AzTrials
AzTrials

Colorectal NeoplasmsPhase 3NCT00290524

Early Alimentation Following Colorectal Surgery

A Phase 3 study testing Oral alimentation started 12 hours after colorectal surgery in people with Colorectal Neoplasms and Crohn Disease, run by Maisonneuve-Rosemont Hospital at 4 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms, Crohn Disease
What is being tested?
Oral alimentation started 12 hours after colorectal surgery
How many people
800 participants
Where
4 sitesCanada
Study dates
Jan 2006to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Pierre Dubé, MD contact

(514) 252-3822

pierredube@videotron.qc.ca

Canada4 sites, 4 recruiting

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, h1t 2m4

    Pierre Dubé, MD, (514) 252-3822, pierredube@videotron.qc.ca

    Pierre Dubé, MD

    Recruiting

  • St-Luc Hospital

    Montreal, Quebec

    Carole Richard, MD

    Not yet recruiting

  • St-Sacrement Hospital

    Québec, Quebec

    Louise Provencher, MD

    Not yet recruiting

  • Ste-Marie Hospital

    Trois-Rivières, Quebec

    Marie-Hélène Girouard, MD

    Not yet recruiting

Other trials in Canada

About this study

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

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.

Read the detailed 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.

Being tested
Oral alimentation started 12 hours after colorectal surgery
Keywords
Oral alimentation following colorectal surgery, anastomosis, laparoscopy, hospitalization stay
Medical subject headings
Colorectal Neoplasms, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral alimentation started 12 hours after colorectal surgeryBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalisation stay measured in days

Secondary outcomes (3)

  1. Gastro-intestinal signs and symptoms

  2. Treatment of gastro-intestinal signs and symptoms

  3. Post-surgery complications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290524
Sponsor's protocol ID
QCTG-02-V5
Status last verified
Apr 2006
First submitted
9 Feb 2006
Last updated
7 Apr 2006
Results posted
No

Publications

  • 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.

    PubMed 15064261

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

    PubMed 6464626

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

    PubMed 1929130

  • 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.

    PubMed 1553612

  • 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.

    PubMed 8214960

  • 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.

    PubMed 8752247

  • 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.

    PubMed 7748028

  • 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.

    PubMed 2658880

  • 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.

    PubMed 4037908

  • 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.

    PubMed 3970606

  • 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.

    PubMed 11091234

  • 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.

    PubMed 8553212

  • 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.

    PubMed 9627171

  • 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.

    PubMed 9660024

  • 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.

    PubMed 8298938

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral alimentation started 12 hours after colorectal surgery in people with Colorectal Neoplasms and Crohn Disease, run by Maisonneuve-Rosemont Hospital at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pierre Dubé, MD ((514) 252-3822, pierredube@videotron.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalisation stay measured in days. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290524, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2006.

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