Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function

NCT ID: NCT03887845

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

401 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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)

Conditions

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Postoperative Ileus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Open gastrointestinal surgery

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

Surgery

Intervention Type PROCEDURE

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.

Surgery

Intervention Type PROCEDURE

The respective surgical approach for any gastric and colorectal surgery

Interventions

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Surgery

The respective surgical approach for any gastric and colorectal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong Zhou

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 28389801 (View on PubMed)

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.

Reference Type RESULT
PMID: 24966010 (View on PubMed)

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.

Reference Type RESULT
PMID: 27650199 (View on PubMed)

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.

Reference Type RESULT
PMID: 26771166 (View on PubMed)

Other Identifiers

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858105185

Identifier Type: -

Identifier Source: org_study_id

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