Unnecessary Nasogastric TubeNCT01011023

Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study

A study testing Non application of nasogastric tube in the experimental group in people with Unnecessary Nasogastric Tube and Bowel Anastomosis, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 month to 18 years
Conditions the study is for: Unnecessary Nasogastric Tube, Bowel Anastomosis
What is being tested?: Non application of nasogastric tube in the experimental group
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteMexico
Study dates: Sep 2000to Nov 2001
Phase: Interventional
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 1 month to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

All patients between the ages of 1 month to 18 years old that required elective laparotomy with an intestinal anastomosis (jejunum, ileum and colon).

Who cannot join

Non elective anastomosis and high risk groups:
newborns
upper gastrointestinal tract anastomoses (esophagus, gastric, duodenal or jejunal)
bilious-digestive or rectal anastomoses
immunosuppressed patients
gastrostomy or any pre anastomotic derivation

Show all 11Show fewer

multiple anastomoses
chronic intestinal obstruction
intraoperative fluids-electrolyte disorders
reductive enteroplasty (tapering)
emergency operations and patients who did not complete the minimum POP follow up of one month.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital Infantil de Mexico
Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

Objective. To study the role of nasogastric drainage to prevent postoperative complications in children with distal elective bowel anastomosis. Summary Background Data. Nasogastric drainage has been used as a routine measure after gastrointestinal surgery in children and adults, to hasten bowel function, prevent post operative complications and shorten hospital stay. However, there is no former study that states in a scientific manner its benefit in children. Methods. The investigators performed a clinical controlled, randomized trial, comprising 60 children that underwent distal elective bowel anastomoses comparing post operative complications between a group with nasogastric tube in place (n=29) and one without it (n=31). As an equivalence study the investigators expected that the two techniques were equivalent. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and chi square test for qualitative variables. Considering statistically significant a p-value less than 0.05. Being an equivalence study, the default delta generated by the Stata command "equim" was used to demonstrate the equivalence between both groups. Results: Demographic data and diagnosis were comparable in both groups (p=NS). No anastomotic leakage or entero-cutaneous fistulae was found in any patient. The investigators demonstrated equivalency since each confidence interval is entirely contained within delta, except for one variable (beginning deambulation), in which equivalency is suggested. There were no significant differences between groups in abdominal distention, infection, or hospital stay variables. Only one patient in the experimental group required placement of the nasogastric tube due to persistent abdominal distension (3.2%). Conclusions. The routine use of nasogastric drainage can be eliminated after distal elective intestinal surgery in children. It's use should be individualized.

Conditions: Unnecessary Nasogastric Tube, Bowel Anastomosis
Being tested: Non application of nasogastric tube in the experimental group
Keywords: Bowel anastomosis, nasogastric tube, children

What participants receive

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

Non application of nasogastric tube in the experimental groupOther
Avoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube

Study groups in NCT01011023
Study group	Role	What they receive
WITHOUT NASOGASTRIC TUBE	Experimental	1. Experimental group (EG): without NGT, by removing the NGT at the end of the surgery, once the stomach had been aspirated, Receives: Other: Non application of nasogastric tube in the experimental group
WITH NASOGASTRIC TUBE	Active comparator	2. Control group (CG): with NGT, with radiographic corroboration of correct placement after the surgery. Both groups were given: 5-day fasting because it was the therapeutic gold standard at our hospital and our country, intravenous solutions and antibiotics for 5 days, ranitidine, and analgesics, without use of any antiemetic drug. Once the fasting period ended, in the CG the NGT was clamped and withdrawn, and in both groups oral fluids and diet were started. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards. Receives: Other: Non application of nasogastric tube in the experimental group

What is being measured

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

beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay.
Measured: first 5 postoperative days

Secondary outcomes (1)

mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence, gastrointestinal bleeding, and chief complaint as well as anastomotic leak or dehiscence, reoperation and death.
Measured: first 30 postoperative days

Timeline

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

Sep 2000Nov 2001

First posted11 Nov 2009 (estimated)
Study startSep 2000
Primary completionApr 2001
Study completionNov 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Unnecessary Nasogastric TubeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01011023
Sponsor's protocol ID: robdape1
Status last verified: Nov 2009
First submitted: 10 Nov 2009
Last updated: 11 Nov 2009
Results posted: No
Data monitoring committee: Yes

Publications

Dinsmore JE, Maxson RT, Johnson DD, Jackson RJ, Wagner CW, Smith SD. Is nasogastric tube decompression necessary after major abdominal surgery in children? J Pediatr Surg. 1997 Jul;32(7):982-4; discussion 984-5. doi: 10.1016/s0022-3468(97)90382-1.
PubMed 9247217
Sandler AD, Evans D, Ein SH. To tube or not to tube: do infants and children need post-laparotomy gastric decompression? Pediatr Surg Int. 1998 Jul;13(5-6):411-3. doi: 10.1007/s003830050351.
PubMed 9639629
Argov S, Goldstein I, Barzilai A. Is routine use of the nasogastric tube justified in upper abdominal surgery? Am J Surg. 1980 Jun;139(6):849-50. doi: 10.1016/0002-9610(80)90395-5.
PubMed 7386740
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
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
Cunningham J, Temple WJ, Langevin JM, Kortbeek J. A prospective randomized trial of routine postoperative nasogastric decompression in patients with bowel anastomosis. Can J Surg. 1992 Dec;35(6):629-32.
PubMed 1458389
Ordorica-Flores RM, Bracho-Blanchet E, Nieto-Zermeno J, Reyes-Retana R, Tovilla-Mercado JM, Leon-Villanueva V, Varela-Fascinetto G. Intestinal anastomosis in children: a comparative study between two different techniques. J Pediatr Surg. 1998 Dec;33(12):1757-9. doi: 10.1016/s0022-3468(98)90279-2.
PubMed 9869045
Nelson R, Tse B, Edwards S. Systematic review of prophylactic nasogastric decompression after abdominal operations. Br J Surg. 2005 Jun;92(6):673-80. doi: 10.1002/bjs.5090.
PubMed 15912492
Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004929. doi: 10.1002/14651858.CD004929.pub3.
PubMed 17636780
Rogers JL, Howard KI, Vessey JT. Using significance tests to evaluate equivalence between two experimental groups. Psychol Bull. 1993 May;113(3):553-65. doi: 10.1037/0033-2909.113.3.553.
PubMed 8316613

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study
ClinicalTrials.gov ID: NCT01011023
Acronym / sponsor ID: robdape1
Conditions: Unnecessary Nasogastric Tube, Bowel Anastomosis
Keywords: Bowel anastomosis, nasogastric tube, children
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
Study start: Sep 2000
Primary completion: Apr 2001 (actual)
Study completion: Nov 2001 (actual)
First posted: 11 Nov 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
WITHOUT NASOGASTRIC TUBE	Experimental	Other: Non application of nasogastric tube in the experimental group1. Experimental group (EG): without NGT, by removing the NGT at the end of the surgery, once the stomach had been aspirated,
WITH NASOGASTRIC TUBE	Active comparator	Other: Non application of nasogastric tube in the experimental group2. Control group (CG): with NGT, with radiographic corroboration of correct placement after the surgery. Both groups were given: 5-day fasting because it was the therapeutic gold standard at our hospital and our country, intravenous solutions and antibiotics for 5 days, ranitidine, and analgesics, without use of any antiemetic drug. Once the fasting period ended, in the CG the NGT was clamped and withdrawn, and in both groups oral fluids and diet were started. Once the regular diet was tolerated, the patients were discharged and followed up at clinic 30 days afterwards.

Who may qualify

Ages: 1 month to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

All patients between the ages of 1 month to 18 years old that required elective laparotomy with an intestinal anastomosis (jejunum, ileum and colon).

Key exclusion criteria (11 listed)

Non elective anastomosis and high risk groups:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non application of nasogastric tube in the experimental groupAvoid the 5 post operative application of nasogastric tube in the experimental group vs the control group with the usual nasogastric tube	Other	WITH NASOGASTRIC TUBE, WITHOUT NASOGASTRIC TUBE

Primary outcome

beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay.
Time frame: first 5 postoperative days

1 secondary outcome

mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence, gastrointestinal bleeding, and chief complaint as well as anastomotic leak or dehiscence, reoperation and death.
Time frame: first 30 postoperative days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
Background: PubMed 9247217Dinsmore JE, Maxson RT, Johnson DD, Jackson RJ, Wagner CW, Smith SD. Is nasogastric tube decompression necessary after major abdominal surgery in children? J Pediatr Surg. 1997 Jul;32(7):982-4; discussion 984-5. doi: 10.1016/s0022-3468(97)90382-1.
Background: PubMed 9639629Sandler AD, Evans D, Ein SH. To tube or not to tube: do infants and children need post-laparotomy gastric decompression? Pediatr Surg Int. 1998 Jul;13(5-6):411-3. doi: 10.1007/s003830050351.
Background: PubMed 7386740Argov S, Goldstein I, Barzilai A. Is routine use of the nasogastric tube justified in upper abdominal surgery? Am J Surg. 1980 Jun;139(6):849-50. doi: 10.1016/0002-9610(80)90395-5.
Background: PubMed 7748028Cheatham 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.
Background: PubMed 2658880Wolff 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.
Background: PubMed 1553612Savassi-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.
Background: PubMed 1458389Cunningham J, Temple WJ, Langevin JM, Kortbeek J. A prospective randomized trial of routine postoperative nasogastric decompression in patients with bowel anastomosis. Can J Surg. 1992 Dec;35(6):629-32.
Background: PubMed 9869045Ordorica-Flores RM, Bracho-Blanchet E, Nieto-Zermeno J, Reyes-Retana R, Tovilla-Mercado JM, Leon-Villanueva V, Varela-Fascinetto G. Intestinal anastomosis in children: a comparative study between two different techniques. J Pediatr Surg. 1998 Dec;33(12):1757-9. doi: 10.1016/s0022-3468(98)90279-2.
Background: PubMed 15912492Nelson R, Tse B, Edwards S. Systematic review of prophylactic nasogastric decompression after abdominal operations. Br J Surg. 2005 Jun;92(6):673-80. doi: 10.1002/bjs.5090.
Background: PubMed 17636780Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004929. doi: 10.1002/14651858.CD004929.pub3.
Background: PubMed 8316613Rogers JL, Howard KI, Vessey JT. Using significance tests to evaluate equivalence between two experimental groups. Psychol Bull. 1993 May;113(3):553-65. doi: 10.1037/0033-2909.113.3.553.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ROBERTO DAVILA, SURGEON principal investigator

Hospital Infantil de Mexico Federico Gomez

EDUARDO BRACHO-BLANCHET, SURGEON study chair

HOSPITAL INFATIL DE MEXICO FEDERICO GOMEZ

JOSE MANUEL TOVILLA-MERCADO, SURGEON study chair

HOSPITAL INFANTIL DE MEXICO

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 11 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: finished, as of the sponsor's last update on 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay. (time frame: first 5 postoperative 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 NCT01011023, which also lists 11 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 11 Nov 2009.