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OpenTrials
Completed

NCT Number: NCT03887845

Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

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.

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Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

The respective surgical approach for any gastric and colorectal surgery

Primary outcomes

  1. Time to first flatus

    Time frame: up to 1-4 Days after surgery

    The time between end of surgery and passage of first flatus

  2. Length of hospital stay

    Time frame: up to 1-10 Days after surgery

    The time between end of surgery and written discharge ticket

Secondary outcomes

  1. Time to first bowel movement

    Time frame: up to 1-6 Days after surgery

    The time between end of surgery and first bowel movement

  2. Time to first oral intake

    Time frame: up to 1-6 Days after surgery

    The time between end of surgery and first oral intake >25% than usual intake

  3. Time to first defecation

    Time frame: up to 1-6 Days after surgery

    The time between end of surgery and first stool passage

  4. Time to first ambulation

    Time frame: up to 1-6 Days after surgery

    The time between end of surgery and first time ambulation from bed

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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