No new trials were identified in the search updated to July 2003, and as a result no substantive changes were made to the review.
Newborn babies with gastroschisis are born with their gut hanging out of a hole in their belly. If the gut is not put back they could get sick from fluid and heat loss or part of the gut could die or they could get a life-threatening infection. Traditionally the gut is pushed back inside the belly under anaesthetic in the operating theatre but in some hopsitals they push the gut back without anaesthetic in the neonatal ward (i.e., ward reduction). It is not known which method gives better outcomes. The reviewers did not identify any randomised studies comparing the two approaches. They concluded that there is no evidence either supporting or refuting ward reduction of gastroschisis.
Gastroschisis is a congenital anterior abdominal wall defect with the uncovered abdominal contents protruding through the defect. The defect is immediately lateral to, and usually to the right of, a normal umbilicus. Usually small and large bowel protrude through the defect and occasionally other abdominal organs. Reduction of the abdominal contents is required within hours after birth as the infant is at risk not only of water and heat loss from the exposed bowel, but also, of compromised gut circulation with ischaemia and infarction.
A newborn infant with gastroschisis will traditionally have the abdominal contents reduced under general anaesthetic in the operating theatre. Surgical repair of gastroschisis usually requires transporting the infant from the neonatal unit to the operating theatre, endotracheal intubation and general anaesthesia, some exploration of the abdomen and its contents, and mechanical ventilation for a variable amount of time. If reduction of the abdominal contents is not possible at the first procedure an artificial pouch, or silo, can be constructed around the gut and attached to the edge of the defect so that it contains the eviscerated abdominal contents. With the silo in place the gut can be reduced over a longer period of time by decreasing the size of the silo.
Recent case series of infants with gastroschisis are summarised in the Table (see additional Table 01). Three of the case series describe some of the outcomes for the traditional approach (reduction of the abdominal contents under general anaesthetic) - Snyder 1999; Driver 2000; Kitchanan 2000. Mortality is around 10%, often related to septicaemia. Only one of the series reports a duration of ventilation, with a median of 4.5 days (Driver 2000). Delay in establishing full enteral feeding is usual with median durations of around three to four weeks - total parenteral nutrition (TPN) is required for most of this time. The median duration of hospital stay is around 6 weeks. The need for a silo is common - in up to 30% of cases. Survivors may require more than one surgical procedure and compromised segments of bowel may need to be removed. Other possible complications of gastroschisis include haemodynamic compromise of the lower abdomen, kidneys and lower limbs, gastro-intestinal tract perforation, abdominal scars and/or a cosmetically abnormal umbilicus, late surgery for gut adhesions or scar cosmesis, compromised nutrition, and adverse neurological outcome (Burge 1997; Langer 1996; Davies 1997).
To avoid the complications of general anaesthetic and mechanical ventilation it has been proposed that the reduction of abdominal contents can be achieved without endotracheal intubation or anaesthesia - usually in the neonatal unit. For the purposes of this review we have defined 'ward reduction' as "manual reduction of the abdominal organs without general anaesthetic and without surgical incision, at the initial attempt to reduce the abdominal contents".
The first series of patients to undergo ward reduction without anaesthesia was described by Bianchi and Dickson (Bianchi 1998). They questioned the need for general anaesthesia and reported a pilot study in which the infants with gastroschisis were treated with reduction of their gut in the neonatal unit without general anaesthesia, sedation, or analgesia. There were no exclusion criteria, and there was a planned delay of four hours in the reduction as it was felt that the infants were most stable at this time. After the bowel had been returned to the abdominal cavity, the umbilical cord was sutured to the edges of the abdominal wall defect to act as a "plug". The outcomes are summarised in the Table (see additional table 01). After publication of this first case series there was concern voiced by health care professionals regarding Bianchi's technique because of lack of pain control (Huth 1999). Further caution was urged after a report by Dolgin et al (Dolgin 2000) of four patients who had manual reduction of a gastroschisis. Three of the four cases had significant adverse outcomes with multiple surgical procedures and prolonged hospitalisation. The most recent, and largest, case series was reported by Kimble et al (Kimble 2001) - see the Table (see additional table 01). Ward reduction was contemplated in infants who met well-defined selection criteria, which excluded infants that were unstable, or had gut perforation, necrosis or atresia. There was no planned delay and no sutures were used. Analgesia with rectal paracetamol was used. During the study period 35 infants with gastroschisis were encountered: manual reduction was attempted in 29 and was successful in 25. Because of the selection criteria the patients undergoing an initial attempt at ward reduction did well with no mortality, shorter time requiring TPN and decreased duration of hospital stay (when compared with the other case series above - Snyder 1999; Driver 2000; Kitchanan 2000).
Comparisons between case series are not likely to be valid because of case selection bias. Case series describing outcomes following the traditional approach usually report outcomes on all cases of gastroschisis whereas those reporting ward reduction can be selective and outcomes may differ. Outcomes may also differ if the newborn infant is term or preterm, whether analgesia is used or not, and whether the manual reduction procedure is halted after a pre-defined time period or not.
This review updates the existing review of "Ward reduction without general anaesthesia versus reduction and repair under general anaesthesia for gastroschisis in newborn infants" which was last published in the Cochrane Library, Issue 2, 2003 (Davies 2003).
To determine which approach to the immediate surgical treatment of gastroschisis has the better outcomes: ward reduction without general anaesthetic or reduction and repair of the abdominal wall defect under general anaesthesia.
Sub-group analyses were planned to determine whether the results differed by:
Population:
i. gestational age - preterm or term.
Intervention:
i. the planned use of analgesia or local anaesthesia with ward reduction
or not;
ii. use of pre-defined selection criteria (for example excluding infants
that are unstable, have gut perforation, necrosis or atresia, have other
organs requiring reduction besides bowel, or are considered to need a silo
prior to any reduction commencing) prior to attempting manual reduction;
iii. use of a pre-defined time period (30, 60, 90 or 120 minutes) after
which manual reduction is abandoned.
Immediate adverse effects such as altered haemodynamics or cerebral blood flow, and oxygenation.
The standard search strategy for the Cochrane Neonatal Review Group was used. This included searches of electronic databases: Oxford Database of Perinatal Trials; Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2003); MEDLINE (1966 - July 2003); and CINAHL (1982 - July 2003) using MeSH terms 'gastroschisis' and 'infant, newborn'; and previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, journal hand searching. Searches were not restricted to publications in the English language. We did not limit our search to published data.
Criteria and methods used to assess the methodological quality of the trials: standard method of the Cochrane Collaboration and its Neonatal Review Group were used. The three reviewers worked independently to search for and assess trials for inclusion and methodological quality. Studies were to be assessed using the following key criteria: blindness of randomisation, blindness of intervention, completeness of follow up and blinding of outcome measurement. Data were extracted independently by the reviewers. Differences were resolved by discussion and consensus of the reviewers. Where necessary, investigators were to be contacted for additional information or data.
No studies were found meeting the criteria for inclusion in this review.
No studies were found meeting the criteria for inclusion in this review.
No studies were found meeting the criteria for inclusion in this review.
The technique of ward reduction, without general anaesthesia, for the reduction of the abdominal contents in infants with gastroschisis was first described in 1998 (Bianchi 1998). Since 1998 there have been three other case series (Dolgin 2000; Kimble 2001; Bianchi 2002) reporting the outcomes for this technique. The main feature that distinguishes the technique of ward reduction from traditional methods is the absence of a general anaesthetic with the attempt at reduction usually taking place in the neonatal unit without the need for any surgical incision or suturing.
This systematic review has failed to determine which approach to the immediate surgical treatment of gastroschisis has the better outcomes, given the lack of any RCTs comparing the two approaches. It may well be beneficial to avoid general anaesthetic and the need for mechanical ventilation; however, it is not known whether this benefit would be accompanied by any disadvantages. Potentially, outcomes such as mortality, incidence of septicaemia, and duration of total parenteral nutrition and intensive care and hospital stay, and gut loss, may be increased or decreased with ward reduction. Comparisons between case series do not allow us to determine which approach would be better with regard to these aspects of gastroschisis management. Case series describing outcomes following the traditional approach usually report outcomes on all cases of gastroschisis whereas those reporting ward reduction can be selective and, if so, outcomes will usually be better. Kimble et al (Kimble 2001) attempted ward reduction only in infants who met well-defined selection criteria, which excluded infants that were unstable, or had gut perforation, necrosis or atresia. Future RCTs would best be limited to similar infants with uncomplicated gastroschisis.
Bianchi A, Dickson AP. Elective delayed reduction and no anesthesia: 'minimal intervention management' for gastroschisis. J Pediatr Surg 1998;33:1338-1340.
Bianchi A, Dickson AP, Alizai NK. Elective delayed midgut reduction-No anaesthesia for gastroschisis: Selection and conversion criteria. J Pediatr Surg 2002;37:1334-1336.
Burge DM, Ade-Ajayi N. Adverse outcome after prenatal diagnosis of gastroschisis: the role of fetal monitoring. J Pediatr Surg 1997;32:441-444.
Davies BW, Stringer MD. The survivors of gastroschisis. Arch Dis Child 1997;77:158-160.
Dolgin SE, Midulla P, Shlasko E. Unsatisfactory experience with 'minimal intervention management' for gastroschisis. J Pediatr Surg 2000;35:1437-1439.
Driver CP, Bruce J, Bianchi A, Doig CM, Dickson AP, Bowen J. The contemporary outcome of gastroschisis. J Pediatr Surg 2000;35:1719-1723.
Huth MM. Elective delayed reduction and no anaesthesia: "minimal intervention management" for gastroschisis. J Child Family Nursing 1999;2:267-268.
Kimble RM, Singh SJ, Bourke C, Cass DT. Gastroschisis reduction under analgesia in the neonatal unit. J Pediatr Surg 2001;36:1672-1674.
Kitchanan S, Patole SK, Muller R, Whitehall JS. Neonatal outcome of gastroschisis and exomphalos: a 10-year review. J Paediatr Child Health 2000;36:428-430.
Langer JC. Gastroschisis and omphalocele. Semin Pediatr Surg 1996;5:124-128.
Snyder CL. Outcome analysis for gastroschisis. J Pediatr Surg 1999;34:1253-1256.
Davies MW, Kimble RM, Woodgate PG. Ward reduction without general anaesthesia versus reduction and repair under general anaesthesia for gastroschisis in newborn infants (Cochrane Review). In: The Cochrane Library, Issue 3, 2002. Oxford: Update Software.
Davies MW, Kimble RM, Woodgate PG. Ward reduction without general anaesthesia versus reduction and repair under general anaesthesia for gastroschisis in newborn infants (Cochrane Review). In: The Cochrane Library, Issue Issue 2, 2003. Oxford: Update Software.
| Snyder 1999 | Driver 2000 | Kitchanan 2000 | Bianchi 1998 | Kimble 2001 | |
| Years | 1969 - 1999 | 1991 - 1997 | 1988 - 1997 | 1994 - 1997 | 1999 - 2001 |
| Country | USA | England | Australia | England | Australia |
| Method of closure | Reduction under general anaesthesia | Reduction under general anaesthesia | Reduction under general anaesthesia | Ward reduction | Ward reduction |
| Number | 185 | 91 | 21 | 14 | 29 |
| Gestational age, median (range) weeks | 36.6 (mean) | 36.7 (mean) | ? | ? (31 - 40) | 37 (mean, N=25) |
| Birthweight, median (range) kilograms | 2.50 (mean) | 2.37 (1.29 - 3.47 | 2.56 | ? (1.5 - 2.5) | 2.46 (mean, N=25) |
| Antenatal diagnosis (N, %) | 51 (29%) | 89 (98%) | 21 (100%) | ? | ? |
| Inborn (N, %) | 0 (0%) | 81 (89%) | 17 (81%) | ? | ? |
| Caesarean section (N, %) | 68 (37%) | 24 (27%) | ? | 1 (7%) | 15 (52%) |
| Primary closure achieved at first procedure (N, %) | 131 (71%) | 72 (80%) | ? | 14 (100%) | 25 (86%) |
| Use of a silo (N, %) | 51 (29%) | 18 (20%) | ? | 0 (0%) | 4 (14%) |
| Required further surgery after primary procedure (N, %) | ? | ? | ? | 3 (21%) | 3 (10%) |
| Death prior to first procedure (N, %) | ? | 1 (1%) | ? | 0 (0%) | 0 (0%) |
| Overall mortality (N, %) | 17 (9%) | 7 (8%) | 2 (10%) | 2 (14%) | 0 (0%) |
| Duration of ventilatory support, median days | ? | 4.5 | ? | ? | ? |
| Time to full oral feeding, median (range) days | ? | 30 (5 - 160) | 24 | *Full feeds in 11 infants from 11 to 32 days, and in 8 infants by 18 days. | ? |
| Duration of TPN, median days | ? | ? | 23 | ? | 17 (mean) |
| Duration of hospital stay, median (range) days | 39.3 | 42 (11 - 183) | ? | ? | 20.5 (mean) |
Dr Paul Woodgate, MBBS MMedSci(Clin Epid) FRACP
Neonatal Paediatrician
Department of Neonatology
Mater Mothers Hospital
Raymond Terrace
South Brisbane
Queensland AUSTRALIA
4101
Telephone 1: +61-7-38401911
Facsimile: +61-7-38401949
E-mail: Paul_Woodgate@mater.org.au
| This review is published as a Cochrane review in
The Cochrane Library 2003, Issue 4, 2003 (see www.CochraneLibrary.net for
information). Cochrane reviews are regularly updated as new evidence
emerges and in response to comments and criticisms, and The Cochrane Library
should be consulted for the most recent version of the Review. |