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Evidence - Cholecystectomy, open

  1. Summary of the Literature

    Therapy of asymptomatic cholecystolithiasis

    After diagnosis of asymptomatic cholecystolithiasis, the risk of developing symptoms is 2-4% per year in the first 5 years and then halves. The risk of biliary complications is only 0.1-0.3% per year [1]. A prophylactic cholecystectomy does not increase life expectancy in asymptomatic stone carriers, as the surgical risk outweighs the probability of developing biliary complications [2]. Various guidelines therefore agree that asymptomatic cholecystolithiasis generally does not represent an indication for surgery [3, 4, 5].

    A special case is asymptomatic stone carriers with gallbladder concretions > 3 cm. According to the German S3 guideline 2017, cholecystectomy should be considered in these cases, as the risk of developing gallbladder carcinoma is increased up to 10-fold [6].

    Recommendation for asymptomatic stone carriers in the context of obesity surgery

    The German S3 guideline 2017 recommends performing a cholecystectomy in the context of obesity surgery only in symptomatic stone carriers [4]. The EASL guidelines 2016 agree with the S3 guideline in this regard, but only at a very low level of evidence [5]. This is reflected in the S3 guideline in a second statement on this topic, according to which a simultaneous cholecystectomy can be performed in asymptomatic patients during major malabsorptive procedures on the small intestine.

    Compared to sleeve resection and gastric banding, laparoscopic Roux-en-Y reconstruction has the highest risk of postoperative gallstone formation [7]. The recommendation that simultaneous cholecystectomy should only be performed in symptomatic stone carriers is reflected in a registry study and a meta-analysis [8, 9]. The probability of a secondary cholecystectomy was low in these studies after laparoscopic Roux-en-Y reconstruction at 6.8%, and in 5.3% of cases this was due to symptomatic cholecystolithiasis. The secondary cholecystectomy was performed almost always (95.5%) laparoscopically with a very low morbidity (1.8%).

    Therapy of symptomatic cholecystolithiasis

    There is a consensus among all professional societies regarding the therapy of symptomatic cholecystolithiasis. Thus, the German S3 guideline 2017 recommends cholecystectomy for uncomplicated cholecystolithiasis with typical biliary pain [4].

    The goal of cholecystectomy is to prevent recurrent biliary symptoms and later complications as well as to prevent gallbladder carcinoma. Untreated patients develop colic again in about 70% of cases within the following 2 years, and 4% require acute cholecystectomy [10]. The risk of biliary complications is 1-3% per year. If the patient is symptom-free for 5 years, he is considered an asymptomatic stone carrier again and does not need to undergo cholecystectomy [11]. For gallbladder sludge, the German S3 guideline recommends the same procedure as for symptomatic cholecystolithiasis [4]. Conservative-medical therapy or lithotripsy is obsolete nowadays [3].

    Antibiotic prophylaxis in elective cholecystectomy

    All of the above guidelines agree that in low-risk patients, no prophylactic antibiotic administration is necessary during elective cholecystectomy. There is no prospective, randomized study with sufficiently large patient numbers to clarify the question, but several meta-analyses, registry data from Germany and Sweden, and a Cochrane review [12, 13].

    The SAGES guidelines make the same statement for low-risk patients, elaborating on this point further [14]:

    • In high-risk patients (age > 60 years, diabetics, biliary colic within the last 30 days before surgery, jaundice, cholangitis or acute cholecystitis), the administration of antibiotics can reduce the rate of wound infections.
    • If antibiotic prophylaxis is performed, it should be done 1 hour before skin incision.
    • In open cholecystectomy or conversion from laparoscopic to open procedure, the wound infection rate can be reduced from 15 to 6% [13].

    Recommendation for porcelain gallbladder

    For the development of gallbladder carcinoma in calcified gallbladders, a risk of up to 62% has been reported in the past. According to newer studies, this number is too high [15, 16]. Nevertheless, it is recommended to prophylactically cholecystectomize asymptomatic patients with porcelain gallbladder [4, 5, 14].

    Recommendation for the treatment of gallbladder polyps

    The incidence of gallbladder polyps in Germany is about 6% [17]. The frequency of adenomas in these patients is about 5%. Adenomas > 1 cm in size contain carcinoma in up to 50% of cases, which is why these patients should be prophylactically cholecystectomized [18]. In even larger adenomas (1.8-2 cm), the carcinoma incidence increases even further, which is why primary open cholecystectomy should be performed from an oncological point of view [19].

    Gallbladder polyps < 1 cm in size have a significantly lower risk of degeneration, so that although immediate cholecystectomy is not necessary, the patients must be regularly monitored sonographically [19]. If the patients develop biliary symptoms or further risk factors (age > 50 years, solitary polyps, gallstones, rapidly growing polyps), the indication for surgery is given [18, 20].

    Endosonography is superior to transcutaneous sonography for the diagnosis of gallbladder polyps (87–97% versus 52–76%) [21].

    The SAGES guidelines from 2010 recommend laparoscopic cholecystectomy for the treatment of gallbladder polyps in patients with large, singular polyps or in patients with concomitant symptoms. A “wait-and-watch strategy” is recommended for patients with small polyps (< 5 mm) [14].

    The EASL guidelines from 2016 elaborate on the recommendations [5]:

    • Cholecystectomy in patients with gallbladder polyps > 1 cm regardless of symptoms and independent of the presence of gallstones
    • Cholecystectomy in patients with primary sclerosing cholangitis and gallbladder polyps
    • No cholecystectomy in asymptomatic cholecystolithiasis and small polyps (< 5 mm)

    The German S3 guideline recommends cholecystectomy only in patients with cholecystolithiasis and gallbladder polyps ≥ 1 cm independent of symptomatology [4].

    Recommendation for laparoscopy in liver cirrhosis Child-Pugh A and B

    Patients with liver cirrhosis are predisposed to the development of cholecystolithiasis. Studies have shown acceptable morbidity (9.5-23%) and mortality (0-6.3%) for laparoscopic cholecystectomy in Child-Pugh A and B patients. A prospective randomized study showed superiority of the laparoscopic technique over the open one [22]. Laparoscopic cholecystectomy is not recommended for Child-C patients.

    The above guidelines agree on this with different levels of evidence and grades of recommendation.

    Recommendations for the therapy of acute cholecystitis

    The most common complication of cholecystolithiasis is acute cholecystitis, which in > 90% of cases is caused by a transient or permanent outflow obstruction due to concretions in the cystic duct. In these cases, laparoscopic cholecystectomy is performed as standard.

    The recommendations of the various guidelines on the optimal timing of cholecystectomy after diagnosis of acute cholecystitis are as follows:

    • German S3 guideline [4]

    Acute cholecystitis is an indication for early laparoscopic cholecystectomy. This should be performed within 24 h after hospital admission.

    • EASL [5]

    An early cholecystectomy (preferably within 72 h after admission) should be performed by an experienced surgeon.

    • SAGES [14]

    Early cholecystectomy (within 24–72 h after diagnosis) can be performed without an increased conversion rate to an open procedure and without an increased risk of complications and can reduce both hospital costs and length of stay.

    • Tokyo [23]

    Determination of the therapy strategy after determining the severity of acute cholecystitis. For both grade I (mild) and II (moderate), laparoscopic cholecystectomy should ideally be performed promptly after onset of symptoms if the patient tolerates surgery. In case of severe inflammation (grade III), organ function should first be secured.

    The Tokyo Guidelines from 2013 have been criticized by many professional societies as too conservative and not up-to-date [24,25]. Based on the current literature, immediate cholecystectomy within 24–48 h is associated with a clear benefit for the patient, which is withheld from grade II patients according to the treatment recommendations of the Tokyo Guidelines 2013.

    Recommendation for gallbladder carcinoma, carcinoma in situ (Tis) and mucosal carcinoma (T1a)

    Incidental gallbladder carcinomas are found in less than 1% of cholecystectomy specimens. For further therapy, the T stage is decisive, which is why the German S3 guideline, in agreement with the SAGES guidelines, states that removal of the gallbladder is sufficient for carcinoma in situ (Tis) or mucosal carcinoma (T1a) [5, 14].

    In the aforementioned early tumor stages, there is neither lymphatic nor perineural spread [26]. Thus, liver partial resection or lymphadenectomy is not indicated. For all tumor stages ≥ T1b, oncological re-resection should be performed with curative intent (wedge resection with 2-3 cm liver cuff resection). If R0 status is achieved, the results after 4 years are very good [26].

    Recommendation for laparoscopic cholecystectomy in pregnancy

    Gallstones and sludge form in about 5% of all pregnant women with about 1% gallstone-associated complications still during pregnancy [27]. If conservative management is used, 92% of patients in the first trimester experience recurrent symptoms, 64% in the second trimester, and 44% in the third trimester. Fetal lethality due to biliary complications is 12-60% and thus significantly higher than due to indicated laparoscopic cholecystectomy (1.2%). Regarding fetal mortality or preterm birth rate, the current study situation shows no significant differences between open or laparoscopic cholecystectomy (5% vs. 4%) [28].

    The German S3 guideline recommends regarding laparoscopic cholecystectomy during pregnancy that the procedure can be performed in any trimester if there is an urgent indication. Furthermore, patients who have already become symptomatic in the 1st trimester should be operated on early electively due to significant risk of recurrence in the further course of pregnancy [5].

    This statement is confirmed by the SAGES guidelines on diagnosis, treatment and use of laparoscopy during pregnancy:

    • For acute abdominal processes, diagnostic laparoscopy is also a safe and effective option during pregnancy.
    • Laparoscopic cholecystectomy is the treatment of choice for pregnant patients with gallstone disease regardless of trimester.
    • The same indications for laparoscopic treatment of acute abdominal diseases apply to pregnant patients as to non-pregnant ones.
    • Laparoscopy can be performed safely in any trimester.

    Recommendation for access techniques of laparoscopic cholecystectomy

    A laparoscopic operation is generally the standard procedure for cholecystectomy. Both the German S3 guideline and the EASL and SAGES guidelines make recommendations for the type of laparoscopic access. While the SAGES guideline makes rather vague statements, the S3 and EASL guidelines are specific in that laparoscopic cholecystectomy should be performed in a 4-trocar technique [4, 5, 14].

    Currently, there are no large, randomized studies that demonstrate an advantage for single-incision (SILS) or natural orifice transluminal endoscopic surgery (NOTES), so these techniques cannot currently be recommended as standard. Operative time and complication rate depend heavily on the surgeon's experience, and postoperative pain is not significantly reduced by either the SILS technique or the NOTES procedure [29, 30].

  2. Currently ongoing studies on this topic

  3. Literature on this topic

    1. Attili AF, De Santis A, Capri R et al (1995) The natural history of gallstones: the GREPCO experience. Hepatology 21:655–660

    2. Festi D, Reggiani ML, Attili AF, Loria P, Pazzi P, Scaioli E, Capodicasa S, Romano F, Roda E, Colecchia A (2010) Natural history of gallstone disease: Expectant management or active treatment? Results from a population-based cohort study. J Gastroenterol Hepatol 25:719–724

    3. Lammert et al (2016) EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol 65(1):146–181

    4. S3 Guideline of the German Society for Digestive and Metabolic Diseases and the German Society for Visceral Surgery on the Diagnosis and Treatment of Gallstones. AWMF Register No. 021/008. Revised version: As of June 2017

    5. EASL (2016) Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones, J Hepatol 65(1):146–181

    6. Cariati A, Piromalli E, Cetta F (2014) Gallbladder cancers: associated conditions, histological types, prognosis, and prevention. Eur J Gastroenterol Hepatol 26(5):562–569

    7. Tsirline V B, Keilani Z M, El Djouzi S, Phillips R C, Kuwada T S, Gersin K, Simms C, Stefanidis D (2014) How frequently and when do patients undergo cholecystectomy after bariatric surgery? Surg Obes Relat Dis 10(2):313–321

    8. Worni M, Guller U, Shah A, Gandhi M, Shah J, Rajgor D, Pietrobon R, Jacobs D O, Ostbye T (2012) Cholecystectomy concomitant with laparoscopic gastric bypass: a trend analysis of the nationwide inpatient sample from 2001 to 2008. Obes Surg 22(2):220–229

    9. Warschkow R, Tarantino I, Ukegjini K, Beutner U, Guller U, Schmied B M, Muller S A, Schultes B, Thurnheer M (2013) Concomitant cholecystectomy during laparoscopic Roux- en-Y gastric bypass in obese patients is not justified: a meta-analysis. Obes Surg 23(3), 397–407

    10. Thistle JL, Cleary PA, Lachin JM, Tyor MP, Hersh T (1984) The natural history of cholelithiasis: the National Cooperative Gallstone Study. Ann Intern Med 101:171–175

    11. Friedman G D, Raviola C A, Fireman B (1989) Prognosis of gallstones with mild or no symptoms: 25 years of follow-up in a health maintenance organization. J Clin Epidemiol 42(2):127–136

    12. Yan R C, Shen S Q, Chen Z B, Lin F S, Riley J (2011) The role of prophylactic antibiotics in laparoscopic cholecystectomy in preventing postoperative infection: a meta-analysis. J Laparoendosc Adv Surg Tech A 21(4):301–306

    13. Sanabria A, Dominguez LC, Valdivieso E, Gomez G (2010) Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev (12):CD005265

    14. Overby DW, Apelgren KN, Richardson W, Fanelli R, Society of American Gastrointestinal and Endoscopic Surgeons (2010) SAGES guidelines for the clinical application of laparoscopic biliar tract surgery. Surg Endosc 24(10):2368–2386

    15. Stephen AE, Berger DL (2001) Carcinoma in the porcelain gallbladder: a relationship revisited. Surgery 129:699–703

    16. Kwon AH, Inui H, Matsui Y, Uchida Y, Hukui J, Kamiyama Y (2004) Laparoscopic cholecystectomy in patients with porcelain gallbladder based on the preoperative ultrasound findings. Hepatogastroenterology 51:950–953

    17. Heyder N, Gunter E, Giedl J, Obenauf A, Hahn EG (1990) Polypoid lesions of the gallbladder. Dtsch Med Wochenschr 115:243–247

    18. Okamoto M, Okamoto H, Kitahara F, Kobayashi K, Karikome K, Miura K, Matsumoto Y, Fujino M A (1999) Ultrasonographic evidence of association of polyps and stones with gallbladder cancer. Am J Gastroenterol 94(2):446–450

    19. Lee KF, Wong J, Li JC, Lai PB (2004) Polypoid lesions of the gallbladder. Am J Surg 188(2),186–190

    20. Matos AS, Baptista HN, Pinheiro C, Martinho F (2010) Gallbladder polyps: how should they be treated and when? Rev Assoc Med Bras 56(3):318–21

    21. Azuma T, Yoshikawa T, Araida T, Takasaki K (2001) Differential diagnosis of polypoid lesions of the gallbladder by endoscopic ultrasonography. Am J Surg 181(1):65–70

    22. Ji W, Li LT, Wang ZM, Quan ZF, Chen XR, Li JS (2005) A randomized controlled trial of laparoscopic versus open cholecystectomy in patients with cirrhotic portal hypertension. World J Gastroenterol 11:2513–2517

    23. Takada T, Strasberg SM, Solomkin JS et al.; Tokyo Guidelines Revision Committee (2013)TG13: Updated Tokyo Guidelines for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci 20(1):1–7

    24. Overby DW, Apelgren KN, Richardson W, Fanelli R, Society of American Gastrointestinal and Endoscopic Surgeons (2010) SAGES guidelines for the clinical application of laparoscopic biliar tract surgery. Surg Endosc 24(10):2368–2386

    25. Agresta F, Ansaloni L, Baiocchi GL, Bergamini C, Campanile FC, Carlucci M et al (2012) Laparoscopic approach to acute abdomen from the Consensus Development Conference of the Societá Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE), Associazione Chirurghi Ospedalieri Italiani (ACOI), Società Italiana di Chirurgia (SIC), Società die Chirurgia d´Urgenza e del Trauma (SICUT), Società Italiana di Chirurgia nell´Ospedalità Privata (SICOP), and the European Association for Endoscopic Surgery (EAES). Surg Endosc 26(8):2134–2164

    26. Goetze T O, Paolucci V (2014) [Incidental T1b-T3 gallbladder carcinoma Extended cholecystectomy as an underestimated prognostic factor-results of the German registry]. Chirurg 85(2):131–138

    27. Ko C W (2006) Risk factors for gallstone-related hospitalization during pregnancy and the postpartum. Am J Gastroenterol 101(10):2263–2268

    28. Date RS, Kaushal M, Ramesh A (2008) A review of the management of gallstone disease and its complications in pregnancy. Am J Surg 196(4):599–608

    29. Borchert D H, Federlein M, Fritze-Buttner F, Burghardt J, Liersch-Lohn B, Atas Y, Muller V, Ruckbeil O, Wagenpfeil S, Graber S, Gellert K (2014) Postoperative pain after transvaginal cholecystectomy: single-center, double-blind, randomized controlled trial. Surg Endosc 28(6): 1886–1894

    30. Luna, R A, Nogueira, D B, Varela, P S, Rodrigues Neto, Ede O, Norton, M J, Ribeiro, Ldo C, Peixoto, A M, de Mendonca, Y L, Bendet, I, Fiorelli, R A, Dolan, J P (2013) A prospective, randomized comparison of pain, inflammatory response, and short-term outcomes between single port and laparoscopic cholecystectomy. Surg Endosc 27(4):1254–1259

  4. Reviews

    Sanford DE. An Update on Technical Aspects of Cholecystectomy. Surg Clin North Am. 2019 Apr;99(2):245-258.

    Gupta V, Jain G. Safe laparoscopic cholecystectomy: Adoption of universal culture of safety in cholecystectomy. World J Gastrointest Surg. 2019 Feb 27;11(2):62-84.

    Gunnarsson R, de Costa A. Selective Cholecystectomy: using an evidence-based prediction model to plan for cholecystectomy. ANZ J Surg. 2019 May;89(5):488-491.

    Sun N, Zhang JL, Zhang CS, Li XH, Shi Y. Single-incision robotic cholecystectomy  versus single-incision laparoscopic cholecystectomy: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(36):e12103

    Thangavelu A, Rosenbaum S, Thangavelu D. Timing of Cholecystectomy in Acute Cholecystitis. J Emerg Med. 2018 Jun;54(6):892-897.

    Lamberts MP. Indications of cholecystectomy in gallstone disease. Curr Opin Gastroenterol. 2018 Mar;34(2):97-102.

    Wakabayashi G, Iwashita Y, Hibi T, Takada T, Strasberg SM, Asbun HJ, Endo I, Umezawa A, Asai K, Suzuki K, Mori Y, Okamoto K, Pitt HA, Han HS, Hwang TL, Yoon YS, Yoon DS, Choi IS, Huang WS, Giménez ME, Garden OJ, Gouma DJ, et al. Tokyo Guidelines 2018: surgical management of acute cholecystitis: safe steps in laparoscopic cholecystectomy for acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):73-86

    Conrad C, Wakabayashi G, Asbun HJ, Dallemagne B, Demartines N, Diana M, Fuks D, Giménez ME, Goumard C, Kaneko H, Memeo R, Resende A, Scatton O, Schneck AS, Soubrane O, Tanabe M, van den Bos J, Weiss H, Yamamoto M, Marescaux J, Pessaux P. IRCAD recommendation on safe laparoscopic cholecystectomy. J Hepatobiliary Pancreat Sci. 2017 Nov;24(11):603-615. Review. PubMed [citation] PMID: 29076265

    Hassler KR, Collins JT, Philip K, Jones MW. Laparoscopic Cholecystectomy. 2020 Oct 1. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan

    Tan X, Wang G, Tang Y, Bai J, Tao K, Ye L. Minilaparoscopic versus single incision cholecystectomy for the treatment of cholecystolithiasis: a meta-analysis and systematic review. BMC Surg. 2017 Aug 22;17(1):91.

    Lirici MM, Tierno SM, Ponzano C. Single-incision laparoscopic cholecystectomy: does it work? A systematic review. Surg Endosc. 2016 Oct;30(10):4389-99.

  5. Guidelines

  6. literature search

    Literature search on the pages of pubmed.