Back to resultsAnti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
Primary Purpose
Postoperative Ileus
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Sham stimulation
Vagus stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Ileus focused on measuring Vagus nerve stimulation, Postoperative ileus
Eligibility Criteria
Inclusion Criteria:
- patients with ovarium, pancreas or colorectal carcinoma eligible for resection
Exclusion Criteria:
- 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
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham stimulation
Vagus stimulation
Arm Description
no stimulation of vagus nerve
Stimulation of the vagus nerve at the beginning and the end of the surgery
Outcomes
Primary Outcome Measures
The gastrointestinal transit (geometric mean)
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
Time to first defecation
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time to discharge from the hospital
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
Full Information
NCT ID
NCT02524626
First Posted
May 7, 2015
Last Updated
February 7, 2023
Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02524626
Brief Title
Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
Official Title
Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve: A Potential New Therapeutical Intervention for Shortening Postoperative Ileus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing
to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire)
to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Vagus nerve stimulation, Postoperative ileus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
no stimulation of vagus nerve
Arm Title
Vagus stimulation
Arm Type
Active Comparator
Arm Description
Stimulation of the vagus nerve at the beginning and the end of the surgery
Intervention Type
Procedure
Intervention Name(s)
Sham stimulation
Intervention Description
Sham stimulation
Intervention Type
Procedure
Intervention Name(s)
Vagus stimulation
Intervention Description
Vagus stimulation
Primary Outcome Measure Information:
Title
The gastrointestinal transit (geometric mean)
Time Frame
From postoperative day 3 until postoperative day 7
Secondary Outcome Measure Information:
Title
Gastric stasis (volume of gastric fluid produced by gastric tube on postoperative day 1
Time Frame
From the date of surgery until postoperative day 1
Title
Time to first flatus
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to tolerance of oral food intake
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to tolerance of oral food intake and first defecation
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to first defecation
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Gastrointestinal symptoms (nausea, pain, vomiting, bloating)
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Time to discharge from the hospital
Time Frame
From the date of surgery until the date of discharge from the hospital (on average 14 days)
Title
Levels of pro-inflammatory cytokines in intestinal tissue, serum, peritoneal lavage and supernatant of stimulated whole blood
Time Frame
From the date of surgery until the date of lab analysis (up to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with ovarium, pancreas or colorectal carcinoma eligible for resection
Exclusion Criteria:
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
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
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
Learn more about this trial
Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve
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