Postoperative Rectal Pain Relief With Ear Vagus Nerve Stimulation
Official title: "Evolution of Postoperative Anal Pain Following Elective Proctological or Rectal Surgery Under the Effect of Transcutaneous Vagal Auricular Stimulation: a Feasibility Study - VAGANAL - Postoperative Pain and Vagal Stimulation"
Run by University Hospital, Angers · NCT07659314 · Data updated 2026-11-12
This study tests whether stimulating the vagus nerve through an ear-based device can reduce pain after anal or rectal surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital, Angers Government |
| Locations | 1 site (Angers, Maine et Loire) |
| Status | Recruiting |
| Started | October 21, 2026 |
| Main results expected | October 21, 2027 |
| Study ends | March 21, 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07659314 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult patients undergoing transanal anal or rectal surgery, planned as outpatient or standard hospitalization, who consent to participate.
✕Probably not a fit
Patients with contraindications to vagus nerve stimulation or those who do not respond to this modality may not experience pain relief.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study explores the feasibility and potential pain-relieving effect of perioperative vagus nerve stimulation using a transcutaneous ear probe in adults undergoing transanal anal or rectal surgery. Participants are assigned to an experimental group receiving vagal stimulation and a control group without stimulation, in a perioperative setting. The goal is to see if this noninvasive approach can lessen postoperative pain during the typical two-week recovery period. The study is conducted at HU Angers under the University Hospital of Angers, with appropriate eligibility criteria to include adults undergoing outpatient or standard hospitalization procedures. Safety considerations include exclusions for epilepsy, pacemakers, pregnancy, and other device-related contraindications.
Why it matters
Potential benefit: If successful, patients may experience less postoperative pain and a smoother recovery after anorectal surgery.
How similar studies have gone: Vagus nerve stimulation has shown analgesic potential in other contexts, but this exact perioperative, transcutaneous approach for anorectal surgery is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient * Underwent anal or rectal surgery via the transanal route * Managed on an outpatient basis or in conventional hospitalization * Having signed a consent to participate in the study Exclusion Criteria: * Patient operated on as an emergency * Rectal surgery via abdominal approach or requiring an abdominal approach during the procedure * Known epileptic patient * Patient with a pacemaker * Patient refusing to participate in the study * Pregnant, breastfeeding, or laboring woman * Patient not affiliated with a social security scheme * Person deprived of liberty by judicial or administrative decision * Person subject to compulsory psychiatric care - Any contraindication mentioned in the instructions for use of the medical device under investigation Exclusion Criteria: * Unscheduled conversion from the transanal route to the abdominal route during surgery
Where it's running
-
HU Angers
Angers, Maine et Loire, France Recruiting
Study contacts
- Study coordinator: Sarfati Marine, MD
- Email: Marine.SarfatiLebreton@chu-angers.fr
- Phone: +33 2 41 35 36 17
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.