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. 2013 Aug 31;2013(8):CD006574. doi: 10.1002/14651858.CD006574.pub4

Larsen 2001.

Methods Randomised clinical trial.
Participants Country: Denmark.
 Number randomised: 50.
 Mean age: 51 years.
 Females: 35 (70%).
Inclusion criteria:
  1. Elective participants

  2. ASA I or II

  3. > 18 years

  4. BMI of 30 or less.


Exclusion criteria:
  1. Acute pancreatitis

  2. Cholecystitis

  3. Cholangitis

  4. Blood diseases

  5. Rheumatic diseases

  6. Acute infectious diseases

  7. Renal diseases

  8. Liver diseases.

Interventions Participants were randomly assigned to two groups:
Group 1: abdominal wall lift (n = 24).
 Group 2: pneumoperitoneum with 12 mm Hg pressure (n = 26).
Device used for abdominal lift: subcutaneous device.
Outcomes The main outcome measures were complications, conversion to open cholecystectomy, and operating time.
Notes One cross‐over from abdominal wall lift to control group because of poor visualisation.
Attempts were made to contact the author in February 2007.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The allocation sequence was generated by random numbers".
Allocation concealment (selection bias) Unclear risk Quote: "Patients were allocated randomly to the two groups by opening sealed envelopes on the day of operation."
Comment: Further information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "The intervention assignments were concealed from the patients and the ward nursing staff."
Comment: It was not clear whether the other healthcare providers were blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "The intervention assignments were concealed from the patients and the ward nursing staff."
Comment: It was not clear whether the other healthcare providers were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: There were postrandomisation drop‐outs.
Selective reporting (reporting bias) High risk Comment: Important outcomes were not reported.
Vested interest bias Unclear risk Quote: "This study was supported by grants from Nordjyllands Amts Forskningsrád, Aalborgs Stifts Julelotteri and Det Obelske Familiefond."
Comment: Not clear whether these were the only sources of support.