Methods

• Study design: randomised controlled trial; 2‐arm study

• Study duration: August 2006 until July 2010

Participants

• Setting: single‐centre study

• Location: Assuit University Children's Hospital, Egypt

• Health Status: "clinical features of intussusception"

• Number (treatment group/control group): 75 (40/35)

• Age: 5 to 24 months

• Sex (M/F): 59/16

Exclusion criteria: pathological lead points, late neglected intestinal obstruction, bowel perforation or shock

Interventions

Treatment group

• IM dexamethasone sodium sulphate: 0.5 mg/kg/8 h, immediately before the start of enema reduction and every 8 hours thereafter, for a total of 3 doses, plus nasogastric tube, IV fluids, antibiotics, and ultrasound‐guided saline enema reduction

Control group

• Nasogastric tube, IV fluids, antibiotics, and ultrasound‐guided saline enema reduction alone

Outcomes

• Complete reduction by ultrasound‐guided saline enema

• Incidence of recurrence during first 24 hours in hospital and during first week (early recurrence) and 6 months post reduction (late recurrence)

Notes

Procedure details: The technique of ultrasound‐guided saline enema reduction involved the following: "a reservoir filled with warm, normal saline was placed at a maximum height of 120cm above the table, with its upper end opened connected to a 10‐18‐Fr Foley's catheter." The enema could be repeated twice more, after a 30‐minute rest, if the initial attempt failed (i.e. lack of reduction within 5 minutes)

The ratio of participants requiring non‐surgical reduction to those requiring surgical reduction was 60:15. In other words, 4/5 participants had successful reduction achieved with non‐surgical techniques

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“The cases were randomly classified into two groups…”. No further details supplied

Allocation concealment (selection bias)

Unclear risk

“The cases were randomly classified into two groups…”. No further details supplied

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All 75 cases were reported, including those that failed initial intervention: "Cases who failed ultrasound guided saline enema reduction underwent surgical exploration, with operative details and postoperative complications also reported"

Selective reporting (reporting bias)

Low risk

Study includes all expected outcomes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No placebo treatment used in control group

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified who assessed outcomes

Methods

• Study design: randomised controlled trial; 2‐arm study

• Study duration: not stated

Participants

• Setting: not stated

• Location: not stated

• Health status: referred for reduction of ileocolic intussusception

• Number (treatment group/control group): 30 (15/15)

• Age: 3 years or younger

• Sex (M/F): not stated

• Exclusion criteria: suspicion of attending physician of peritonitis, clinical or radiographic evidence of peritonitis or intestinal perforation, radiographic evidence of small‐bowel obstruction, indication that intussusception had been present for over 48 hours, fever over 40° C, hypovolaemic shock, blood loss anaemia (haemoglobin < 80 g/L), contraindication to administration of glucagon (suspected pheochromocytoma, insulinoma, glucagon sensitivity, or uncontrolled diabetes)

Interventions

Treatment group

• Glucagon: 0.05 mg/kg with barium enema injected IV (over 1 minute) when intussusception was identified at fluoroscopy

Control group

• Placebo: 0.05 mg/kg with barium enema injected IV when intussusception was identified at fluoroscopy

Outcomes

• Reduction of intussusception by barium enema

• Failure of procedure at the end of the time limit, but ultimately successful hydrostatic reduction

• Failure of procedure, but intussusception reduced at surgery

• Failure of procedure, and intussusception un‐reduced at surgery

Notes

Procedure details: The enema consisted of barium sulphate suspension of approximately 20% w/v concentration, with the enema bag 1 metre above the table top. The enema could be repeated twice more if the initial attempt failed (i.e. lack of reduction within 5 minutes)

Other details: Glucagon and placebo were supplied by the Eli Lilly Company

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"The injections were given in randomized, double‐blind fashion"; no further details supplied

Allocation concealment (selection bias)

Unclear risk

"The injections were given in randomized, double‐blind fashion"; no further details supplied

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data (randomisation post exclusion)

Selective reporting (reporting bias)

Low risk

Reporting included all outcomes and explained outcomes that were unexpected: "eight of 15 intussusceptions...were successfully reduced" ‐ "two patients in the study suffered complications of intussusception...before full recovery ensued"

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

"The injections were given in randomized, double‐blind fashion...Glucagon and the placebo were supplied in identical vials"

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified who assessed outcomes

Methods

• Study design: randomised controlled trial; 3‐arm study

• Study duration: July 1994 until December 1999

Participants

• Setting: single‐centre study

• Location: Cairo University Children’s Hospital (Abu El Rich)

• Health status: “All patients whose clinical and radiological data confirmed the diagnosis of intussusception were eligible for the study”

• Number (treatment group/control group): 147 (50/97)

• Mean age, months (SD):

  • Treatment 1: 15 (12)

  • Treatment 2 (barium/saline): 17 (16)/16 (15)

• Sex (M/F): 93/54

Exclusion criteria: more than 48 hours of symptoms, general or abdominal signs of toxicity, peritonism or peritonitis, or unreasonable electrolyte levels

Interventions

Participants were prepared in the same manner. Preparation included a nasogastric tube with drainage of the stomach, intravenous fluid deficit replacement, and intravenous metronidazole and cefotaxime

All air insufflations were performed by the paediatric surgeon, who was experienced in the technique, and all barium and saline reductions were done by the radiologist, who was experienced in those 2 techniques

Treatment 1

• Pneumatic reduction via air enema

Treatment 2

• Hydrostatic reduction, via liquid enema; 50 participants were allocated to barium enema; 47 were allocated to ultrasound‐guided saline enema

Outcomes

• Amount of fluoroscopic time

• Rate of successful reduction

Notes

Procedure details: Diagnosis and treatment were provided by a dedicated “intussusception clinical team,” consisting of a single paediatric surgeon, a single paediatric radiologist, and 3 residents; all data were recorded on a specially designed protocol sheet

The study protocol allowed a maximum of 3 attempts at reduction for each participant. An attempt was defined as pneumatic or hydrostatic pressure for 5 minutes

Barium enemas were prepared by routine methods

During enemas administered with liquid contrast material, the top of the bag of liquid contrast agent could be raised to a maximum of 1.5 m above the table top. For air insufflation, the maximum pressure used was 120 mmHg. After 3 unsuccessful attempts, the examination was considered a failure. No sedation was used

Sonographic criteria for successful reduction were disappearance of intussusception and visualisation of passage of fluid and air bubbles from the caecum well into the terminal ileum. After successful reduction, saline solution was replaced by gastrografin, and a single abdominal radiograph was taken again to document the successful reduction

Other details: All air reductions and barium reductions were performed with a GE DRS Prestilix 1600X x‐ray machine. All saline reductions were done under sonographic guidance with Tochiba SSA 140 ultrasound machine

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"...randomisation was based on a table of random numbers, wherein 15 consecutive random numbers were selected and assigned to cases 1 through 15. This list of 15 cases was used repeatedly throughout the study (10 times) with random sequence every time.” This allocation sequence is predictable

Allocation concealment (selection bias)

High risk

"...randomisation was based on a table of random numbers, wherein 15 consecutive random numbers were selected and assigned to cases 1 through 15. This list of 15 cases was used repeatedly throughout the study (10 times) with random sequence every time.” This allocation sequence is predictable

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data (randomisation post exclusion). “Only 76 patients came to follow up examinations”; however these data were not used in this review

Selective reporting (reporting bias)

Unclear risk

No protocol available

Blinding of participants and personnel (performance bias)
All outcomes

High risk

By definition, the paediatric surgeon or radiologist was aware of the procedure each was conducting

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessment involved a treating surgeon or radiologist capable of interpreting sonographic criteria for successful reduction (disappearance of intussusception and visualisation of the passage of fluid and air bubbles from the caecum well into the terminal ileum)

Methods

• Study design: randomised controlled trial

• Study duration: not stated

Participants

• Setting: single‐centre study

• Location: Chang Gung Memorial Hospital, Keelung, Taiwan

• Health status: "intussusception patients"

• Number (treatment/control): 281 (144/137)

• Mean age:

  • Treatment group: 18.2 months ± 5.1

• • Control group: 20.3 months ± 4.7

• Sex (M/F):

• • Treatment group: 96/48

  • Control group: 99/38

• Exclusion criteria: not stated

Interventions

Treatment group

• Dexamethasone sodium phosphate: 0.5 mg/kg injected IM immediately after patient met inclusion criteria, before air enema reduction by radiologist team

Control group

• Normal saline: 0.5 mg/kg injected IM before air enema reduction by radiologist team

Outcomes

• Initial successful reduction

• 72 hours post reduction recurrence of intussusception (early recurrence)

• 1 week post reduction recurrence of intussusception (early recurrence)

• 6 months post reduction recurrence of intussusception (late recurrence)

Notes

Procedure details: no details on procedure provided

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"We designed a randomised, double‐blind study"

Allocation concealment (selection bias)

Unclear risk

"We designed a randomised, double‐blind study"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Data on participants lost to follow‐up not reported

Selective reporting (reporting bias)

Unclear risk

Method of data collection post discharge not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

"We designed a randomised, double‐blind study”

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

It was not specified who assessed outcomes

Methods

• Study design: randomised controlled trial; 2‐arm study

• Study duration: July 1989 until December 1991

Participants

• Setting: single‐centre study

• Location: Children's Hospital, Boston

• Heath status: patient's physicians requested examination to rule out intussusception; 52 of 101 children undergoing investigation had intussusception

• Number (treatment 1/treatment 2): 101 (50/51)

• Mean age:

• • Treatment group 1: 17 months ± 16

  • Treatment group 2: 15 months ± 12

• Sex (M/F):

• • Treatment group 1: 30/20

  • Treatment group 2: 34/17

• Exclusion criteria: patient required a specific contrast, refused consent, required a stronger contrast agent to show mucosa, had increased bowel gas, had indications for water‐soluble contrast agent (risk of perforation), had recent unsuccessful examination of intussusception, or had a language barrier

Interventions

• Both study groups were prepared in the same manner. Sedation was usually achieved with IV pentobarbital sodium (Abbott Labaratories, North Chicago, Illinois), but occasionally with IM meperidine HCL (Sanofi Winthrop, New York, New York) given alone or in combination with IV pentobarbital sodium. A Foley catheter was inserted, and a balloon was inflated in the rectum

Treatment group 1

• Hydrostatic reduction via liquid enema (barium or water‐soluble contrast media) at the radiologist's discretion

Treatment group 2

• Pneumatic reduction via air enema

Outcomes

• Confirmation of intussusception

• Rate of successful intussusception reduction

• Recurrence of intussusception

• Fluoroscopy time

Notes

Procedure details: During the first 1.5 years of the study, barium was the only liquid contrast agent used. During the final year, owing to evolving concepts in intussusception management and changes in personnel, the type of liquid contrast material (water‐soluble or barium) used was determined at the radiologist's discretion

The study protocol allowed a maximum of 3 attempts at reduction for each participant. An attempt was defined as pneumatic or hydrostatic pressure applied for a total of 5 minutes. After 3 unsuccessful attempts, the examination was considered a failure

The concentration of barium used in individual cases was not recorded

Cysto‐Conray II (Iothalamate meglumine 17.2%; Mallinckrodt Medical, St Louis, Missouri) was the water‐soluble enema administered

The air insufflation device included an electronic pop‐off valve that could be set to pressure of 60, 80, or 120 mmHg

Other details: This study examined the accuracy of diagnosis with air versus liquid enema, and thus included participants who did not have intussusception. It was necessary to extrapolate the data of those who did have confirmed intussusception for our review

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

”Randomization was based on a table of random numbers, wherein 20 consecutive random numbers were selected and assigned to cases 1 through 20. Cases assigned even random numbers were to undergo examination with liquid contrast material and those assigned odd random numbers were to be examined with air.” This allocation sequence is predictable and is compromised by the need to extrapolate data for participants with confirmed intussusception

Allocation concealment (selection bias)

High risk

Central randomisation table (n = 20)

Used repeatedly throughout the study. Repetative use of the random number table may have allowed prediction of intervention for participants

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data (randomisation post exclusion). Successful diagnosis of intussusception not significantly different between air and liquid contrast groups

Selective reporting (reporting bias)

Unclear risk

No protocol available. Not all expected outcomes were reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

By definition, the radiologist was aware of the procedure he was conducting

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Radiologist who conducted the procedure recorded results

Methods

• Study design: quasi‐randomised controlled trial (allocation via date of birth); 2‐arm study

• Study duration: not stated

Participants

• Setting: not stated

• Location: St Goran's Children's Hospital, Stockholm, Sweden

• Health status: intussusception radiologically confirmed by barium enema

• Number (treatment/control): 188 (69/119)

• Age (median): 1 month to 5 ½ years (9 months)

• Sex (M/F): not stated

• Exclusion criteria: intestinal obstruction and clinical suspicion of bowel gangrene, clinical and radiological manifestations of peritonitis, high fever with gross bowel obstruction

Interventions

• Following diagnosis by barium enema, groups were allocated to 2 groups

Treatment group

• Glucagon: 0.05 mg/kg injected IM, 5 minutes before barium enema reduction

Control group

• Barium enema reduction, 5 minutes after diagnosis by barium enema, similar to treatment group

Outcomes

• Rate of successful intussusception reduction

• Number of attempts until successful enema reduction of intussusception

• Time until successful reduction of intussusception with enema

Notes

Procedure details: The pressure of the enema employed was kept as uniform as possible, corresponding to 100 to 120 cm of barium suspension

Reduction was considered a failure when an intussusception could no longer be moved in an oral direction after several minutes of effective pressure

5 minutes after a first attempt had failed, a second and later a third attempt was made. Failure after this point meant that the participant was prepared for operation. Participants in the control group with 3 failed attempts were administered IV glucagon, as in the treatment group, and an attempt at hydrostatic reduction was repeated. After a fourth attempt, these participants were prepared for operation

Other details: Study was undertaken in 3 steps (Step 1: initial 3 attempts at reduction as per treatment group; Step 2: participants belonging to the control group were administered glucagon and a fourth attempt was made at reduction; participants with reduction regarded as a failure were prepared for surgery; Step 3: all other participants otherwise not reduced were given a final attempt at reduction before they were prepared for surgery). We have included data only for Step 1, as this step pertains to our outcomes and criteria for inclusion

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Allocation of material to a test group and a reference group according to date of birth; participants born on an even calendar date were given an intramuscular injection of 0.05 mg glucagon/kg body weight

Allocation concealment (selection bias)

Unclear risk

Unclear who allocated participants, and who administered treatment

Incomplete outcome data (attrition bias)
All outcomes

High risk

Not stated why some participants from reference group or control group progressed to steps 2 and 3, and why others were excluded

Selective reporting (reporting bias)

Unclear risk

No protocol available. Not all expected outcomes were reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No placebo given

Treatment group given intramuscular injection; control group given no injection

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

It was not specified who assessed outcomes