NCT02524626

Brief Summary

Hypothesis: Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead to a faster postoperative recovery after abdominal surgery. Aims: In the present study, the investigators want evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. In addition, the investigators want to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To this end, the following aims are formulated:

  1. 1.to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing
  2. 2.to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire)
  3. 3.to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

May 7, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

May 7, 2015

Last Update Submit

February 7, 2023

Conditions

Postoperative Ileus

Keywords

Vagus nerve stimulationPostoperative ileus

Outcome Measures

Primary Outcomes (1)

  • The gastrointestinal transit (geometric mean)

    From postoperative day 3 until postoperative day 7

Secondary Outcomes (8)

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

    From the date of surgery until postoperative day 1

  • Time to first flatus

    From the date of surgery until the date of discharge from the hospital (on average 14 days)

  • Time to tolerance of oral food intake

    From the date of surgery until the date of discharge from the hospital (on average 14 days)

  • Time to tolerance of oral food intake and first defecation

    From the date of surgery until the date of discharge from the hospital (on average 14 days)

  • Time to first defecation

    From the date of surgery until the date of discharge from the hospital (on average 14 days)

  • +3 more secondary outcomes

Study Arms (2)

Sham stimulation

SHAM COMPARATOR

no stimulation of vagus nerve

Procedure: Sham stimulation

Vagus stimulation

ACTIVE COMPARATOR

Stimulation of the vagus nerve at the beginning and the end of the surgery

Procedure: Vagus stimulation

Interventions

Sham stimulationPROCEDURE

Sham stimulation

Sham stimulation
Vagus stimulationPROCEDURE

Vagus stimulation

Vagus stimulation

Eligibility Criteria

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

You may qualify if:

  • patients with ovarium, pancreas or colorectal carcinoma eligible for resection

You may not qualify if:

  • preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery
  • 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 (= 11 mmol/l)
  • surgery due to chronic pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

  • 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

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Guy Boeckxstaens, M.D.

    Catholic University Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

May 7, 2015

First Posted

August 17, 2015

Study Start

July 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations

BE(1)