Authors
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Kathopoulis, Nikolaos -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2017
INTERVENTION: 150 participants will be randomised to six groups prior to laparoscopic surgery using a six‐subject computer generated blocked randomisation scheme. A third party research assistant not involved in patient recruitment or data collection will give a written preoperative dietary instruction sheet according to the allocated group of each patient. The surgeons will not be aware of the group that each patient is allocated to. Group A1: Patients with no preoperative bowel preparation only liquid diet for 24 hours prior to laparoscopy and fasting for 8 hours prior to the operation. The usual moderate neuromuscular blockade was applied during all the duration of laparoscopy, from the time that the patient was anesthetized until the anesthesia has finished. Group B1: Mechanical bowel preparation with 2 sachets of oral laxative (59g/sach of Polyethylene Glycol, 0,7425g/sach of Potassium chloride, 1,465g/sach of Sodium chloride, 1,685g/sach of Sodium bicarbonate) diluted in 1,5 litter of water and ingested 24 hours prior to laparoscopy. The usual moderate neuromuscular blockade was applied during all the duration of laparoscopy, from the time that the patient was anesthetized until the anesthesia has finished. Group C1: Patients were on a minimal residue diet for 3 days prior to laparoscopy and fasting for the last 8 hours prior to the operation. The usual moderate neuromuscular blockade was applied during all the duration of laparoscopy, from the time that the patient was anesthetized until the anesthesia has finished.. Group A2: Patients with no preoperative bowel preparation only liquid diet for 24 hours prior to laparoscopy and fasting for 8 hours prior to the operation. Deep neuromuscular blockade was applied as a muscle relaxation method during all the duration of laparoscopy, from the time that the patient was anesthetized until the anesthesia has finished. Group B2: Mechanical bowel preparation with 2 sachets of oral laxative ( 59g/sach of Polyethylene Glycol, 0, CONDITION: Bowel preparation and deep neuromuscular blockade in gynecological laparosocopic operations ; Surgery PRIMARY OUTCOME: 1. Surgical field quality, measured with a 4‐point VAS (0 very poor, 1 poor, 2 good, 3 very good) 15 minutes after the entrance of the central trocar; 2. Postoperative pain, measured with a 5‐point VAS (0 no pain, 4 severe pain) 12 hours after the operation completion INCLUSION CRITERIA: 1. Female patients 2. Aged over 18 years old 3. Patients with indication of laparoscopic gynaecological operation 4. Patients that may communicate sufficiently with the researcher 5. Patients that have signed an informed consent for their participation on the present study 6. Patients ASA class I‐II 7. Patients with known allergy to Polyethylene Glycol (PEG) SECONDARY OUTCOME: 1. Symptoms measured with a 5‐point VAS from the time the bowel preparation is applied until just before the patient’s transportation from the room to the operation table:; 1.1. Insomnia; 1.2. Tiredness; 1.3. Bloating; 1.4. Abdominal cramps or pain; 1.5. Nausea; 1.6. Vomiting; 1.7. Anal irritation; 1.8. Weakness; 1.9. Chest pain; 1.10. Hanger pain; 1.11. Thirst; 2. Patient compliance with the completion of the bowel preparation, measured with questionnaire just before the patient’s transportation from the room to the operation table; 3. Patient opinion of the method of bowel preparation used, measured with questionnaire just before the patient’s transportation from the room to the operation table; 4. Ease of completion of the preparation, measured with questionnaire just before the patient’s transportation from the room to the operation table; 5. Postoperative symptoms and bowel function; 5.1. Bloating, measured with a 5‐point VAS 24 hours after the operation completion; 5.2. Nausea, measured with a 5‐point VAS 24 hours after the operation completion; 5.3. Time of first gas passing after the operation, assessed by interview on the 3rd postoperative day; 5.4. Time of first stool passing after the operation, assessed by interview on the 3rd postoperative day; 6. Hospital stay (the number of postoperative days the patient stayed in the hospital); 7. Intraoperative complications during the length of the laparoscopic operation ; 7.1. Subcutaneous emphysema from the time the patient was anesthetized until recovered from the anesthesia; 8. Postoperative complications, recorded with an interview with the patient 1 month after the operation; 9. Hematocrit changes, measured from 24 hours before the operation and the 2nd postoperative day
Epistemonikos ID: fd68c365306060da938df862ece75c06655711f6
First added on: Aug 23, 2024