Back to resultsStudy of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
Primary Purpose
Postoperative Ileus
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Gastrografin
physiological serum
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Ileus focused on measuring Gastrografin, Postoperative ileus, Colo-rectal surgery, Effects on morbidity and mortality of postoperative ileus
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital Universitari Bellvitge
- Hospital Universitari de la Vall d´Hebron
- Hospital Universitari de Girona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gastrografin
physiological serum
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food
Secondary Outcome Measures
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.
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
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
Percentage of mortality during hospitalization.
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Full Information
NCT ID
NCT01440712
First Posted
September 21, 2011
Last Updated
July 12, 2014
Sponsor
Hospital Universitari de Bellvitge
1. Study Identification
Unique Protocol Identification Number
NCT01440712
Brief Title
Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
Official Title
Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
Gastrografin, Postoperative ileus, Colo-rectal surgery, Effects on morbidity and mortality of postoperative ileus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastrografin
Arm Type
Experimental
Arm Description
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.
Arm Title
physiological serum
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gastrografin
Intervention Description
Administration of 100 ml of gastrografin by the nasogastric tube, only once.
Intervention Type
Drug
Intervention Name(s)
physiological serum
Intervention Description
Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Hospital stay after diagnosis of ileus
Description
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged.
Time Frame
While the patient is admitted to the hospital. An average of 11 days since the intervention.
Title
Percentage of patients requiring total parenteral nutrition.
Description
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Time Frame
While the patient is admitted to the hospital. An average of 11 days since the intervention
Title
Presence of postoperative pain and analgesic required
Description
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Time Frame
While the patient is admitted to the hospital. An average of 11 days since the intervention
Title
Percentage of mortality during hospitalization.
Description
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Time Frame
While the patient is admitted to the hospital. An average of 11 days since the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastiano Biondo, Dr.
Organizational Affiliation
Bellvitge University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Bellvitge
City
L´Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari de la Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari de Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
15884127
Citation
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.
Results Reference
background
PubMed Identifier
12734858
Citation
Biondo 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.
Results Reference
background
PubMed Identifier
17380561
Citation
Abbas 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.
Results Reference
background
PubMed Identifier
17435541
Citation
Delaney 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.
Results Reference
background
PubMed Identifier
2256758
Citation
Waldhausen 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.
Results Reference
background
PubMed Identifier
7710343
Citation
Bohm 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.
Results Reference
background
PubMed Identifier
11091234
Citation
Holte 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.
Results Reference
background
PubMed Identifier
26446450
Citation
Biondo 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.
Results Reference
derived
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Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
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