Postoperative IleusPhase 4NCT01440712
Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
A Phase 4 study testing Gastrografin and physiological serum in people with Postoperative Ileus, run by Hospital Universitari de Bellvitge at 3 sites in Spain.
Trial summary
The purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Gastrografin and physiological serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesSpain
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with postoperative ileus after colorectal surgery, defined as the presence from the third postoperative day, abdominal distension, nausea, vomiting with or without abdominal pain or discomfort by dilation of bowel loops, confirmed radiology of the abdomen, and which are: Age > 18 years Patients undergoing laparotomy or laparoscopy for the following variants of colorectal disease with or without stoma:
- Neoplasia.
- Inflammatory disease.
- Diverticular disease. Patients who have been treated with standard PCA as postoperative analgesia. Signed informed consent. Undergoing elective or scheduled
Who cannot join
- Patient's refusal to sign informed consent
- Pregnancy or lactation
- Hypersensitivity to iodinated contrast agents (it´s the only contraindication to oral Gastrografin) Presence of other problems that justify the etiology of postoperative ileus:
- Anastomotic leakages.
- Mesenteric vascular disease.
- Incarcerated hernias.
- Intra-abdominal abscesses or collections.
- Metabolic or electrolyte disturbances. If during the course of the study one of the reasons previously cited as the etiology of postoperative ileus is present, the patient shall also be excluded. Also excluded patients undergoing emergency surgery.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari de la Vall d´Hebron
Barcelona, Barcelona, 08035
Hospital Universitari de Girona
Girona, Girona, 17007
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery
The purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.
- Conditions
- Postoperative Ileus
- Being tested
- Gastrografin, physiological serum
- Keywords
- Gastrografin, Postoperative ileus, Colo-rectal surgery, Effects on morbidity and mortality of postoperative ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrografinDrug
Administration of 100 ml of gastrografin by the nasogastric tube, only once.
physiological serumDrug
Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.
| Study group | Role | What they receive |
|---|---|---|
| Gastrografin | Experimental | Patients located in this group will be treated with the administration of 100 ml of gastrografin by the nasogastric tube, only once, after the diagnosis of postoperative ileus. Receives: Drug: Gastrografin |
| physiological serum | Placebo comparator | Patients included in this group will be treated with 100 ml of physiological serum 0,9% by the nasogastric tube, only once, after the diagnosis of postoperative ileus. Receives: Drug: physiological serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food
Measured: While the patient is admitted to the hospital. An average of 11 days since the intervention.
Secondary outcomes (4)
Hospital stay after diagnosis of ileus
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged.
Measured: While the patient is admitted to the hospital. An average of 11 days since the intervention.
Percentage of patients requiring total parenteral nutrition.
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Measured: While the patient is admitted to the hospital. An average of 11 days since the intervention
Presence of postoperative pain and analgesic required
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Measured: While the patient is admitted to the hospital. An average of 11 days since the intervention
Percentage of mortality during hospitalization.
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Measured: While the patient is admitted to the hospital. An average of 11 days since the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastiano Biondo, Hospital Universitari de Bellvitge
- Investigators
- Sebastiano Biondo, Dr., Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440712
- Sponsor's protocol ID
- Ileus_gastro
- Other IDs
- 2010-024096-87
- Status last verified
- Jul 2014
- First submitted
- 21 Sep 2011
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen JH, Hsieh CB, Chao PC, Liu HD, Chen CJ, Liu YC, Yu JC. Effect of water-soluble contrast in colorectal surgery: a prospective randomized trial. World J Gastroenterol. 2005 May 14;11(18):2802-5. doi: 10.3748/wjg.v11.i18.2802.
PubMed 15884127Biondo S, Pares D, Mora L, Marti Rague J, Kreisler E, Jaurrieta E. Randomized clinical study of Gastrografin administration in patients with adhesive small bowel obstruction. Br J Surg. 2003 May;90(5):542-6. doi: 10.1002/bjs.4150.
PubMed 12734858Abbas SM, Bissett IP, Parry BR. Meta-analysis of oral water-soluble contrast agent in the management of adhesive small bowel obstruction. Br J Surg. 2007 Apr;94(4):404-11. doi: 10.1002/bjs.5775.
PubMed 17380561Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.
PubMed 17435541Waldhausen JH, Schirmer BD. The effect of ambulation on recovery from postoperative ileus. Ann Surg. 1990 Dec;212(6):671-7. doi: 10.1097/00000658-199012000-00004.
PubMed 2256758Bohm B, Milsom JW, Fazio VW. Postoperative intestinal motility following conventional and laparoscopic intestinal surgery. Arch Surg. 1995 Apr;130(4):415-9. doi: 10.1001/archsurg.1995.01430040077017.
PubMed 7710343Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
PubMed 11091234Biondo S, Miquel J, Espin-Basany E, Sanchez JL, Golda T, Ferrer-Artola AM, Codina-Cazador A, Frago R, Kreisler E. A Double-Blinded Randomized Clinical Study on the Therapeutic Effect of Gastrografin in Prolonged Postoperative Ileus After Elective Colorectal Surgery. World J Surg. 2016 Jan;40(1):206-14. doi: 10.1007/s00268-015-3260-9.
PubMed 26446450
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01440712
- Acronym / sponsor ID
- Ileus_gastro
- Conditions
- Postoperative Ileus
- Keywords
- Gastrografin, Postoperative ileus, Colo-rectal surgery, Effects on morbidity and mortality of postoperative ileus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Sep 2011 (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 trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrografin | Experimental | Drug: GastrografinPatients located in this group will be treated with the administration of 100 ml of gastrografin by the nasogastric tube, only once, after the diagnosis of postoperative ileus. |
| physiological serum | Placebo comparator | Drug: physiological serumPatients included in this group will be treated with 100 ml of physiological serum 0,9% by the nasogastric tube, only once, after the diagnosis of postoperative ileus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with postoperative ileus after colorectal surgery, defined as the presence from the third postoperative day, abdominal distension, nausea, vomiting with or without abdominal pain or discomfort by dilation of bowel loops, confirmed radiology of the abdomen, and which are: Age > 18 years Patients undergoing laparotomy or laparoscopy for the following variants of colorectal disease with or without stoma:
Key exclusion criteria (8 listed)
- Patient's refusal to sign informed consent
- Pregnancy or lactation
- Hypersensitivity to iodinated contrast agents (it´s the only contraindication to oral Gastrografin) Presence of other problems that justify the etiology of postoperative ileus:
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 |
|---|---|---|
| GastrografinAdministration of 100 ml of gastrografin by the nasogastric tube, only once. | Drug | Gastrografin |
| physiological serumAdministration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once. | Drug | physiological serum |
Primary outcome
Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food
Time frame: While the patient is admitted to the hospital. An average of 11 days since the intervention.
4 secondary outcomes
Hospital stay after diagnosis of ileus
Time frame: While the patient is admitted to the hospital. An average of 11 days since the intervention.
Percentage of patients requiring total parenteral nutrition.
Time frame: While the patient is admitted to the hospital. An average of 11 days since the intervention
Presence of postoperative pain and analgesic required
Time frame: While the patient is admitted to the hospital. An average of 11 days since the intervention
Percentage of mortality during hospitalization.
Time frame: While the patient is admitted to the hospital. An average of 11 days since the intervention
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 15 Jul 2014.
- Background: PubMed 15884127Chen JH, Hsieh CB, Chao PC, Liu HD, Chen CJ, Liu YC, Yu JC. Effect of water-soluble contrast in colorectal surgery: a prospective randomized trial. World J Gastroenterol. 2005 May 14;11(18):2802-5. doi: 10.3748/wjg.v11.i18.2802.
- Background: PubMed 12734858Biondo S, Pares D, Mora L, Marti Rague J, Kreisler E, Jaurrieta E. Randomized clinical study of Gastrografin administration in patients with adhesive small bowel obstruction. Br J Surg. 2003 May;90(5):542-6. doi: 10.1002/bjs.4150.
- Background: PubMed 17380561Abbas SM, Bissett IP, Parry BR. Meta-analysis of oral water-soluble contrast agent in the management of adhesive small bowel obstruction. Br J Surg. 2007 Apr;94(4):404-11. doi: 10.1002/bjs.5775.
- Background: PubMed 17435541Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.
- Background: PubMed 2256758Waldhausen JH, Schirmer BD. The effect of ambulation on recovery from postoperative ileus. Ann Surg. 1990 Dec;212(6):671-7. doi: 10.1097/00000658-199012000-00004.
- Background: PubMed 7710343Bohm B, Milsom JW, Fazio VW. Postoperative intestinal motility following conventional and laparoscopic intestinal surgery. Arch Surg. 1995 Apr;130(4):415-9. doi: 10.1001/archsurg.1995.01430040077017.
- Background: PubMed 11091234Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
- Derived from this study: PubMed 26446450Biondo S, Miquel J, Espin-Basany E, Sanchez JL, Golda T, Ferrer-Artola AM, Codina-Cazador A, Frago R, Kreisler E. A Double-Blinded Randomized Clinical Study on the Therapeutic Effect of Gastrografin in Prolonged Postoperative Ileus After Elective Colorectal Surgery. World J Surg. 2016 Jan;40(1):206-14. doi: 10.1007/s00268-015-3260-9.
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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.
Sebastiano Biondo, Dr. principal investigator
Hospital Universitari de Bellvitge
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gastrografin and physiological serum in people with Postoperative Ileus, run by Hospital Universitari de Bellvitge at 3 sites in Spain.
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 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: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food (time frame: While the patient is admitted to the hospital. An average of 11 days since the intervention.). 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 NCT01440712, which also lists 8 linked publications.
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 15 Jul 2014.