Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function (NCT03887845) | Clinical Trial Compass
CompletedNot Applicable
Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function
China401 participantsStarted 2018-08-01
Plain-language summary
A prospective study to compare the postoperative ileus in open and laparoscopic gastrointestinal surgery through the determination of the time the patient takes to pass flatus, pass stool, bowel movement, oral intake, the time of hospital stay and total hospital costs. Postoperative ileus (POI) is one of the major focus of concern for surgeons, hospital executives, quality assurance directors as well as patients because of its role in causing patient distress, discomfort, and morbidity, leading to an increase in the duration of hospital stay and cost of care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged ≥18 years scheduled to undergo elective abdominal surgery
* American Society of Anesthesiologist (ASA) grade ≤ III
* Alert consciousness
* Any BMI
* Accurate preoperative diagnosis on the basis of necessary reports
Exclusion Criteria:
* Cannot participate in study assessments owing to the language barrier, dementia or postoperative delirium
* Previously received palliative surgery
* Develops early postoperative bowel obstruction, Anastomotic leakage or Gastroparesis
* Those requiring reoperation for any other indication before the commencement of formal assessment for POI
* Those requiring more than 30 minutes of adhesiolysis
* Emergency cases
* American Society Anesthesia (ASA) class IV or V patients, pregnancy, patient with abdominal carcinomatosis or radiation enteritis, inoperable cases due to metastasis, patients simultaneously enrolled in any other competing for clinical study and violation of study protocol by the patient or patient care team
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared open versus laparoscopic gastrointestinal surgery specifically by tracking how long it took patients to pass gas after the operation — what did results like these actually mean for recovery time, and would the type of surgery I'm having be expected to affect how quickly my gut wakes up afterward?
2Since this trial is now completed and was measuring postoperative ileus — the gut 'going to sleep' after surgery — have the findings changed how you would recommend managing or preventing that complication in my case?
3The trial tracked length of hospital stay as a key outcome — based on what studies like this have found, what's a realistic expectation for how long I might be in hospital after open versus laparoscopic surgery, and which approach are you recommending for me?
4Postoperative ileus can be really uncomfortable and slow down recovery — are there specific steps my care team would take before, during, or after my surgery to reduce the chances of it happening, and does evidence from research like this inform that plan?
5Since this trial was observational in nature rather than testing a new drug or device, does it provide strong enough evidence to influence my surgical plan, or are there other studies you'd point me to when weighing the pros and cons of open versus laparoscopic surgery for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.