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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Procedure: Surgery

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)

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients enrolled in this study would undergo gastric and colorectal resection surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open gastrointestinal surgery; All patients enrolled in this group would undergo open gastric and colorectal resection surgery.	Procedure: Surgery; The respective surgical approach for any gastric and colorectal surgery
Laparoscopic gastrointestinal surgery; All patients enrolled in this group would undergo laparoscopic gastric and colorectal resection surgery.	Procedure: Surgery; The respective surgical approach for any gastric and colorectal surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West China Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 23, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: laparoscopic surgery; postoperative ileus; prospective study; open surgery; case-control; bowel recovery; intestinal recovery; gut recovery
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: 858105185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No