Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01440712
Other study ID # Ileus_gastro
Secondary ID 2010-024096-87
Status Completed
Phase Phase 4
First received September 21, 2011
Last updated July 12, 2014
Start date December 2011
Est. completion date December 2013

Study information

Verified date July 2014
Source Hospital Universitari de Bellvitge
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics CommitteeSpain: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Spanish Agency of Medicines
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

1. Neoplasia.

2. Inflammatory disease.

3. 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:

1. Anastomotic leakages.

2. Mesenteric vascular disease.

3. Incarcerated hernias.

4. Intra-abdominal abscesses or collections.

5. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gastrografin
Administration of 100 ml of gastrografin by the nasogastric tube, only once.
physiological serum
Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.

Locations

Country Name City State
Spain Hospital Universitari de la Vall d´Hebron Barcelona
Spain Hospital Universitari de Girona Girona
Spain Hospital Universitari Bellvitge L´Hospitalet de Llobregat Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. Review. — View Citation

Biondo S, Parés D, Mora L, Martí Ragué 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. — View Citation

Böhm B, Milsom JW, Fazio VW. Postoperative intestinal motility following conventional and laparoscopic intestinal surgery. Arch Surg. 1995 Apr;130(4):415-9. — View 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. — View 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. — View Citation

Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. Review. — View Citation

Waldhausen JH, Schirmer BD. The effect of ambulation on recovery from postoperative ileus. Ann Surg. 1990 Dec;212(6):671-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food While the patient is admitted to the hospital. An average of 11 days since the intervention. No
Secondary 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. While the patient is admitted to the hospital. An average of 11 days since the intervention. Yes
Secondary 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 While the patient is admitted to the hospital. An average of 11 days since the intervention Yes
Secondary 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 While the patient is admitted to the hospital. An average of 11 days since the intervention Yes
Secondary Percentage of mortality during hospitalization. Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged While the patient is admitted to the hospital. An average of 11 days since the intervention Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT02232893 - Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy Phase 2
Not yet recruiting NCT05001763 - Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy Phase 2
Active, not recruiting NCT04547868 - Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery N/A
Completed NCT02815956 - Tibial Nerve Stimulation and Postoperative Ileus N/A
Completed NCT02947269 - Prucalopride in Postoperative Ileus Phase 3
Recruiting NCT05512741 - Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
Recruiting NCT04675606 - Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies N/A
Completed NCT02161367 - Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery Phase 4
Completed NCT01956643 - Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation N/A
Completed NCT00464425 - Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery Phase 3
Completed NCT00402961 - Trial of Acupuncture for Reduction of Post-Colectomy Ileus Phase 2
Terminated NCT04100265 - ANTERO-5: Gastric Motility in Postoperative Ileus N/A
Recruiting NCT04090073 - Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery N/A
Recruiting NCT03222557 - Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer N/A
Withdrawn NCT02261454 - RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children N/A
Completed NCT02639728 - The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery. N/A
Completed NCT02004652 - Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery Phase 2
Completed NCT00509327 - Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery Phase 4
Completed NCT03097900 - Does Caffeine Enhance Bowel Recovery After Colorectal Surgery? Phase 2