Preop Laxatives in Robotic Urologic Surgery

Официальное название

The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery

Обзор

Minimally-invasive surgery, either laparoscopic or robotic, is commonly used in urology. Several urologic procedures including prostatectomy, radical nephrectomy, and partial nephrectomy are now commonly performed robotically. Patients undergoing these procedures often have delayed return of bowel function and persistent gastrointestinal symptoms including nausea/vomiting, abdominal distension, and bloating for several days to weeks after surgery. Postoperative stool softeners and laxatives are routinely used in an effort to minimize these symptoms, with varying degrees of success. The aim of this study will be to evaluate whether the use of a preoperative osmotic laxative will be beneficial in improving recovery of bowel function and alleviating postoperative gastrointestinal complaints in patients undergoing these procedures. Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery. Patients in both groups will receive the same postoperative bowel regimen including scheduled PEG both in the hospital and upon discharge until first bowel movement. Patients will be given a questionnaire and diary to record their postoperative gastrointestinal symptoms and time to first bowel movement. These questionnaires and diaries will then be analyzed to determine differences in time to first bowel movement and gastrointestinal complaints during their recovery from surgery.

Вмешательства

• Препарат Polyethylene Glycol 3350
  Patients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not.

Первичные конечные точки

• Time to first bowel movement after surgery [Срок оценки: 7 days]

Вторичные конечные точки (2)

• Narcotic usage [Срок оценки: 7 days]
• Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire [Срок оценки: 7 days]

Критерии участия

Критерии включения

-Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy

Критерии исключения

• Patients under 30 years old
• Patients with a contraindication to receiving polyethylene glycol or other forms of laxatives
• People who regularly take Miralax
• Patients undergoing retroperitoneal radical or partial nephrectomy
• Patients with severe ulcerative colitis or Crohn's disease
• Patients with intestinal diversions (colostomy, ileostomy)
• Patients with prior abdominal or pelvic radiation
• Patients who will not follow up with UIHC postoperatively
• Patients who are incarcerated

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Iowa Hospitals & Clinics — Iowa City

Идентификаторы

NCT: NCT05805436 · 202209015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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