Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887845
• Other study ID #: 858105185
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: December 31, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Procedure:
• Surgery
The respective surgical approach for any gastric and colorectal surgery

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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 — View 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 surge — View 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 Endo — View 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 abdomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first flatus	The time between end of surgery and passage of first flatus	up to 1-4 Days after surgery
Primary	Length of hospital stay	The time between end of surgery and written discharge ticket	up to 1-10 Days after surgery
Secondary	Time to first bowel movement	The time between end of surgery and first bowel movement	up to 1-6 Days after surgery
Secondary	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
Secondary	Time to first defecation	The time between end of surgery and first stool passage	up to 1-6 Days after surgery
Secondary	Time to first ambulation	The time between end of surgery and first time ambulation from bed	up to 1-6 Days after surgery