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Rekonstrukcija Roux‐en‐Y u odnosu na Billroth‐I nakon distalne gastrektomije zbog raka želuca

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Background

Gastric cancer is the fifth most common cancer diagnosed worldwide. Due to improved early detection rates of gastric cancer and technological advances in treatments, a significant improvement in survival rates has been achieved in people with cancer undergoing gastrectomy. Subsequently, there has been increasing emphasis on postgastrectomy syndrome (e.g. fullness, delayed emptying, and cold sweat, amongst others) and quality of life postsurgery. However, it is uncertain which types of reconstruction result in better outcomes postsurgery.

Objectives

To assess the evidence on health‐related quality of life and safety outcomes of Roux‐en‐Y and Billroth‐I reconstructions after distal gastrectomy for people with gastric cancer.

Search methods

We searched the Cochrane Library and the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase on 4 May 2021. We checked the reference lists of the included studies and contacted manufacturers and professionals in the field. There were no language restrictions.

Selection criteria

Randomised controlled trials (RCTs) allocating participants to Roux‐en‐Y reconstruction or Billroth‐I reconstruction after distal gastrectomy for gastric cancer.

Data collection and analysis

Two review authors independently screened studies identified by the search for eligibility and extracted data. The primary outcomes were health‐related quality of life after surgery and incidence of anastomotic leakage. The secondary outcomes included body weight loss, incidence of bile reflux, length of hospital stay, and overall morbidity. We used a random‐effects model to conduct meta‐analyses. We assessed risk of bias of the included studies in accordance with the Cochrane Handbook for Systematic Reviews of Interventions, and the certainty of the evidence using the GRADE approach.

Main results

We included eight RCTs (942 participants) in the review. One study included both cancer patients and benign disease patients such as stomach ulcers. Two studies compared Roux‐en‐Y, Billroth‐I, and Billroth‐II reconstructions, whilst the other studies compared Roux‐en‐Y and Billroth‐I directly. 

For the primary outcomes, the evidence suggests that there may be little to no difference in health‐related quality of life between Roux‐en‐Y and Billroth‐I reconstruction (standardised mean difference 0.04, 95% confidence interval (CI) −0.11 to 0.18; I² = 0%; 6 studies; 695 participants; low‐certainty evidence due to study limitations and imprecision). The evidence for the effect of Roux‐en‐Y versus Billroth‐I reconstruction on the incidence of anastomotic leakage is very uncertain (risk ratio (RR) 0.63, 95% CI 0.16 to 2.53; I² = 0%; 5 studies; 711 participants; very low‐certainty evidence). The incidence of anastomotic leakage was 0.6% and 1.4% in the Roux‐en‐Y and Billroth‐I groups, respectively.

For the secondary outcomes, the evidence suggests that Billroth‐I reconstruction may result in little to no difference in loss of body weight compared to Roux‐en‐Y reconstruction (mean difference (MD) 0.41, 95% CI −0.77 to 1.59; I² = 0%; 4 studies; 541 participants; low‐certainty evidence). Roux‐en‐Y reconstruction probably reduces the incidence of bile reflux compared to Billroth‐I reconstruction (RR 0.40, 95% CI 0.25 to 0.63; I² = 22%; 4 studies; 399 participants; moderate‐certainty evidence). Billroth‐I reconstruction may shorten postoperative hospital stay, but the evidence for this outcome is very uncertain (MD 0.96, 95% CI 0.16 to 1.76; I² = 56%; 7 studies; 894 participants; very low‐certainty evidence). Billroth‐I reconstruction may reduce postoperative overall morbidity compared to Roux‐en‐Y reconstruction (RR 1.47, 95% CI 1.02 to 2.11; I² = 0%; 7 studies; 891 participants; low‐certainty evidence).

Authors' conclusions

The evidence suggests that there is little to no difference between Roux‐en‐Y and Billroth‐I reconstruction for the outcome health‐related quality of life. The evidence for the effect of Roux‐en‐Y versus Billroth‐I reconstruction on the incidence of anastomotic leakage is very uncertain as the incidence of this outcome was low. Although the certainty of evidence was low, we found some possibly clinically meaningful differences between Roux‐en‐Y and Billroth‐I reconstruction for short‐term outcomes. Roux‐en‐Y reconstruction probably reduces the incidence of bile reflux into the remnant stomach compared to Billroth‐I reconstruction. Billroth‐I reconstruction may shorten postoperative hospital stay compared to Roux‐en‐Y reconstruction, but the evidence is very uncertain. Billroth‐I reconstruction may reduce postoperative overall morbidity compared to Roux‐en‐Y reconstruction. Future trials should include long‐term follow‐up of health‐related quality of life and body weight loss.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Rekonstrukcija Roux‐en‐Y u odnosu na Billroth‐I nakon operacije raka želuca

Cilj sustavnog pregleda

Pregledali smo dokaze o učinku Roux‐en‐Y u usporedbi s rekonstrukcijom Billroth‐I nakon operacije raka želuca. Pronašli smo osam ispitivanja.

Dosadašnje spoznaje

Rak želuca jedan je od najčešćih karcinoma u svijetu. Nedavno su se poboljšale stope ranog otkrivanja raka želuca i tehnologija liječenja. Kao rezultat toga, ljudi mogu dulje preživjeti nakon operacije, a raspravljalo se i o važnosti kvalitete života nakon operacije. Billroth‐I i Roux‐en‐Y su dvije opcije za rekonstrukciju kontinuiteta gastrointestinalnog sustava nakon distalne gastrektomije (uklanjanja donjeg dijela želuca).

Međutim, ne postoje standardi o tome koji rekonstruktivni postupak odabrati; smjernice ne opisuju koji bi postupak trebao biti prioritet. Stoga je bilo važno pogledati dostupne dokaze kako bi se pomoglo u donošenju odluka ljudima koji su podvrgnuti operaciji, kirurzima, liječnicima, medicinskom osoblju i kreatorima zdravstvene politike.

Značajke istraživanja

U ovaj su sustavni pregled uključeni dokazi objavljeni do 4. svibnja 2021. godine.

Pronašli smo osam ispitivanja koja su uključivala 942 sudionika s karcinomom želuca koji su bili podvrgnuti distalnoj gastrektomiji. Ispitivanja su bila provedena u četiri zemlje. Jedno ispitivanje uključivale je oboljele od raka i pacijente s drugim bolestima (kao što je čir na želucu). Dva ispitivanja uspoređivala su rekonstrukciju Roux‐en‐Y, Billroth‐I i Billroth‐II, dok su druga ispitivanja izravno uspoređivala Roux‐en‐Y i Billroth‐I. Što se tiče kirurških pristupa, u svim ispitivanjima korištena je otvorena ili laparoskopska kirurgija, ili oboje; robotska kirurgija nije korištena. Za mjerenje kvalitete života korišteno je šest različitih ljestvica.

Ključni rezultati

Dokazi sugeriraju da rekonstrukcija Roux‐en‐Y može malo ili nimalo utjecati na kvalitetu života 12 mjeseci nakon operacije. Međutim, ovi se nalazi moraju tumačiti s oprezom jer su istraživači kvalitetu života mjerili na različite načine. Dokazi su vrlo nesigurni za učinak intervencija na propuštanje kroz rekonstruirani spoj (anastomotsko curenje).

Billroth‐I rekonstrukcija može malo ili nimalo utjecati na gubitak tjelesne težine; vjerojatno povećava refluks žuči u ostatak želuca; i može smanjiti ukupne komplikacije nakon operacije u usporedbi s rekonstrukcijom Roux‐en‐Y. Dokazi su vrlo nesigurni za učinak na duljinu boravka u bolnici.

Pouzdanost dokaza

Pouzdanost dokaza o kvaliteti života bila je niska zbog ograničenja u načinu na koji su ispitivanja osmišljena i provedena te zato što nema dovoljno ispitivanja da bismo bili sigurni u rezultate za ovaj ishod. Pouzdanost dokaza za ostale ishode kretala se od vrlo niske do umjerene. Potrebna su daljnja istraživanja o ovom pitanju sa dužim razdobljem praćenja pacijenata.