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Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03887845
Enrollment
401
Registered
2019-03-25
Start date
2018-08-01
Completion date
2019-12-31
Last updated
2020-05-27

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

Conditions

Postoperative Ileus

Keywords

postoperative ileus, prospective study, case-control, open surgery, laparoscopic surgery, bowel recovery, intestinal recovery, gut recovery

Brief 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.

Detailed description

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)

Interventions

PROCEDURESurgery

The respective surgical approach for any gastric and colorectal surgery

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to first flatusup to 1-4 Days after surgeryThe time between end of surgery and passage of first flatus
Length of hospital stayup to 1-10 Days after surgeryThe time between end of surgery and written discharge ticket

Secondary

MeasureTime frameDescription
Time to first bowel movementup to 1-6 Days after surgeryThe time between end of surgery and first bowel movement
Time to first oral intakeup to 1-6 Days after surgeryThe time between end of surgery and first oral intake \>25% than usual intake
Time to first defecationup to 1-6 Days after surgeryThe time between end of surgery and first stool passage
Time to first ambulationup to 1-6 Days after surgeryThe time between end of surgery and first time ambulation from bed

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026