Early Alimentation Following Colorectal Surgery

Crohn Disease Clinical Trial

Official title:

Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00290524
• Other study ID #: QCTG-02-V5
• Status: Recruiting
• Phase: Phase 3
• First received: February 9, 2006
• Last updated: April 6, 2006
• Start date: January 2006

Study information

• Verified date: April 2006
• Source: Maisonneuve-Rosemont Hospital
• Contact: Pierre Dubé, MD
• Phone: (514) 252-3822
• Email: pierredube[@]videotron.qc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Crohn Disease

Intervention

Behavioral:
• Oral alimentation started 12 hours after colorectal surgery

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	St-Luc Hospital	Montreal	Quebec
Canada	St-Sacrement Hospital	Quebec
Canada	Ste-Marie Hospital	Trois-Rivieres	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (32)

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Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramèr 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. Review. — View Citation

Habib AS, Gan TJ. Evidence-based management of postoperative nausea and vomiting: a review. Can J Anaesth. 2004 Apr;51(4):326-41. Review. — View Citation

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Nathan BN, Pain JA. Nasogastric suction after elective abdominal surgery: a randomised study. Ann R Coll Surg Engl. 1991 Sep;73(5):291-4. — View Citation

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

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. — View Citation

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. — View Citation

Savassi-Rocha PR, Conceicão 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. — View Citation

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. — View Citation

Schwenk W, Böhm B, Haase O, Junghans T, Müller 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalisation stay measured in days
Secondary	Gastro-intestinal signs and symptoms
Secondary	Treatment of gastro-intestinal signs and symptoms
Secondary	Post-surgery complications