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Randomized Controlled Trial
. 2008 Jul;22(7):1649-59.
doi: 10.1007/s00464-007-9675-0. Epub 2007 Dec 11.

Laparoscopic versus small-incision cholecystectomy: health status in a blind randomised trial

Frederik Keus  1 , Jolanda de Vries, Hein G Gooszen, Cornelis J H M van Laarhoven
Affiliations
Randomized Controlled Trial

Laparoscopic versus small-incision cholecystectomy: health status in a blind randomised trial

Frederik Keus et al. Surg Endosc. 2008 Jul.

Abstract

Background: Gallstones are a major cause of morbidity, and cholecystectomy is a commonly performed procedure. Minimal invasive procedures, laparoscopic cholecystectomy (LC) and small-incision cholecystectomy (SIC), have replaced the classical open cholecystectomy. No differences have been found in primary outcome measures between LC and SIC, therefore secondary outcome measures have to be considered to determine preferences. The aim of our study was to examine health status applying evidence-based guidelines in LC and SIC in a randomised trial.

Methods: Patients with symptomatic cholecystolithiasis were included in a blind randomised trial. Operative procedures, anaesthesia, analgesics and postoperative care were standardised in order to limit bias. Questionnaires were filled in preoperatively, the first day postoperatively, and at outpatients follow-up at 2, 6 and 12 weeks. In accordance with evidence-based guidelines, the generic short form (SF-36) and the disease-specific gastrointestinal quality-of-life index (GIQLI) questionnaires were used in addition to the body image questionnaire (BIQ).

Results: A total of 257 patients were randomised between LC (120) and SIC (137). Analyses were performed according to intention-to-treat (converted procedures included) and also distinguishing converted from minimal invasive (nonconverted) procedures. Questionnaires were obtained with a response rate varying from 87.5% preoperatively to 77.4% three months postoperatively. Except for two time-specific measurements in one SF-36 subscale, there were no differences between LC and SIC. There were significant differences in several subscales in all three questionnaires comparing minimal invasive versus converted procedures.

Conclusions: Applying adequate methodological quality and evidence-based guidelines (by using SF-36 and GIQLI), there are no significant differences in health status between LC and SIC.

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Figures

Fig. 1
Fig. 1
Revised consort statement diagram showing the flow of participants through each stage of the randomised trial [38]
See this image and copyright information in PMC

References

    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1001/jama.270.12.1429', 'is_inner': False, 'url': 'https://doi.org/10.1001/jama.270.12.1429'}, {'type': 'PubMed', 'value': '8371441', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/8371441/'}]}
    2. Legorreta AP, Silber JH, Costantino GN, Kobylinski RW, Zatz SL (1993) Increased cholecystectomy rate after the introduction of laparoscopic cholecystectomy. JAMA 270:1429–1432 - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1056/NEJM199402103300607', 'is_inner': False, 'url': 'https://doi.org/10.1056/nejm199402103300607'}, {'type': 'PubMed', 'value': '8284007', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/8284007/'}]}
    2. Steiner CA, Bass EB, Talamini MA, Pitt HA, Steinberg EP (1994) Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland. N Engl J Med 330:403–408 - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1001/jama.269.8.1018', 'is_inner': False, 'url': 'https://doi.org/10.1001/jama.269.8.1018'}, {'type': 'PubMed', 'value': '8429583', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/8429583/'}]}
    2. NIH Consensus conference (1993) Gallstones and laparoscopic cholecystectomy. JAMA 269:1018–1024 - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1016/0002-9610(91)90592-2', 'is_inner': False, 'url': 'https://doi.org/10.1016/0002-9610(91)90592-2'}, {'type': 'PubMed', 'value': '1825754', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/1825754/'}]}
    2. Olsen DO (1991) Laparoscopic cholecystectomy. Am J Surg 161:339–344 - PubMed
    1. {'text': '', 'ref_index': 1, 'ids': [{'type': 'DOI', 'value': '10.1097/00000658-199308000-00003', 'is_inner': False, 'url': 'https://doi.org/10.1097/00000658-199308000-00003'}, {'type': 'PMC', 'value': 'PMC1242921', 'is_inner': False, 'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC1242921/'}, {'type': 'PubMed', 'value': '8342992', 'is_inner': True, 'url': 'https://pubmed.ncbi.nlm.nih.gov/8342992/'}]}
    2. Roslyn JJ, Binns GS, Hughes EF, Saunders-Kirkwood K, Zinner MJ, Cates JA (1993) Open cholecystectomy. A contemporary analysis of 42,474 patients. Ann Surg 218:129–137 - PMC - PubMed

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