Postoperative IleusNCT03887845
Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function
An observational study of Postoperative Ileus, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients enrolled in this study would undergo gastric and colorectal resection surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Postoperative Ileus
- Being tested
- Surgery
- Keywords
- postoperative ileus, prospective study, case-control, open surgery, laparoscopic surgery, bowel recovery, intestinal recovery, gut recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
The respective surgical approach for any gastric and colorectal surgery
| Study group | Role | What they receive |
|---|---|---|
| Open gastrointestinal surgery | All patients enrolled in this group would undergo open gastric and colorectal resection surgery. Receives: Procedure: Surgery | |
| Laparoscopic gastrointestinal surgery | All patients enrolled in this group would undergo laparoscopic gastric and colorectal resection surgery. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first flatus
The time between end of surgery and passage of first flatus
Measured: up to 1-4 Days after surgery
Length of hospital stay
The time between end of surgery and written discharge ticket
Measured: up to 1-10 Days after surgery
Secondary outcomes (4)
Time to first bowel movement
The time between end of surgery and first bowel movement
Measured: 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
Measured: up to 1-6 Days after surgery
Time to first defecation
The time between end of surgery and first stool passage
Measured: up to 1-6 Days after surgery
Time to first ambulation
The time between end of surgery and first time ambulation from bed
Measured: up to 1-6 Days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Aug 2018
- Primary completion15 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Zhou, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887845
- Sponsor's protocol ID
- 858105185
- Status last verified
- May 2020
- First submitted
- 21 Mar 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28389801Gomez-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.
PubMed 24966010Yamamoto 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.
PubMed 27650199Nakamura 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.
PubMed 26771166
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case-control Study Comparing the Effects of Open and Laparoscopic Gastrointestinal Surgery on Gastrointestinal Function
- ClinicalTrials.gov ID
- NCT03887845
- Acronym / sponsor ID
- 858105185
- Conditions
- Postoperative Ileus
- Keywords
- postoperative ileus, prospective study, case-control, open surgery, laparoscopic surgery, bowel recovery, intestinal recovery, gut recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open gastrointestinal surgery | – | Procedure: SurgeryAll patients enrolled in this group would undergo open gastric and colorectal resection surgery. |
| Laparoscopic gastrointestinal surgery | – | Procedure: SurgeryAll patients enrolled in this group would undergo laparoscopic gastric and colorectal resection surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients enrolled in this study would undergo gastric and colorectal resection surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryThe respective surgical approach for any gastric and colorectal surgery | Procedure or surgery | Laparoscopic gastrointestinal surgery, Open gastrointestinal surgery |
Primary outcome
Time to first flatus
Time frame: up to 1-4 Days after surgery
The time between end of surgery and passage of first flatus
Length of hospital stay
Time frame: up to 1-10 Days after surgery
The time between end of surgery and written discharge ticket
4 secondary outcomes
Time to first bowel movement
Time frame: up to 1-6 Days after surgery
Time to first oral intake
Time frame: up to 1-6 Days after surgery
Time to first defecation
Time frame: up to 1-6 Days after surgery
Time to first ambulation
Time frame: up to 1-6 Days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Results publication: PubMed 28389801Cho 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.
- Results publication: PubMed 24966010Gomez-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.
- Results publication: PubMed 27650199Yamamoto 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.
- Results publication: PubMed 26771166Nakamura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Ileus, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first flatus (time frame: up to 1-4 Days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887845, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.