Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

Study Overview
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Brief Summary
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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.

Detailed Description
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All patients aged ≥18 years scheduled to undergo gastric and colorectal cancer resection surgery at the Department of Gastrointestinal Surgery, West China Hospital between 2019 to 2020 will be screened for eligibility. The inclusion criteria for the study will be the patient undergoing elective gastric cancer surgery, have the American Society of Anesthesiologist (ASA) grade ≤ III, alert consciousness, and BMI, and accurate preoperative diagnosis of gastric adenocarcinoma on the basis of computed tomography CT scan report, Gastroscopy and Histopathological reports. Exclusion criteria will be those who 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 PPOI. Those requiring more than 30 minutes of adhesiolysis. Each patient will be approached during preoperative counseling on an individual basis by one of the authors (YZ)

Official Title
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A Prospective Case-control Study Comparing the Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open gastrointestinal surgery<br>All patients enrolled in this group would undergo open gastric and colorectal resection surgery. | Procedure: Surgery<br>* The respective surgical approach for any gastric and colorectal surgery<br>|
| Laparoscopic gastrointestinal surgery<br>All patients enrolled in this group would undergo laparoscopic gastric and colorectal resection surgery. | Procedure: Surgery<br>* The respective surgical approach for any gastric and colorectal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first flatus | The time between end of surgery and passage of first flatus | up to 1-4 Days after surgery | 
| Length of hospital stay | The time between end of surgery and written discharge ticket | up to 1-10 Days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first bowel movement | The time between end of surgery and first bowel movement | up to 1-6 Days after surgery | 
| Time to first oral intake | The time between end of surgery and first oral intake >25% than usual intake | up to 1-6 Days after surgery | 
| Time to first defecation | The time between end of surgery and first stool passage | up to 1-6 Days after surgery | 
| Time to first ambulation | The time between end of surgery and first time ambulation from bed | up to 1-6 Days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative ileus, prospective study, case-control, open surgery, laparoscopic surgery, bowel recovery, intestinal recovery, gut recovery