How bowel preparation and deep neuromuscular blockade may affect field visualization and postoperative pain in patients undergoing gynecological laparoscopic surgery

Surgical and patient outcomes using bowel preparation and deep neuromuscular blockade before laparoscopic gynecologic surgery: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59502124

Enrollment

150

Registered

2017-08-30

Start date

2017-09-01

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel preparation and deep neuromuscular blockade in gynecological laparosocopic operations Surgery

Interventions

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 pa

Eligibility

Sex/Gender

Female

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: 1. Age under 18 years old 2. Male patients 3. Patients with known gynecological cancer 4. Patients with irritable bowel syndrome 5. Patients with hepatic of renal failure 6. Laparoscopy converted to laparotomy 7. Patients ASA class III-VI

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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 operat	—

Measure

Time frame

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 operat

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Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026