Postoperative IleusPhase 2NCT02004652
Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery
A Phase 2 study testing Prucalopride in people with Postoperative Ileus, run by Jinling Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of gastrointestinal function in patient undergoing major gastrointestinal surgery. The investigators hypothesize that patients who take prucalopride after major gastrointestinal surgery will have shorter duration of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients undergoing elective gastric, small bowel, or partial colonic resection via laparotomy or laparoscopy.
- Patients with American Society of Anaesthesiologists grading I-III
- Informed consent available.
Who cannot join
- Patients with stoma creation, extensive adhesiolysis, total or subtotal colectomy , or patients who had a history of total or subtotal colectomy.
- Patients who developed intraoperative problems or complications, or had peritoneal carcinomatosis.
- Patients who developed serious complications within 24 hours after surgery.
- Those who received epidural anesthesia or analgesia.
- Patients who received other prokinetic drugs.
- Patients who were allergic to prucalopride.
Show all 10Show fewer
- Patients with severe comorbidity and/or organ(kidney, liver, and heart) dysfunction
- Patients had complete bowel obstruction
- Patients who have participated other clinical trials.
- Patients who have short bowel(<200cm small bowel) or history of constipation.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
About this study
Official title: A Randomized, Controlled, Double-blind Efficacy and Tolerability Study Of Prucalopride For The Treatment Of Postoperative Ileus In Patients Undergoing Gastrointestinal Surgery
The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of gastrointestinal function in patient undergoing major gastrointestinal surgery. The investigators hypothesize that patients who take prucalopride after major gastrointestinal surgery will have shorter duration of postoperative ileus.
Read the detailed description
Postoperative ileus (POI), an interruption of bowel motility function, virtually occurs in all patients undergoing major gastrointestinal(GI) surgery. This functional impairment persists for a variable duration, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. Therefore, time of return of colonic function is the the major determinant of duration of POI. Attempts to reduce the duration of POI have prompted the implementation of fast track surgery including early removal of the nasogastric tube, early feeding, alvimopan, gum chewing, and prompt ambulation. However, it is still reported to be more than 4-5 days in most of the randomized trial. Therefore, methods specifically aiming at promoting postoperative colon motility may further enhance the GI function recovery, and prucalopride may be one of the options.
Prucalopride, a substituted benzamide with selective 5-HT4 agonist activity, has been shown previously to significant improve colon motility and transit, but it only has mild effect on gastric or small bowel transit. The drug is well tolerated with no significant adverse effects. Recently, prucalopride has been approved in Europe and America for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. However, its usage in the postoperative period has not been tested. This study will test the ability and safety of prucalopride given 24hrs after GI surgery to hasten the recovery of GI function.
- Conditions
- Postoperative Ileus
- Being tested
- Prucalopride, Placebo
- Keywords
- Prucalopride, Gastrointestinal Diseases, Postoperative ileus, Randomised trial
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Resolor
Prucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment
PlaceboDrug
Vitamin, 50mg, tablet.
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride | Experimental | Prucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment Receives: Drug: Prucalopride |
| Placebo | Placebo comparator | Vitamin C, 50mg, tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool
Measured: up to 30 days after surgery
Secondary outcomes (11)
Time of first passing flatus reported by the patients(hours)
Measured: up to 30 days after surgery
Time to resume solid diet or total enteral nutrition(TEN)(days)
Measured: up to 30 days after surgery
Length of postoperative hospital stay (LOS)(days)
Measured: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days
Overall post-operative complication rate defined according to the Clavien-Dindo Classification
Measured: up to 30 days after surgery
Overall cost (RMB)
Measured: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days
Pain scores on visual analogue scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable) on the first 3 postoperative days and postoperative analgesic requirement (number of doses on 50-mg Pethidine)
Measured: up to postoperative day 3
Time to walk independently(days)
Measured: up to 30 days after surgery
Hospital Readmission Rates Post 30-day Discharge
Measured: up to 30 days after discharge
Length of postoperative ICU stay (days)
Measured: up to 30 days after surgery
Incidence of adverse events related to drug usage
Diarrhoea,Flatulence,Nausea,Abdominal pain,Headaches,Menstrual disorder,Dizziness ,Skeletal pain,ECG nodal arrhythmia
Measured: up to 7 days after drug usage
Reinsertion of nasogastric tube
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Jianfeng Gong, MD, Principal investigator, Department of general surgery,Jinling hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004652
- Sponsor's protocol ID
- RIGS-2013-PRU
- Status last verified
- Sep 2016
- First submitted
- 26 Nov 2013
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gong J, Xie Z, Zhang T, Gu L, Yao W, Guo Z, Li Y, Lu N, Zhu W, Li N, Li J. Randomised clinical trial: prucalopride, a colonic pro-motility agent, reduces the duration of post-operative ileus after elective gastrointestinal surgery. Aliment Pharmacol Ther. 2016 Apr;43(7):778-89. doi: 10.1111/apt.13557. Epub 2016 Feb 15.
PubMed 26880227
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Efficacy and Tolerability Study Of Prucalopride For The Treatment Of Postoperative Ileus In Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT02004652
- Acronym / sponsor ID
- RIGS-2013-PRU
- Conditions
- Postoperative Ileus
- Keywords
- Prucalopride, Gastrointestinal Diseases, Postoperative ileus, Randomised trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- 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.
The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of gastrointestinal function in patient undergoing major gastrointestinal surgery. The investigators hypothesize that patients who take prucalopride after major gastrointestinal surgery will have shorter duration of postoperative ileus.
Detailed description
Postoperative ileus (POI), an interruption of bowel motility function, virtually occurs in all patients undergoing major gastrointestinal(GI) surgery. This functional impairment persists for a variable duration, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. Therefore, time of return of colonic function is the the major determinant of duration of POI. Attempts to reduce the duration of POI have prompted the implementation of fast track surgery including early removal of the nasogastric tube, early feeding, alvimopan, gum chewing, and prompt ambulation. However, it is still reported to be more than 4-5 days in most of the randomized trial. Therefore, methods specifically aiming at promoting postoperative colon motility may further enhance the GI function recovery, and prucalopride may be one of the options.
Prucalopride, a substituted benzamide with selective 5-HT4 agonist activity, has been shown previously to significant improve colon motility and transit, but it only has mild effect on gastric or small bowel transit. The drug is well tolerated with no significant adverse effects. Recently, prucalopride has been approved in Europe and America for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. However, its usage in the postoperative period has not been tested. This study will test the ability and safety of prucalopride given 24hrs after GI surgery to hasten the recovery of GI function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prucalopride | Experimental | Drug: PrucalopridePrucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment |
| Placebo | Placebo comparator | Drug: PlaceboVitamin C, 50mg, tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients undergoing elective gastric, small bowel, or partial colonic resection via laparotomy or laparoscopy.
- Patients with American Society of Anaesthesiologists grading I-III
- Informed consent available.
Key exclusion criteria (10 listed)
- Patients with stoma creation, extensive adhesiolysis, total or subtotal colectomy , or patients who had a history of total or subtotal colectomy.
- Patients who developed intraoperative problems or complications, or had peritoneal carcinomatosis.
- Patients who developed serious complications within 24 hours after surgery.
- Those who received epidural anesthesia or analgesia.
- Patients who received other prokinetic drugs.
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 |
|---|---|---|
| PrucaloprideAlso: ResolorPrucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment | Drug | Prucalopride |
| PlaceboVitamin, 50mg, tablet. | Drug | Placebo |
Primary outcome
Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool
Time frame: up to 30 days after surgery
11 secondary outcomes
Time of first passing flatus reported by the patients(hours)
Time frame: up to 30 days after surgery
Time to resume solid diet or total enteral nutrition(TEN)(days)
Time frame: up to 30 days after surgery
Length of postoperative hospital stay (LOS)(days)
Time frame: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days
Overall post-operative complication rate defined according to the Clavien-Dindo Classification
Time frame: up to 30 days after surgery
Overall cost (RMB)
Time frame: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days
Pain scores on visual analogue scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable) on the first 3 postoperative days and postoperative analgesic requirement (number of doses on 50-mg Pethidine)
Time frame: up to postoperative day 3
Time to walk independently(days)
Time frame: up to 30 days after surgery
Hospital Readmission Rates Post 30-day Discharge
Time frame: up to 30 days after discharge
Length of postoperative ICU stay (days)
Time frame: up to 30 days after surgery
Incidence of adverse events related to drug usage
Time frame: up to 7 days after drug usage
Reinsertion of nasogastric tube
Time frame: up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Derived from this study: PubMed 26880227Gong J, Xie Z, Zhang T, Gu L, Yao W, Guo Z, Li Y, Lu N, Zhu W, Li N, Li J. Randomised clinical trial: prucalopride, a colonic pro-motility agent, reduces the duration of post-operative ileus after elective gastrointestinal surgery. Aliment Pharmacol Ther. 2016 Apr;43(7):778-89. doi: 10.1111/apt.13557. Epub 2016 Feb 15.
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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. This study is not recruiting at the moment.
Jianfeng Gong, MD principal investigator
Department of general surgery,Jinling hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prucalopride in people with Postoperative Ileus, run by Jinling Hospital, China at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 30 Sep 2016. 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 China. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004652, which also lists 1 linked publication.
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 30 Sep 2016.