Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

NCT03887845 | Completed DMC

• 1 other identifier: 858105185
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to first bowel movement

  up to 1-6 Days after surgery

• Time to first oral intake

  up to 1-6 Days after surgery

• Time to first defecation

  up to 1-6 Days after surgery

• Time to first ambulation

  up to 1-6 Days after surgery

Study Arms (2)

Open gastrointestinal surgery

All patients enrolled in this group would undergo open gastric and colorectal resection surgery.

Procedure: Surgery

Laparoscopic gastrointestinal surgery

All patients enrolled in this group would undergo laparoscopic gastric and colorectal resection surgery.

Procedure: Surgery

Interventions

Surgery PROCEDURE

The respective surgical approach for any gastric and colorectal surgery

Laparoscopic gastrointestinal surgery; Open gastrointestinal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related 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;31(11):4688-4696. doi: 10.1007/s00464-017-5537-6. Epub 2017 Apr 7.

  PMID: 28389801 RESULT

• 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.

  PMID: 24966010 RESULT

• 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.

  PMID: 27650199 RESULT

• 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.

  PMID: 26771166 RESULT

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: August 1, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 31, 2019
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)