Laparoscopy Combined With Enhanced Recovery Pathway

NCT ID: NCT02777034

Last Updated: 2016-05-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

Brief Summary

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Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease.

Detailed Description

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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

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

ER

Intervention Type OTHER

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).

Unenhanced 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).

Group Type OTHER

UR

Intervention Type 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).

Interventions

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ER

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).

Intervention Type OTHER

UR

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).

Intervention Type OTHER

Other Intervention Names

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Enhanced Recovery Un-Enhanced Recovery

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhou

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Zhou, Doctor

Role: STUDY_CHAIR

Sir Run Run Shaw Hospital

Locations

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Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianjian Xiang, doctor

Role: CONTACT

008613588706479

Xiang

Role: CONTACT

Facility Contacts

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Jianjian Xiang, doctor

Role: primary

008615168326849

References

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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.

Reference Type RESULT
PMID: 22948838 (View on PubMed)

Andersen 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.

Reference Type RESULT
PMID: 15932565 (View on PubMed)

Veenhof 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.

Reference Type RESULT
PMID: 22241289 (View on PubMed)

Zhu 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.

Reference Type DERIVED
PMID: 30534152 (View on PubMed)

Other Identifiers

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SRRSH20160427-001

Identifier Type: -

Identifier Source: org_study_id

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