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Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Primary Purpose

Postoperative Ileus

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Vagus stimulation 1

Vagus stimulation 2

About this trial

This is an interventional treatment trial for Postoperative Ileus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with rectal carcinoma eligible for open rectal resection
Age between 18 and 70 years

Exclusion Criteria:

Preoperative therapeutic abdominal radiation
Evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis)
American Society of Anesthesiologists physical-health status classification (ASA-PS) >3
Poorly regulated diabetes (>200 mg/dl (=11mmol/l))

Sites / Locations

University hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Sham stimulation

Vagus stimulation 1

Vagus stimulation 2

Arm Description

No stimulation of nervus vagus

2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA

2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA

Outcomes

Primary Outcome Measures

levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)

Secondary Outcome Measures

gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)

time to first flatus

time to tolerance of oral food intake

time to tolerance of oral food intake AND first defecation

gastrointestinal symptoms (nausea, pain, bloating)

Time to first defecation

Full Information

NCT ID

NCT01572155

First Posted

April 2, 2012

Last Updated

December 3, 2015

Sponsor

KU Leuven

Collaborators

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT01572155

Brief Title

Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Official Title

Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: Potential New Therapeutic Intervention to Shorten Postoperative Ileus

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Hypothesis: Electrical stimulation of the abdominal vagus nerve has an anti-inflammatory effect and represents a new therapeutic approach to shorten postoperative ileus. Aims: In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. To this end, the following aims are formulated: to optimize the technique of intra-operative electrical vagus nerve stimulation to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (collect pilot data)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Ileus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham stimulation

Arm Type

No Intervention

Arm Description

No stimulation of nervus vagus

Arm Title

Vagus stimulation 1

Arm Type

Active Comparator

Arm Description

2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA

Arm Title

Vagus stimulation 2

Arm Type

Active Comparator

Arm Description

2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA

Intervention Type

Procedure

Intervention Name(s)

Vagus stimulation 1

Intervention Description

2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA

Intervention Type

Procedure

Intervention Name(s)

Vagus stimulation 2

Intervention Description

2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA

Primary Outcome Measure Information:

Title

levels of pro-inflammatory cytokines in serum, peritoneal lavage and supernatant of stimulated PBMCs (peripheral blood mononuclear cell)

Time Frame

From date of surgery until the date of lab analysis (in short time period after taking the blood sample) .Blood samples will be taken before surgery, 2, 24 and 48 hrs after surgery.

Secondary Outcome Measure Information:

Title

gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1)

Time Frame

From date of surgery until postoperative day 1.

Title

time to first flatus

Time Frame

From date of surgery until the date of discharge from the hospital.

Title

time to tolerance of oral food intake

Time Frame

From date of surgery until the date of discharge from the hospital

Title

time to tolerance of oral food intake AND first defecation

Time Frame

From date of surgery until the date of discharge from the hospital

Title

gastrointestinal symptoms (nausea, pain, bloating)

Time Frame

From date of surgery until the date of discharge from the hospital

Title

Time to first defecation

Time Frame

From date of surgery until the date of discharge from the hospital.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with rectal carcinoma eligible for open rectal resection Age between 18 and 70 years Exclusion Criteria: Preoperative therapeutic abdominal radiation Evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis) American Society of Anesthesiologists physical-health status classification (ASA-PS) >3 Poorly regulated diabetes (>200 mg/dl (=11mmol/l))

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guy Boeckxstaens, M.D.

Organizational Affiliation

Catholic University Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

University hospitals Leuven

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

10486602

Citation

Kalff JC, Buchholz BM, Eskandari MK, Hierholzer C, Schraut WH, Simmons RL, Bauer AJ. Biphasic response to gut manipulation and temporal correlation of cellular infiltrates and muscle dysfunction in rat. Surgery. 1999 Sep;126(3):498-509.

Results Reference

background

PubMed Identifier

9833803

Citation

Kalff JC, Schraut WH, Simmons RL, Bauer AJ. Surgical manipulation of the gut elicits an intestinal muscularis inflammatory response resulting in postsurgical ileus. Ann Surg. 1998 Nov;228(5):652-63. doi: 10.1097/00000658-199811000-00004.

Results Reference

background

PubMed Identifier

26011782

Citation

Peters EG, De Jonge WJ, Smeets BJ, Luyer MD. The contribution of mast cells to postoperative ileus in experimental and clinical studies. Neurogastroenterol Motil. 2015 Jun;27(6):743-9. doi: 10.1111/nmo.12579.

Results Reference

derived

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Pilot Study: Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

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