Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
800 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study wants to address the question of whether or not oral alimentation should be begun early in patients following colorectal surgery compared to the classical diet which depends on reappearance of functional intestinal transit. Early oral alimentation following colorectal surgery may decrease hospitalisation stay duration.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Following intestinal surgery, the classical protocol indicates the use of a naso-gastric tube and starvation more or less prolonged of the patient dependent of surgeon's view. Decision to feed the patient is based on gas and feces reappearance after surgery. However, prolonged starvation might be uncomfortable for the patient as well as increasing his hospitalization stay. Moreover, delayed feeding effect on anastomosis and wound healing is controversial and naso-gastric tube use is known to be uncomfortable and may generate secondary adverse events.
Some studies in opened surgery observed that early alimentation was beneficial against post-surgery mortality, infection risk and anastomosis dehiscence. In addition, early feeding seemed to decrease patient hospitalisation stay.
In order to conduct this study, patients having a colorectal surgery will be randomly attributed to the nil per os group, which is based on the reappearance of a functional intestinal transit, or to the experimental group, which will begin alimentation 12 hours after colorectal surgery.
Some studies in opened surgery observed that early alimentation was beneficial against post-surgery mortality, infection risk and anastomosis dehiscence. In addition, early feeding seemed to decrease patient hospitalisation stay.
In order to conduct this study, patients having a colorectal surgery will be randomly attributed to the nil per os group, which is based on the reappearance of a functional intestinal transit, or to the experimental group, which will begin alimentation 12 hours after colorectal surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Colorectal Neoplasms
Crohn Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral alimentation started 12 hours after colorectal surgery
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient 18 years old or more
* Class ASA (American Society of AnaesthesioIogy) I, II or III, +/- E
* Patient willing to participate in the study
* Patient who understands and accepts to sign the informed consent form
* Patient who will undergo elective or urgent colic resection using laparoscopy or opened surgery defined in section B
Section B: patient must meet one of the following inclusion criterion:
* segmental or total colorectal resection with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
* ileal resection in continuity with total or a segment of the colon with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
* Closing of a terminal or loop colostomy
* Class ASA (American Society of AnaesthesioIogy) I, II or III, +/- E
* Patient willing to participate in the study
* Patient who understands and accepts to sign the informed consent form
* Patient who will undergo elective or urgent colic resection using laparoscopy or opened surgery defined in section B
Section B: patient must meet one of the following inclusion criterion:
* segmental or total colorectal resection with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
* ileal resection in continuity with total or a segment of the colon with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
* Closing of a terminal or loop colostomy
Exclusion Criteria
* Class ASA IV or V patient
* Documented problem of gastro-intestinal motility
* Pregnancy
* Any acute or recent (\<10 days) septic event
* Chemotherapy during the 4 weeks preceding surgery
* Previous irradiation surrounding the planned anastomosis location
* Small intestine iatrogenic transparietal laceration done during surgery
* Small intestine synchrone resection without continuity with the colon
* Intra-peritoneal chemotherapy administered during or following surgery
* Presence of residual peritoneal carcinosis at the end of surgery
* Colic surgery associated with another major intra-abdominal surgery
* Creation of a colo-anal or ileo-anal anastomosis
* Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery
* Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery
* Documented problem of gastro-intestinal motility
* Pregnancy
* Any acute or recent (\<10 days) septic event
* Chemotherapy during the 4 weeks preceding surgery
* Previous irradiation surrounding the planned anastomosis location
* Small intestine iatrogenic transparietal laceration done during surgery
* Small intestine synchrone resection without continuity with the colon
* Intra-peritoneal chemotherapy administered during or following surgery
* Presence of residual peritoneal carcinosis at the end of surgery
* Colic surgery associated with another major intra-abdominal surgery
* Creation of a colo-anal or ileo-anal anastomosis
* Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery
* Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maisonneuve-Rosemont Hospital
OTHER
Sponsor Role
lead
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre Dubé, MD
Role: STUDY_CHAIR
Maisonneuve-Rosemont Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Site Status
RECRUITING
St-Luc Hospital
Montreal, Quebec, Canada
Site Status
NOT_YET_RECRUITING
St-Sacrement Hospital
Québec, Quebec, Canada
Site Status
NOT_YET_RECRUITING
Ste-Marie Hospital
Trois-Rivières, Quebec, Canada
Site Status
NOT_YET_RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Canada
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. doi: 10.1007/BF03018236.
Reference Type
BACKGROUND
Olesen KL, Birch M, Bardram L, Burcharth F. Value of nasogastric tube after colorectal surgery. Acta Chir Scand. 1984;150(3):251-3.
Reference Type
BACKGROUND
Nathan BN, Pain JA. Nasogastric suction after elective abdominal surgery: a randomised study. Ann R Coll Surg Engl. 1991 Sep;73(5):291-4.
Reference Type
BACKGROUND
Savassi-Rocha PR, Conceicao SA, Ferreira JT, Diniz MT, Campos IC, Fernandes VA, Garavini D, Castro LP. Evaluation of the routine use of the nasogastric tube in digestive operation by a prospective controlled study. Surg Gynecol Obstet. 1992 Apr;174(4):317-20.
Reference Type
BACKGROUND
Petrelli NJ, Stulc JP, Rodriguez-Bigas M, Blumenson L. Nasogastric decompression following elective colorectal surgery: a prospective randomized study. Am Surg. 1993 Oct;59(10):632-5.
Reference Type
BACKGROUND
Pearl ML, Valea FA, Fischer M, Chalas E. A randomized controlled trial of postoperative nasogastric tube decompression in gynecologic oncology patients undergoing intra-abdominal surgery. Obstet Gynecol. 1996 Sep;88(3):399-402. doi: 10.1016/0029-7844(96)00183-4.
Reference Type
BACKGROUND
Cheatham ML, Chapman WC, Key SP, Sawyers JL. A meta-analysis of selective versus routine nasogastric decompression after elective laparotomy. Ann Surg. 1995 May;221(5):469-76; discussion 476-8. doi: 10.1097/00000658-199505000-00004.
Reference Type
BACKGROUND
Wolff BG, Pembeton JH, van Heerden JA, Beart RW Jr, Nivatvongs S, Devine RM, Dozois RR, Ilstrup DM. Elective colon and rectal surgery without nasogastric decompression. A prospective, randomized trial. Ann Surg. 1989 Jun;209(6):670-3; discussion 673-5. doi: 10.1097/00000658-198906000-00003.
Reference Type
BACKGROUND
Cheadle WG, Vitale GC, Mackie CR, Cuschieri A. Prophylactic postoperative nasogastric decompression. A prospective study of its requirement and the influence of cimetidine in 200 patients. Ann Surg. 1985 Sep;202(3):361-6. doi: 10.1097/00000658-198509000-00014.
Reference Type
BACKGROUND
Bauer JJ, Gelernt IM, Salky BA, Kreel I. Is routine postoperative nasogastric decompression really necessary? Ann Surg. 1985 Feb;201(2):233-6. doi: 10.1097/00000658-198502000-00017.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Lacy AM, Garcia-Valdecasas JC, Pique JM, Delgado S, Campo E, Bordas JM, Taura P, Grande L, Fuster J, Pacheco JL, et al. Short-term outcome analysis of a randomized study comparing laparoscopic vs open colectomy for colon cancer. Surg Endosc. 1995 Oct;9(10):1101-5. doi: 10.1007/BF00188996.
Reference Type
BACKGROUND
Schwenk W, Bohm B, Haase O, Junghans T, Muller JM. Laparoscopic versus conventional colorectal resection: a prospective randomised study of postoperative ileus and early postoperative feeding. Langenbecks Arch Surg. 1998 Mar;383(1):49-55. doi: 10.1007/s004230050091.
Reference Type
BACKGROUND
Milsom JW, Bohm B, Hammerhofer KA, Fazio V, Steiger E, Elson P. A prospective, randomized trial comparing laparoscopic versus conventional techniques in colorectal cancer surgery: a preliminary report. J Am Coll Surg. 1998 Jul;187(1):46-54; discussion 54-5. doi: 10.1016/s1072-7515(98)00132-x.
Reference Type
BACKGROUND
Wexner SD, Cohen SM, Johansen OB, Nogueras JJ, Jagelman DG. Laparoscopic colorectal surgery: a prospective assessment and current perspective. Br J Surg. 1993 Dec;80(12):1602-5. doi: 10.1002/bjs.1800801238.
Reference Type
BACKGROUND
Moss G. Maintenance of gastrointestinal function after bowel surgery and immediate enteral full nutrition. II. Clinical experience, with objective demonstration of intestinal absorption and motility. JPEN J Parenter Enteral Nutr. 1981 May-Jun;5(3):215-20. doi: 10.1177/0148607181005003215. No abstract available.
Reference Type
BACKGROUND
Moore EE, Jones TN. Benefits of immediate jejunostomy feeding after major abdominal trauma--a prospective, randomized study. J Trauma. 1986 Oct;26(10):874-81. doi: 10.1097/00005373-198610000-00003.
Reference Type
BACKGROUND
Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta-analysis of controlled trials. BMJ. 2001 Oct 6;323(7316):773-6. doi: 10.1136/bmj.323.7316.773.
Reference Type
BACKGROUND
Behrns KE, Kircher AP, Galanko JA, Brownstein MR, Koruda MJ. Prospective randomized trial of early initiation and hospital discharge on a liquid diet following elective intestinal surgery. J Gastrointest Surg. 2000 Mar-Apr;4(2):217-21. doi: 10.1016/s1091-255x(00)80059-1.
Reference Type
BACKGROUND
DiFronzo LA, Yamin N, Patel K, O'Connell TX. Benefits of early feeding and early hospital discharge in elderly patients undergoing open colon resection. J Am Coll Surg. 2003 Nov;197(5):747-52. doi: 10.1016/S1072-7515(03)00794-4.
Reference Type
BACKGROUND
Schilder JM, Hurteau JA, Look KY, Moore DH, Raff G, Stehman FB, Sutton GP. A prospective controlled trial of early postoperative oral intake following major abdominal gynecologic surgery. Gynecol Oncol. 1997 Dec;67(3):235-40. doi: 10.1006/gyno.1997.4860.
Reference Type
BACKGROUND
Moss G, Greenstein A, Levy S, Bierenbaum A. Maintenance of GI function after bowel surgery and immediate enteral full nutrition. I. Doubling of canine colorectal anastomotic bursting pressure and intestinal wound mature collagen content. JPEN J Parenter Enteral Nutr. 1980 Nov-Dec;4(6):535-8. doi: 10.1177/0148607180004006535.
Reference Type
BACKGROUND
Kiyama T, Onda M, Tokunaga A, Yoshiyuki T, Barbul A. Effect of early postoperative feeding on the healing of colonic anastomoses in the presence of intra-abdominal sepsis in rats. Dis Colon Rectum. 2000 Oct;43(10 Suppl):S54-8. doi: 10.1007/BF02237227.
Reference Type
BACKGROUND
Khalili TM, Navarro RA, Middleton Y, Margulies DR. Early postoperative enteral feeding increases anastomotic strength in a peritonitis model. Am J Surg. 2001 Dec;182(6):621-4. doi: 10.1016/s0002-9610(01)00818-2.
Reference Type
BACKGROUND
Sigalet DL, Mackenzie SL, Hameed SM. Enteral nutrition and mucosal immunity: implications for feeding strategies in surgery and trauma. Can J Surg. 2004 Apr;47(2):109-16.
Reference Type
BACKGROUND
Hall JC, Heel K, McCauley R. Glutamine. Br J Surg. 1996 Mar;83(3):305-12. doi: 10.1002/bjs.1800830306.
Reference Type
BACKGROUND
Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
Reference Type
BACKGROUND
Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
Reference Type
BACKGROUND
American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.
Reference Type
BACKGROUND
Kranke P, Morin AM, Roewer N, Eberhart LH. Dimenhydrinate for prophylaxis of postoperative nausea and vomiting: a meta-analysis of randomized controlled trials. Acta Anaesthesiol Scand. 2002 Mar;46(3):238-44. doi: 10.1034/j.1399-6576.2002.t01-1-460303.x.
Reference Type
BACKGROUND
Wildhaber BE, Yang H, Spencer AU, Drongowski RA, Teitelbaum DH. Lack of enteral nutrition--effects on the intestinal immune system. J Surg Res. 2005 Jan;123(1):8-16. doi: 10.1016/j.jss.2004.06.015.
Reference Type
BACKGROUND
Buck M, Houglum K, Chojkier M. Tumor necrosis factor-alpha inhibits collagen alpha1(I) gene expression and wound healing in a murine model of cachexia. Am J Pathol. 1996 Jul;149(1):195-204.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QCTG-02-V5
Identifier Type: -
Identifier Source: org_study_id