Rectal SurgeryVAGANALNCT07659314
Post Operative Pain and Vagal Stimulation
A study testing Experimental arm in people with Rectal Surgery and Pain (Visceral, Somatic, or Neuropathic), run by University Hospital, Angers at 1 site in France.
Trial summary
Anorectal surgery is a type of surgery that can cause anal pain, particularly in the context of hemorrhoid surgery or anal fissure surgery. Generally, the period of discomfort related to the pain lasts about two weeks. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic), Vagal Nerve Stimulation
- What is being tested?
- Experimental arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2026to 21 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
- Unscheduled conversion from the transanal route to the abdominal route during surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
HU Angers
Angers, Maine et Loire, 49933
Marine SARFATI-LEBRETON, MD, + 33 2 41 35 36 17, marine.sarfatilebreton@chu-angers.fr
Aurelien VENARA, MD, +33 2 41 35 36 18, auvenara@chu-angers.fr
About this study
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"
Anorectal surgery is a type of surgery that can cause anal pain, particularly in the context of hemorrhoid surgery or anal fissure surgery. Generally, the period of discomfort related to the pain lasts about two weeks. There is a nerve (the vagus nerve) whose stimulation via a probe placed in the ear can reduce stress and chronic pain. Its ease of use makes it a promising tool for treating pain. Vagal auricular stimulation could be an interesting option in the management of postoperative pain of the anus and rectum. Its efficacy or feasibility in this context has never been evaluated.
The aim of this study is to evaluate the feasibility in this context and to assess the extend of pain reduction associated with perioperative nerve vagus stimulation by a medical device (Transcutaneous Electrical Nerve Stimulator (TENS ECO Plus)). It is offered to adult patients undergoing transanal anal or rectal surgery on an outpatient or inpatient basis as part of a scheduled procedure.
Read more
Patients to be included in the study are selected during the initial pre-operative consultation with the surgeon. Once the surgical indication is confirmed and the patient fulfills the study eligibility criteria, the investigator provides them with oral information about the study. The patient is also given an information sheet (written in language understandable to the patient) and a consent form.
During this initial visit, demographic data and information regarding the surgical indication are collected.
Stimulation begins two days before surgery (twice daily), followed by stimulation on the morning of surgery, one hour before arrival in the operating room. Successful completion of the stimulation, as well as any complications, are recorded in the patient diary.
On the day of surgery (day 0), data concerning the procedure and the maximum visual analogue scale (VAS) are collected in the recovery room. Analgesic consumption is also recorded.
On the evening of the procedure, stimulation is performed and adherence is recorded.
Maximum and mean VAS are collected on postoperative day 1 and then daily in the patient diary for 15 days.
Vagus nerve stimulation is performed morning and evening for 15 days. VAS scores, adherence, analgesic consumption, the date of the first bowel movement and its painfulness, as well as any complications related to the stimulation are noted in the patient diary. On day 3 (+/- 2 days) after the procedure, and at the end of the 15-day postoperative period, the patient will be contacted by phone or text message by the investigator team to remind them to complete the notebook.
On day 30 (+/- 5 days), the patient returns for a follow-up visit. The patient diary and equipment are collected. Complications are recorded, as well as quality of life during the postoperative month (SF-36 form).
For patients, the expected benefits are significant, as postoperative quality of life is expected to improve through reduced pain. Furthermore, decreasing the use of step II and III analgesics should shorten the recovery period and promote better overall recovery.
- Being tested
- Experimental arm, Control arm
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armDevice
active vagus nerve stimulation
Control armDevice
no active vagus nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| active nerve vagus stimulator | Experimental | assessment of rectal post operative pain with active nerve vagus stimulation Receives: Device: Experimental arm |
| control arm | Sham comparator | assessment of rectal post operative pain without active nerve vagus stimulation Receives: Device: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain after perioperative auricular vagus nerve stimulation
The intensity of anal pain is measured by the Visual Analog Scale (VAS) from 0 to 10 in the recovery room and then every day for 15 days. This VAS is assessed in patients treated with auricular vagus active nerve stimulation and in patients with a inactive device. The higher score means a worse outcome.
Measured: day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15
consumption of analgesic
the post-operative consumption of analgesic is evaluated in the recovery room (day 0) and then every day for 15 days. Post-operative consumption is assessed in patients treated with auricular vagus active nerve stimulation and in patients with a inactive device.
Measured: From Day 0 to Day 15
Secondary outcomes (4)
Delay in gastrointestinal motility recovery (passage of stool) and post-defecatory pain
The gastrointestinal transit recovery after surgery is recorded in the patients treated with active device and in patients treated with inactive device. Post defecatory pain more than 30 min is also reported in the patients with active and with inactive device.
Measured: from day 0 to day 30
Quality of life of patients after surgery
quality of life by health survey SF 36 (the 36-item Short Form Health Survey) is assessed at the day 30 after surgery in the two groups of patients (active device and no active device). SF 36 covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: Day 30
adverse events
adverse events occuring during the first month after surgery and specifically related to the surgery are collected by the investigator for the two groups of patients
Measured: day 30
acceptability of perioperative auricular vagus nerve stimulation by the patient
The acceptability of treatment by perioperative auricular vagal stimulation is assessed at day 15 by asked question to the two groups of patients. The question is "do you think that the treatment with vagus nerve stimulation is non-binding?"
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start21 Oct 2026
- Primary completion21 Oct 2027 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659314
- Sponsor's protocol ID
- 49RC25-0293
- Other IDs
- 2026-A01004-47
- Acronym
- VAGANAL
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT07659314
- Acronym / sponsor ID
- VAGANAL / 49RC25-0293
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- 21 Oct 2027 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorectal surgery is a type of surgery that can cause anal pain, particularly in the context of hemorrhoid surgery or anal fissure surgery. Generally, the period of discomfort related to the pain lasts about two weeks. There is a nerve (the vagus nerve) whose stimulation via a probe placed in the ear can reduce stress and chronic pain. Its ease of use makes it a promising tool for treating pain. Vagal auricular stimulation could be an interesting option in the management of postoperative pain of the anus and rectum. Its efficacy or feasibility in this context has never been evaluated.
The aim of this study is to evaluate the feasibility in this context and to assess the extend of pain reduction associated with perioperative nerve vagus stimulation by a medical device (Transcutaneous Electrical Nerve Stimulator (TENS ECO Plus)). It is offered to adult patients undergoing transanal anal or rectal surgery on an outpatient or inpatient basis as part of a scheduled procedure.
Patients to be included in the study are selected during the initial pre-operative consultation with the surgeon. Once the surgical indication is confirmed and the patient fulfills the study eligibility criteria, the investigator provides them with oral information about the study. The patient is also given an information sheet (written in language understandable to the patient) and a consent form.
During this initial visit, demographic data and information regarding the surgical indication are collected.
Stimulation begins two days before surgery (twice daily), followed by stimulation on the morning of surgery, one hour before arrival in the operating room. Successful completion of the stimulation, as well as any complications, are recorded in the patient diary.
On the day of surgery (day 0), data concerning the procedure and the maximum visual analogue scale (VAS) are collected in the recovery room. Analgesic consumption is also recorded.
On the evening of the procedure, stimulation is performed and adherence is recorded.
Maximum and mean VAS are collected on postoperative day 1 and then daily in the patient diary for 15 days.
Vagus nerve stimulation is performed morning and evening for 15 days. VAS scores, adherence, analgesic consumption, the date of the first bowel movement and its painfulness, as well as any complications related to the stimulation are noted in the patient diary. On day 3 (+/- 2 days) after the procedure, and at the end of the 15-day postoperative period, the patient will be contacted by phone or text message by the investigator team to remind them to complete the notebook.
On day 30 (+/- 5 days), the patient returns for a follow-up visit. The patient diary and equipment are collected. Complications are recorded, as well as quality of life during the postoperative month (SF-36 form).
For patients, the expected benefits are significant, as postoperative quality of life is expected to improve through reduced pain. Furthermore, decreasing the use of step II and III analgesics should shorten the recovery period and promote better overall recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active nerve vagus stimulator | Experimental | Device: Experimental armassessment of rectal post operative pain with active nerve vagus stimulation |
| control arm | Sham comparator | Device: Control armassessment of rectal post operative pain without active nerve vagus stimulation |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental armactive vagus nerve stimulation | Device | active nerve vagus stimulator |
| Control armno active vagus nerve stimulation | Device | control arm |
Primary outcome
Change of pain after perioperative auricular vagus nerve stimulation
Time frame: day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15
The intensity of anal pain is measured by the Visual Analog Scale (VAS) from 0 to 10 in the recovery room and then every day for 15 days. This VAS is assessed in patients treated with auricular vagus active nerve stimulation and in patients with a inactive device. The higher score means a worse outcome.
consumption of analgesic
Time frame: From Day 0 to Day 15
the post-operative consumption of analgesic is evaluated in the recovery room (day 0) and then every day for 15 days. Post-operative consumption is assessed in patients treated with auricular vagus active nerve stimulation and in patients with a inactive device.
4 secondary outcomes
Delay in gastrointestinal motility recovery (passage of stool) and post-defecatory pain
Time frame: from day 0 to day 30
Quality of life of patients after surgery
Time frame: Day 30
adverse events
Time frame: day 30
acceptability of perioperative auricular vagus nerve stimulation by the patient
Time frame: day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Rectal Surgery
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental arm in people with Rectal Surgery and Pain (Visceral, Somatic, or Neuropathic), run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarfati Marine, MD (+33 2 41 35 36 17, Marine.SarfatiLebreton@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain after perioperative auricular vagus nerve stimulation (time frame: day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.