NCT01572155

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:

  1. 1.to optimize the technique of intra-operative electrical vagus nerve stimulation
  2. 2.to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
  3. 3.to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (collect pilot data)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

3.8 years

First QC Date

April 2, 2012

Last Update Submit

December 3, 2015

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (6)

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

    From date of surgery until postoperative day 1.

  • time to first flatus

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

  • time to tolerance of oral food intake

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

  • time to tolerance of oral food intake AND first defecation

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

  • gastrointestinal symptoms (nausea, pain, bloating)

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

  • +1 more secondary outcomes

Study Arms (3)

Sham stimulation

NO INTERVENTION

No stimulation of nervus vagus

Vagus stimulation 1

ACTIVE COMPARATOR

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

Procedure: Vagus stimulation 1

Vagus stimulation 2

ACTIVE COMPARATOR

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

Procedure: Vagus stimulation 2

Interventions

Vagus stimulation 1PROCEDURE

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

Vagus stimulation 1
Vagus stimulation 2PROCEDURE

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

Vagus stimulation 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 10486602BACKGROUND

  • 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.

    PMID: 9833803BACKGROUND

  • 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.

    PMID: 26011782DERIVED

Study Officials

  • Guy Boeckxstaens, M.D.

    Catholic University Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2012

First Posted

April 6, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

BE(1)