Clinical trial NCT03887845: Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function
Official title: A Prospective Case-control Study Comparing the Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Ileus
Keywords: postoperative ileus
prospective study
case-control
open surgery
laparoscopic surgery
bowel recovery
intestinal recovery
gut recovery
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients enrolled in this study would undergo gastric and colorectal resection surgery

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)

Eligibility criteria: 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

Primary outcomes:
measure: Time to first flatus
timeFrame: up to 1-4 Days after surgery
measure: Length of hospital stay
timeFrame: up to 1-10 Days after surgery
Secondary outcomes:
measure: Time to first bowel movement
timeFrame: up to 1-6 Days after surgery
measure: Time to first oral intake
timeFrame: up to 1-6 Days after surgery
measure: Time to first defecation
timeFrame: up to 1-6 Days after surgery
measure: Time to first ambulation
timeFrame: up to 1-6 Days after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
citation: Cho JS, Kim HI, Lee KY, Son T, Bai SJ, Choi H, Yoo YC. Comparison of the effects of patient-controlled epidural and intravenous analgesia on postoperative bowel function after laparoscopic gastrectomy: a prospective randomized study. Surg Endosc. 2017 Nov;31(11):4688-4696. doi: 10.1007/s00464-017-5537-6. Epub 2017 Apr 7.
citation: Gomez-Pinilla PJ, Binda MM, Lissens A, Di Giovangiulio M, van Bree SH, Nemethova A, Stakenborg N, Farro G, Bosmans G, Matteoli G, Deprest J, Boeckxstaens GE. Absence of intestinal inflammation and postoperative ileus in a mouse model of laparoscopic surgery. Neurogastroenterol Motil. 2014 Sep;26(9):1238-47. doi: 10.1111/nmo.12376. Epub 2014 Jun 26.
citation: Yamamoto S, Hinoi T, Niitsu H, Okajima M, Ide Y, Murata K, Akamoto S, Kanazawa A, Nakanishi M, Naitoh T, Kanehira E, Shimamura T, Suzuka I, Fukunaga Y, Yamaguchi T, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Influence of previous abdominal surgery on surgical outcomes between laparoscopic and open surgery in elderly patients with colorectal cancer: subanalysis of a large multicenter study in Japan. J Gastroenterol. 2017 Jun;52(6):695-704. doi: 10.1007/s00535-016-1262-5. Epub 2016 Sep 20.
citation: Nakamura T, Sato T, Naito M, Ogura N, Yamanashi T, Miura H, Tsutsui A, Yamashita K, Watanabe M. Laparoscopic Surgery is Useful for Preventing Recurrence of Small Bowel Obstruction After Surgery for Postoperative Small Bowel Obstruction. Surg Laparosc Endosc Percutan Tech. 2016 Feb;26(1):e1-4. doi: 10.1097/SLE.0000000000000238.