G8 questionnaire of 7 queried items, such as nutrition status and amount of medication taken on a daily basis. The maximum achievable score is 17 points; a total score of ≤14 of defines patients as frail. Neuropsychological problems will be assessed using Geriatric Depression Scale 15 (GSD 15) and Montreal Cognitive Assessment (MoCA).

  The FRAIL Scale consists of five items, including fatigue, illness, ambulation, resistance and loss of weight. Each question corresponds to one item and is scored as 0 or 1 points. Patients are defined as robust only at a score of 0. Pre-frail patients score 1–2 points, and frail at a score ≥ 3 points.

  All recruited patients will receive routine standard care as per hospital protocol i.e. high protein diet, incentive spirometry, daily walk at least 30 minutes and vitamins and calcium supplementation.

  Surgical procedure

  Complete surgical procedure will be carried out specific to each malignancy in both the groups
  Details of surgical procedure and intraoperative findings including duration of surgery, intraoperative blood loss, number and details of transfusion, completeness of cytoreduction (CC) score, peritoneal carcinomatosis index, surgical complexity score and details of residual disease, ICU stay and intraoperative complications will be noted

  Final histopathology details including FIGO stage, LN metastasis, histological subtype, and histological grade will be noted

  Assessment of postoperative complications

  Postoperative complications will be observed during a period of 30 days after surgery and classified using the well-established and commonly used Clavien–Dindo classification system.

  Major complication will be classified as Clavien-Dindo grade ≥ II including complications requiring pharmacological treatment with drugs other than such allowed for grade 1 complications; blood transfusion and total parenteral nutrition are also included (grade 2 ) complications requiring surgical, endoscopic or radiological intervention (grade three), life-threatening complications requiring Intensive Care management (grade four), and death of a patient (grade five). Complications grade I will be considered as minor complication. In minor complications, occurrence of delirium will also be focussed. Delirium will be said to occur when its presence is described in the medical record and/or antipsychotics are prescribed.

  Besides data on 30-days postoperative complications, we will collect data about the postoperative hospital stay (defined as the number of postoperative days spent in hospital until discharge) and the rate of unplanned readmissions.

  OUTCOME MEASURES

  Primary outcomes

  To assess the association between preoperative frailty assessment using G8 geriatric screening tool and FRAIL scale with postoperative complications as measured using Clavein-Dindo classification.

  Secondary outcomes

  • To assess the correlation of frailty with tumour markers, performance status, duration of surgery, intraoperative blood loss, FIGO stage, histological subtype, histological grade, residual tumour burden, LN metastasis, duration of hospital stay and rate of unplanned readmissions

  • To assess the correlation of depression and cognition using assessed using GSD 15 and MoCA with postoperative complications as measured using Clavein-Dindo classification.