Clinical trial NCT01011023: Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study
Official title: Unnecessary Gastric Decompression in Distal Elective Bowel Anastomoses in Children. A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unnecessary Nasogastric Tube
Bowel Anastomosis
Keywords: Bowel anastomosis
nasogastric tube
children
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective. To study the role of nasogastric drainage to prevent postoperative complications in children with \<b\>distal\</b\> 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). \<b\>As an equivalence study the investigators expected that the two techniques were equivalent.\</b\> 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. \<b\>Being an equivalence study, the default delta generated by the Stata command "equim" was used to demonstrate the equivalence between both groups.\</b\> 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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
  * 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.

Primary outcomes:
measure: beginning peristalsis, beginning bowel movement, beginning ambulation, time to full diet intake, post-operative stay.
timeFrame: first 5 postoperative days
Secondary outcomes:
measure: 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.
timeFrame: first 30 postoperative days
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Hospital Infantil de Mexico
state: DF
Study officials:
affiliation: Hospital Infantil de Mexico Federico Gomez
name: ROBERTO DAVILA, SURGEON
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL INFATIL DE MEXICO FEDERICO GOMEZ
name: EDUARDO BRACHO-BLANCHET, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: JOSE MANUEL TOVILLA-MERCADO, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: RICARDO REYES-RETANA, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: PABLO LEZAMA-DEL-VALLE, SURGEON
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: JOSE ALEJANDRO HERNANDEZ-PLATA, SURGERY
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: FERNANDO MONTES-TAPIA, SURGERY
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: ALFONSO REYES-LOPEZ, STATISTIC
role: STUDY_CHAIR
affiliation: HOSPITAL INFANTIL DE MEXICO
name: JAIME NIETO-ZERMEÑO, SURGEON
role: STUDY_CHAIR
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