Stapled or endloop closure of the appendiceal stump in laparoscopic appendectomy. A multicenter blinded randomised trial

Appendectomy for acute appendicitis is a high volume operation worldwide. In
the Netherlands only, 16,000 appendectomies are performed for acute
appendicitis.
Appendectomy is affecting particularly young patients and is mostly performed
by junior surgeons on call.
A trend towards an increasing penetration of the laparoscopic appendectomy is
apparent supported by the conclusions of the last update of the Cochrane review
on laparoscopic versus open appendectomy. 1
Although the surgical technique of laparoscopic appendectomy is well
established, controversy exists regarding the closure of the stump. In the
early days the appendix stump was closed using endoloops, while nowadays some
advocate the use of the much more expensive endostapler. The endostapler might
be associated with a shorter learning curve, shorter operating time, reduced
complexity of the procedure, less faecal spill and a more secure closure of the
appendix stump at the expense of higher costs of disposable instruments (+/-
700¤). The incidence of intra-abdominal abscesses (4.2%) and wound infections
(0.5%) is small but significant, and can lead to reinterventions, additional
treatment and prolonged hospital stay. Appendiceal stump closure might play a
role in the incidence of intra-abdominal abscesses. A systematic review
regarding this topic concluded that, based on three low quality studies, only
wound infection rate and postoperative ileus were reduced using endostaplers.
The overall reduction in morbidity and cost effectiveness remained to be
solved.
Findings have shown both techniques to be safe, but both entail potential
drawbacks. Linear staplers are expensive and require a 12-mm port for their
introduction. Metal staples on the stump and in the abdominal cavity can cause
adhesion-related short bowel obstruction or formation of pseudopolyps in the
caecum2-4.
On the other hand, loops are associated with more manipulation of the stump.
Moreover, they can slip, which can potentially lead to more postoperative
infections. Loops might be not safe for closure if the base of the appendix is
involved in the inflammation. If loops are too tight, they also can cut into
the tissue or cause local necrosis, predisposing to stump leakage.

Two published systematic reviews5,6 concluded that there is currently
insufficient evidence to choose one strategy above the other because the exact
balance between clinical effects and costs is unclear. In a cost-effectiveness
study alongside a randomised trial we will determine the clinical
effectiveness, quality of life and costs associated with both approaches.
The first objective is to determine whether the routine use of endostaplers for
closing the appendiceal stump will lead to a lower incidence of infectious
complications (intra-abdominal abscess, wound infection), compared to loop
closure. The second objective is to determine whether there is a difference in
health related quality of life between patients in both treatment groups.
Thirdly we aim to prove that endostapling is the easier approach in the sense
that it leads to fewer laparoscopic complications, fewer conversions to open
surgery, shorter operating time, and shorter hospital stay. As a fourth, the
cost effectiveness of both approaches will be calculated to prove that a
routine use of endostaplers for the appendiceal stump is more cost-effective
compared to loop closure by relating the incidence of infectious complications
with the associated direct and indirect costs.

The first objective is to determine whether the routine use of endostaplers for
closing the appendiceal stump will lead to a lower incidence of infectious
complications (intra-abdominal abscess, wound infection), compared to loop
closure. The second objective is to determine whether there is a difference in
health related quality of life between patients in both treatment groups.
Thirdly we aim to prove that endostapling is the easier approach in the sense
that it leads to fewer laparoscopic complications, fewer conversions to open
surgery, shorter operating time, and shorter hospital stay. As a fourth, the
cost effectiveness of both approaches will be calculated to prove that a
routine use of endostaplers for the appendiceal stump is more cost-effective
compared to loop closure by relating the incidence of infectious complications
with the associated direct and indirect costs.

The cost-effectiveness of laparoscopic appendectomy by both approaches will be
studied in a randomised multicenter study. Patients eligible for laparoscopic
appendectomy fulfilling the in- and exclusioncriteria are randomised
intraoperatively via the trial website for either loop or endostapler closure
of the appendix stump. The trial can be performed in a blinded setting. The
operating team is the only one that knows what technique has been applied.
Nursing and medical staff are blinded for the type of appendix closure.

Laparoscopic appendectomy with either stomp closure with use of the endostapler
or with the use of endoloops. The procedure is performed according to the Best
Practice Guidelines of the Working Group Endoscopic surgery. In the stapling
group one 11-12mm disposable trocar and endostapler is required additionally.

Not applicable