Postoperative IleusPhase 2/3PESTINCT05334485
Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery
A Phase 2/3 study testing Pyridostigmine Bromide in people with Postoperative Ileus, run by Stefan Holubar MD MS FACS, FASCRS at 1 site in United States.
Trial summary
A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Pyridostigmine Bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to Oct 2026
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (age 18 and over) patients with benign or malignant colonic or rectal disease who have undergone elective laparoscopic, robotic, or open colorectal resections with or without ostomy construction at our center, and subsequently developed POI, defined as symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool for at least 48 hours postoperatively and require return to NPO status after initial diet attempts with or without placement of an NGT.
- Radiographic confirmation of POI diagnosis either via abdominal radiography (KUB), computed tomography abdomen/pelvis (CT A/P), or both
- ECOG Performance status < 4
- Laboratory evidence of normal organ function, defined as:
- Hemoglobin ≥ 7.0 g/dL
- WBC ≤ 20,000/mcL and ≥ 4,000/mcL
Show all 11Show fewer
- Platelet count ≥ 100,000/mcL or ≤ 100,000,000/mcL
- AST (SGOT) ≤ 2.5 times the institutional upper limit of normal
- ALT (SGPT) ≤ 2.5 times the institutional upper limit of normal
- Total bilirubin within the upper limit of institutional normal range
- Serum Creatinine within the upper limit of institutional normal range
Who cannot join
- Radiographic evidence of bowel obstruction
- Documented intraabdominal septic complications (IASC, such as abdominopelvic abscess, peritonitis, anastomotic leak) at any time prior to or after enrollment
- Isolated small bowel or ostomy surgery without colon or rectal resection
- ASA score 5
- Pregnant or breastfeeding females as PYR is classified by the FDA as a pregnancy risk category C medication with the potential for teratogenic or abortifacient effects and demonstrated secretion into breastmilk with an unknown but potential risk for adverse effects in the nursing infants
- Current use of any other investigational agents including: neostigmine or other acetylcholine esterase inhibitors, alvimopan, metoclopramide, erythromycin, methylnaltrexone, naloxegol, cisapride, and laxatives or cathartics (i.e. milk of magnesia, polyethylene glycol)
- History of allergic reactions attributed to PYR or other acetylcholine esterase inhibitors
- Patients with any of the following uncontrolled, concurrent illnesses: active or latent MG, bronco-constrictive disease (asthma/reactive airway disease), chronic obstructive lung disease (COPD), symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia including bradycardia, renal failure, hepatic failure, gastroparesis, short bowel syndrome (small bowel < 200cm), preexisting short or large bowel dysmotility or pseudo-obstruction, chronic constipation/laxative use, peritoneal carcinomatosis, and psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Stefan D Holubar, MD/MS, 2164447000, holubas@ccf.org
About this study
Official title: Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery (PESTI Trial)
A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.
- Conditions
- Postoperative Ileus
- Being tested
- Pyridostigmine Bromide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridostigmine BromideDrug
Oral 60mg pyridostigmine bromide
PlaceboOther
Oral starch placebo
| Study group | Role | What they receive |
|---|---|---|
| Pyridostigmine | Experimental | Patients randomized to this group will be given 60mg of pyridostigmine bromide orally, every 12 hours. Pyridostigmine will be administered from the time of diagnosis of postoperative ileus until the return of bowel function, or for a maximum of 48 hours. Receives: Drug: Pyridostigmine Bromide |
| Placebo | Placebo comparator | Patients randomized to this group will be given starch orally, every 12 hours for a maximum of 48 hours. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until return of bowel function
Following the administration of either pyridostigmine bromide or placebo, the time (in minutes) until return of bowel function will be recorded. Return of bowel function is defined as the first passage of flatus.
Measured: Time from administration of pyridostigmine bromide or placebo until first passage of flatus for up to 30 days
Incidence of pyridostigmine bromide associated side effects
Side effects of pyridostigmine bromide will be assessed using the Pyridostigmine Bromide Side Effects Scale (PBSES) survey tool. Participants will complete this survey at specific time points to evaluate and monitor for the development of established side effects associated with pyridostigmine bromide administration.
Measured: Participants will complete the survey at enrollment and then again at 30 minutes following each administration of either pyridostigmine bromide or placebo.
Secondary outcomes (5)
Time to passage of stool after postoperative ileus diagnosis
The amount of time (in minutes) from the participant being diagnosed with postoperative ileus confirmed with imaging findings until the first passage of stool.
Measured: Time from the point of postoperative ileus diagnosis until the first passage of stool for up to 30 days
Time to tolerance of solid food after postoperative ileus
The amount of time (in minutes) from the participant being diagnosed with postoperative ileus confirmed with imaging findings until the first tolerance of solid food.
Measured: Time from the point of postoperative ileus diagnosis until first meal in which solid food is tolerated for up to 30 days
Number of participants with complications
The number of participants with any type of complication or adverse event occurring within the first 30-days following surgery.
Measured: 30-day period following surgery
Number of participants requiring re-operation
The number of participants who require a re-operation for any reason during the first 30-days following the initial operation.
Measured: 30-day period following initial surgery
Number of participants requiring re-admission
The number of participants requiring re-admission to the hospital for any reason during the first 30-days following surgery.
Measured: 30-day period following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start3 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Holubar MD MS FACS, FASCRS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Holubar MD MS FACS, FASCRS, The Cleveland Clinic
- Investigators
- Stefan D Holubar, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334485
- Sponsor's protocol ID
- 21-915
- Acronym
- PESTI
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery (PESTI Trial)
- ClinicalTrials.gov ID
- NCT05334485
- Acronym / sponsor ID
- PESTI / 21-915
- Conditions
- Postoperative Ileus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stefan Holubar MD MS FACS, FASCRSUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Apr 2022 (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.
A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridostigmine | Experimental | Drug: Pyridostigmine BromidePatients randomized to this group will be given 60mg of pyridostigmine bromide orally, every 12 hours. Pyridostigmine will be administered from the time of diagnosis of postoperative ileus until the return of bowel function, or for a maximum of 48 hours. |
| Placebo | Placebo comparator | Other: PlaceboPatients randomized to this group will be given starch orally, every 12 hours for a maximum of 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult (age 18 and over) patients with benign or malignant colonic or rectal disease who have undergone elective laparoscopic, robotic, or open colorectal resections with or without ostomy construction at our center, and subsequently developed POI, defined as symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool for at least 48 hours postoperatively and require return to NPO status after initial diet attempts with or without placement of an NGT.
- Radiographic confirmation of POI diagnosis either via abdominal radiography (KUB), computed tomography abdomen/pelvis (CT A/P), or both
- ECOG Performance status < 4
- Laboratory evidence of normal organ function, defined as:
Key exclusion criteria (8 listed)
- Radiographic evidence of bowel obstruction
- Documented intraabdominal septic complications (IASC, such as abdominopelvic abscess, peritonitis, anastomotic leak) at any time prior to or after enrollment
- Isolated small bowel or ostomy surgery without colon or rectal resection
- ASA score 5
- Pregnant or breastfeeding females as PYR is classified by the FDA as a pregnancy risk category C medication with the potential for teratogenic or abortifacient effects and demonstrated secretion into breastmilk with an unknown but potential risk for adverse effects in the nursing infants
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 |
|---|---|---|
| Pyridostigmine BromideOral 60mg pyridostigmine bromide | Drug | Pyridostigmine |
| PlaceboOral starch placebo | Other | Placebo |
Primary outcome
Time until return of bowel function
Time frame: Time from administration of pyridostigmine bromide or placebo until first passage of flatus for up to 30 days
Following the administration of either pyridostigmine bromide or placebo, the time (in minutes) until return of bowel function will be recorded. Return of bowel function is defined as the first passage of flatus.
Incidence of pyridostigmine bromide associated side effects
Time frame: Participants will complete the survey at enrollment and then again at 30 minutes following each administration of either pyridostigmine bromide or placebo.
Side effects of pyridostigmine bromide will be assessed using the Pyridostigmine Bromide Side Effects Scale (PBSES) survey tool. Participants will complete this survey at specific time points to evaluate and monitor for the development of established side effects associated with pyridostigmine bromide administration.
5 secondary outcomes
Time to passage of stool after postoperative ileus diagnosis
Time frame: Time from the point of postoperative ileus diagnosis until the first passage of stool for up to 30 days
Time to tolerance of solid food after postoperative ileus
Time frame: Time from the point of postoperative ileus diagnosis until first meal in which solid food is tolerated for up to 30 days
Number of participants with complications
Time frame: 30-day period following surgery
Number of participants requiring re-operation
Time frame: 30-day period following initial surgery
Number of participants requiring re-admission
Time frame: 30-day period following surgery
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 7 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Stefan D Holubar principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pyridostigmine Bromide in people with Postoperative Ileus, run by Stefan Holubar MD MS FACS, FASCRS at 1 site in United States.
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 11 inclusion and 8 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 7 Jan 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stefan D Holubar (2164447000, holubas@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until return of bowel function (time frame: Time from administration of pyridostigmine bromide or placebo until first passage of flatus for up to 30 days). 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 7 Jan 2026.