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Quality of Life After Esophagectomy for Cancer - QOLEC1: A Randomized Controlled Trial on Psychological Support and Sleep Adjuvant Devices in Esophagectomy Postoperative Management
Marco Scarpa*1, Eleonora Pinto1, Elisabetta Saraceni2, Francesco Cavallin1, Matteo Parotto3, Rita Alfieri1, Mariateresa Nardi5, Rita Marchi4, Matteo Cagol1, Cristina Caberlotto1, Luca Maria Saadeh1, lorenza caregaro3, Andrea Vianello4, Fabio Baratto4, Carlo Castoro1
1Oncological Surgery Unit, Regional Centre for Oesophageal Disease, Veneto Institute of Oncology (IOV-IRCCS), Padova, Italy; 2ICU Anesthesia Department, Azienda Ospedaliera di Padova, Padova, Italy; 3University of Padua, Padova, Italy; 4Azienda Ospedaliera of Padova, Padova, Italy; 5Veneto Institute of Oncology, Padova, Italy
Background:
Postoperative management of patients undergoing esophagectomy is particularly challenging because of the risk of severe postoperative complications; moreover, postoperative pain can heavily affect postoperative quality of life. The permanence in ICU (where noise and full light are almost constant), the use of vasopressors, painful stimuli, a nasogastric tube kept in place for the first postoperative days cause constant discomfort that can produce sleep disturbance that can affect postoperative quality of life and clinical course.
The aims of this randomized controlled trial were to assess the effectiveness of psychological counselling and isolation devices to improve the quality of postoperative sleep.
Patients and methods:
Patients will be randomized into four groups receiving respectively: psychological counselling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counselling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. Quality of life and quality of sleep were measured preoperatively and at 14 days (average time to hospital discharge with EORTC QLQ-C30, OES-18, and Pittsburgh Sleep Quality Index. The primary end point are the items QL2 (Global Quality of Life) and SL (Sleep Disorder) of the QLQ-C30, and the secondary end point is the score of the PSQI. Non parametric statistics was used.
Results:
Patients in the 4 groups were comparable regarding demographic and clinical characteristics. Global quality of life (C30-QL) impairment after surgery was reduced by psychological support (p=0.02), even after adjusting for postoperative morbidity (p=0.04). Overall, 50% patients referred sleep disorder (C30-SL), with similar rates in the 4 groups (p=0.92). However, psychological support with isolation devices reduced the proportion of patients reporting postoperative impairment of global sleep quality (p=0.004) and of sleep duration (p=0.002). Mean use of hypnotic drugs was 5 days (SD 5) on a mean length of stay of 17.1 days (SD 5.3) and was affected by psychological support with isolation devices (p=0.02).
Conclusions:
Perioperative psychological support improves global quality of life, even after adjusting for postoperative morbidity. Psychological support with isolation devices reduces the proportion of patients reporting postoperative impairment of global sleep quality and of sleep duration as well as the use of hypnotic drugs during the postoperative hospital stay.
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