Early Alimentation Following Colorectal Surgery

NCT00290524 | Unknown Phase 3

• 1 other identifier: QCTG-02-V5
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Colorectal Neoplasms; Crohn Disease

Keywords

Oral alimentation following colorectal surgery; anastomosis; laparoscopy; hospitalization stay

Outcome Measures

Primary Outcomes (1)

• Hospitalisation stay measured in days

Secondary Outcomes (3)

• Gastro-intestinal signs and symptoms

• Treatment of gastro-intestinal signs and symptoms

• Post-surgery complications

Interventions

Oral alimentation started 12 hours after colorectal surgery BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (4)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, h1t 2m4, Canada

RECRUITING

St-Luc Hospital

Montreal, Quebec, Canada

NOT YET RECRUITING

St-Sacrement Hospital

Québec, Quebec, Canada

NOT YET RECRUITING

Ste-Marie Hospital

Trois-Rivières, Quebec, Canada

NOT YET RECRUITING

Related Publications (32)

• 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.

  PMID: 15064261 BACKGROUND

• Olesen KL, Birch M, Bardram L, Burcharth F. Value of nasogastric tube after colorectal surgery. Acta Chir Scand. 1984;150(3):251-3.

  PMID: 6464626 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.

  PMID: 1929130 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.

  PMID: 1553612 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.

  PMID: 8214960 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.

  PMID: 8752247 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.

  PMID: 7748028 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.

  PMID: 2658880 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.

  PMID: 4037908 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.

  PMID: 3970606 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.

  PMID: 11091234 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.

  PMID: 8553212 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.

  PMID: 9627171 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.

  PMID: 9660024 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.

  PMID: 8298938 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.

  PMID: 6788969 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.

  PMID: 3095557 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.

  PMID: 11588077 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.

  PMID: 10675246 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.

  PMID: 14585408 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.

  PMID: 9441769 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.

  PMID: 6780704 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.

  PMID: 11052479 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.

  PMID: 11839327 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.

  PMID: 15132464 BACKGROUND

• Hall JC, Heel K, McCauley R. Glutamine. Br J Surg. 1996 Mar;83(3):305-12. doi: 10.1002/bjs.1800830306.

  PMID: 8665180 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.

  PMID: 12818945 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.

  PMID: 10485781 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.

  PMID: 15166580 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.

  PMID: 11939912 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.

  PMID: 15652945 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.

  PMID: 8686743 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Crohn Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Inflammatory Bowel Diseases; Gastroenteritis

Study Officials

• Pierre Dubé, MD

  Maisonneuve-Rosemont Hospital

  STUDY CHAIR

Central Study Contacts

Pierre Dubé, MD

CONTACT

(514) 252-3822; pierredube@videotron.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: January 1, 2006
• Last Updated: April 7, 2006

Record last verified: 2006-04

Locations

CA (4)