Testing two interventions to reduce the time needed to recover after surgery for ovarian cancer.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: This study involves randomly allocating participant into one of three study groups for the drink (intervention 1) and into one of two study groups for the pain medication tablet (intervention 2) as follows: Intervention 1: Drink 1: Carbo‐loading drink (400 ml, 50g carbohydrate) to be consumed within 5‐10 minutes, 2 hours before the operation Drink 2: Water (400ml, 0g carbohydrates) to be consumed within 5‐10 minutes, 2 hours before the operation Drink 3: No drink (0ml, 0g carbohydrates). Intervention 2: Tablet 1: 150 mg pregabalin tablet 1 hour before the operation and about 12 hours after the operation Tablet 2: Placebo tablet 1 hour before the operation and about 12 hours after the operation. A placebo is a medication with no active ingredients that is identical in appearance to the active medication. CONDITION: Cancer ‐ Ovarian and primary peritoneal Ovarian cancer; ; Ovarian cancer PRIMARY OUTCOME: To assess the feasibility of the study interventions by measuring adherence to allocated treatment via direct supervision. [For intervention 1 assessed at 2 hours prior to surgery and for intervention 2, 1 hour prior to surgery and then 12 hours following surgery. ] ; ; ; ; ] To measure the proportion of patients with aspiration pneumonitis, assessed by hospital records.[Assessed at the following time points: on patient anaesthetic bay check in, 2, 4, 8, and 12 hours (+/‐ 1 hour) following surgery, days 1, 2, 3‐7 (participants will be assessed on days 3 to 7 if they are still in hospital. In case of an earlier discharge than day 7, participants will only be assessed until the day of discharge).] To measure the proportion of patients with postoperative complications according to the Clavien Dindo classification within 30 days after surgery.[30 days after surgery of participant. ] To measure the proportion of patients with somnolence defined as a Ramsey sedation score of equal to or greater than 3, assessed by direct observation and recorded in the medical records.[Assessed at the following time points: on patient anaesthetic bay check in, 2, 4, 8, and 12 hours (+/‐ 1 hour) following surgery, days 1, 2, 3‐7 (participants will be assessed on days 3 to 7 if they are still in hospital. In case of an earlier discharge than day 7, participants will only be assessed until the day of discharge). ] To measure the time from the end of surgery until first bowel motion other than gas, assessed using a patient diary.[Assessed at the following time points: 2, 4, 8, and 12 hours (+/‐ 1 hour) following surgery, days 1, 2, 3‐7 (participants will be assessed on days 3 to 7 if they are still in hospital. In case of an earlier discharge than day 7, participants will only be assessed until the day of discharge). ; ; ] To measure the time from the end of surgery until first tolerance of regular intake of solid food (min 3 times daily) without vomiting or discomfort, assessed using a patient diary.[Assessed at the following time points: 2, 4, 8, and 12 hours (+/‐ 1 hour) following surgery, days 1, 2, 3‐7 (participants will be assessed on days 3 to 7 if they are still in hospital. In case of an earlier discharge than day 7, participants will only be assessed until the day of discharge). ; INCLUSION CRITERIA: 1. Women aged 18 and older with suspected advanced malignancy of the ovary/fallopian tube or peritoneum. 2. Disease suspected to be at least Stage III disease at initial diagnosis. 3. Planned to undergo laparotomy (primary surgery or after neoadjuvant chemotherapy of a maximum 4 cycles of chemotherapy). 4. Adequate renal function (e.g. creatinine clearance greater than 50 ml/min). 5. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. SECONDARY OUTCOME: To assess pain over the first 48 hours after surgery (at 2, 4, 8, 12, 24 and 48 hours post‐operatively), using patient questionnaire "assessment of current pain" tool. [48 hours post surgery of last randomised participant.] To assess the acceptability of the pregabalin, assessed by documenting whether or not the patient took the pregabalin tablet.[Assessed immediately after taking.] To assess the amount of morphine equivalents during the first 48 hours post‐operatively. Assessed by completing the "Discharge Measure Study Aid" and review of medical records at patient discharge.[48 hours post surgery of participant.] To assess the composite incidence of hunger, thirst, nausea, fatigue, drowsiness, trouble concentrating, diarrhoea, constipation, bloating, and aspects of well‐being, collected using the measures of advanced ovarian cancer patients’ perioperative symptoms (MAPS) instrument.[Completed at screening (0‐28 days prior to randomisation), within 1‐2 hours before surgery, and between 6‐9am on days 1, 2, 3 ‐7 (participants will be assessed on days 3 to 7 if they are still in hospital. In case of an earlier discharge than day 7, participants will only be assessed until the day of discharge).] To assess the palatability of the carbohydrate drink, assessed by asking participants to assess the taste of the drink immediately after drinking. Patients who did not receive a drink will still complete the drink assessment questionnaire. The questionnaire was designed specifically for this study.[Assessed immediately after drinking.] To measure death from any cause within 30 days after surgery.[30 days after surgery participant. ] To measure the number of days at home (or rehabilitation facility) within 30 days after surgery, assessed via review of hospital records and a phone call to the participant. [30 days after surgery of participant. ] To measure the proportion of patients who are re‐admitted to hospital within 30 days after surgery, assessed via review of hospital records and a phone call to the participant.[30 days after surgery of participant. ] To measure the proportion of patients who experience vomiting within 1 hour after CHO/control drink administration, assessed by direct observation, completion the "Discharge Measure Study Aid" and review of medical records.[For intervention 1, assessed at 1 hour prior to surgery (1 hour following drink administration). ; ] To measure the time from the end of surgery until first use of rescue analgesia defined as first press of Patient Controlled Analgesia (PCA) or bolus if Epidural anaesthesia (EDA) is used. Assessed by completing the "Discharge Measure Study Aid" and review of medical records at patient discharge.[Until participant is discharged from hospital following surgery.] To measure time from admission to discharge from hospital, assessed by completing the "Discharge Measure Study Aid" and review of medical records at patient discharge.[When participant is discharged from hospital.] 6. Signed, written informed consent.
Epistemonikos ID: 6ba553118ec57007b830a1dbf54f2822434a3a5f
First added on: Aug 24, 2024