Crohn's DiseaseNCT02777034
Laparoscopy Combined With Enhanced Recovery Pathway
A study testing ER and UR in people with Crohn's Disease, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- ER and UR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2017
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years≤aged≤75 years) were included if they had histologically or radiographic proven CD with disease localized to the terminal ileum with or without ascending colon involvement.
Who cannot join
- Those patients were excluded：previous bowel resection or strictureplasty, preoperative radiological evidence of large phlegmons/abscesses/enteric fistulas (assessed by magnetic resonance imaging or computed tomography), emergency surgery, and anesthesiological contraindications to laparoscopy.
Trial locations and contacts
1 site in 1 country.
Xiang contact
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Jianjian Xiang, doctor, 008615168326849, ybxjj1990@126.com
About this study
Official title: Short-Term Outcomes of Laparoscopy Combined With Enhanced Recovery Pathway After Ileocolon Resection for Crohn's Disease
Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease.
Read the detailed description
Thirty patients with CD of ileocolon will be randomly assigned to two groups.One group is ERP group which include no bowel preparation nor fasting, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization and restrictive fluid management.In the end,we can compare the time to first flatus、time to first flatus 、postoperative length of stay postoperative hospital expense、complication grade readmission within 30 days of discharge between the two groups.
- Conditions
- Crohn's Disease
- Being tested
- ER, UR
- Keywords
- Laparoscopy, Enhanced Recovery, Fast-track
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EROther
Also called Enhanced Recovery
Preoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）.
Intraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains.
Postoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（<2000ml/d）.
UROther
Also called Un-Enhanced Recovery
Preoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation.
Intraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains.
Postoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（>2000ml/d）.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery | Experimental | Preoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）.
Intraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains.
Postoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（<2000ml/d）. Receives: Other: ER |
| Unenhanced Recovery | Other | Preoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation.
Intraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains.
Postoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（>2000ml/d）. Receives: Other: UR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of Flatus and Defecation
Measured: 0-10 days
Secondary outcomes (1)
The time of liquid diet and semiliquid diet
Measured: 0-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhou, Sir Run Run Shaw Hospital
- Investigators
- Wei Zhou, Doctor, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777034
- Sponsor's protocol ID
- SRRSH20160427-001
- Status last verified
- Apr 2016
- First submitted
- 13 May 2016
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Spinelli A, Bazzi P, Sacchi M, Danese S, Fiorino G, Malesci A, Gentilini L, Poggioli G, Montorsi M. Short-term outcomes of laparoscopy combined with enhanced recovery pathway after ileocecal resection for Crohn's disease: a case-matched analysis. J Gastrointest Surg. 2013 Jan;17(1):126-32; discussion p.132. doi: 10.1007/s11605-012-2012-5. Epub 2012 Sep 5.
PubMed 22948838Andersen J, Kehlet H. Fast track open ileo-colic resections for Crohn's disease. Colorectal Dis. 2005 Jul;7(4):394-7. doi: 10.1111/j.1463-1318.2005.00788.x.
PubMed 15932565Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.
PubMed 22241289Zhu Y, Xiang J, Liu W, Cao Q, Zhou W. Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study. Gastroenterol Res Pract. 2018 Nov 11;2018:9648674. doi: 10.1155/2018/9648674. eCollection 2018.
PubMed 30534152
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Outcomes of Laparoscopy Combined With Enhanced Recovery Pathway After Ileocolon Resection for Crohn's Disease
- ClinicalTrials.gov ID
- NCT02777034
- Acronym / sponsor ID
- SRRSH20160427-001
- Conditions
- Crohn's Disease
- Keywords
- Laparoscopy, Enhanced Recovery, Fast-track
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 May 2016 (estimated)
- 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.
Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease.
Detailed description
Thirty patients with CD of ileocolon will be randomly assigned to two groups.One group is ERP group which include no bowel preparation nor fasting, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization and restrictive fluid management.In the end,we can compare the time to first flatus、time to first flatus 、postoperative length of stay postoperative hospital expense、complication grade readmission within 30 days of discharge between the two groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery | Experimental | Other: ERPreoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）. Intraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains. Postoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（<2000ml/d）. |
| Unenhanced Recovery | Other | Other: URPreoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation. Intraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains. Postoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（>2000ml/d）. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 years≤aged≤75 years) were included if they had histologically or radiographic proven CD with disease localized to the terminal ileum with or without ascending colon involvement.
Key exclusion criteria (1 listed)
- Those patients were excluded：previous bowel resection or strictureplasty, preoperative radiological evidence of large phlegmons/abscesses/enteric fistulas (assessed by magnetic resonance imaging or computed tomography), emergency surgery, and anesthesiological contraindications to laparoscopy.
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 |
|---|---|---|
| ERAlso: Enhanced RecoveryPreoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）. Intraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains. Postoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（<2000ml/d）. | Other | Enhanced Recovery |
| URAlso: Un-Enhanced RecoveryPreoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation. Intraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains. Postoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（>2000ml/d）. | Other | Unenhanced Recovery |
Primary outcome
The time of Flatus and Defecation
Time frame: 0-10 days
1 secondary outcome
The time of liquid diet and semiliquid diet
Time frame: 0-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Results publication: PubMed 22948838Spinelli A, Bazzi P, Sacchi M, Danese S, Fiorino G, Malesci A, Gentilini L, Poggioli G, Montorsi M. Short-term outcomes of laparoscopy combined with enhanced recovery pathway after ileocecal resection for Crohn's disease: a case-matched analysis. J Gastrointest Surg. 2013 Jan;17(1):126-32; discussion p.132. doi: 10.1007/s11605-012-2012-5. Epub 2012 Sep 5.
- Results publication: PubMed 15932565Andersen J, Kehlet H. Fast track open ileo-colic resections for Crohn's disease. Colorectal Dis. 2005 Jul;7(4):394-7. doi: 10.1111/j.1463-1318.2005.00788.x.
- Results publication: PubMed 22241289Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.
- Derived from this study: PubMed 30534152Zhu Y, Xiang J, Liu W, Cao Q, Zhou W. Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study. Gastroenterol Res Pract. 2018 Nov 11;2018:9648674. doi: 10.1155/2018/9648674. eCollection 2018.
- Individual participant dataSharing planned: Yes
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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.
Xiang contact
Wei Zhou, Doctor study chair
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ER and UR in people with Crohn's Disease, run by Sir Run Run Shaw 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianjian Xiang, doctor (008613588706479, nuzwlvran@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of Flatus and Defecation (time frame: 0-10 days). 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 NCT02777034, 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 19 May 2016.