Laparoscopic Cholecystectomy Clinical Trial
Official title:
Single Incision Versus Three Port Laparoscopic Cholecystectomy in Symptomatic Gallstones: A Prospective Randomized Study
Laparoscopic cholecystectomy (LC) became the standard treatment for symptomatic gallbladder disease. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. The aim of this study was to compare the clinical outcome of single-incision laparoscopic cholecystectomy (SILC) with three port laparoscopic cholecystectomy (TPLC).
From February 2014 to September 2016, patients with symptomatic cholecystolithiasis at two
university hospitals (Sohag University and Qena University hospitals) were enrolled in this
study.
The number of patients needed was calculated. Considering a power of 80% and reliability of
0.05, the investigator found that 76 patients should be present in each group. The study was
started with 275 patients for the possible loss of patients and data during the study.
Eligible patients (206 patients) were randomly divided equally into two groups (Group 1;
SILC, Group 2; TPLC) according to a computer-generated random numbers. Of 103 patients
allocated to intervention in each group, 14 patients were excluded from SILC group and 5
patients from TPLC group, and the remaining 89 & 98 patients in SILC & TPLC group
respectively were included in the study.
Routine investigations and surgical fitness were done in all cases. Patient demographics,
BMI, ASA score, indication for cholecystectomy, operative time, estimated blood loss,
success and conversion rate, postoperative pain score, postoperative analgesia requirement,
morbidity and mortality, length of hospital stay, and patient cosmetic satisfaction were
recorded.
A fixed analgesia protocol with intravenous non-narcotic (ketorolac tromethamine 30 mg) was
used twice daily. An opioid (pethidine Hcl 50 mg) was added when the pain cannot be
tolerable. Postoperative pain was evaluated according to a visual analogue scale (VAS) from
0 (no pain) to 10 (maximum pain) on the postoperative sixth hour (VAS-6H) and on
postoperative day one (VAS-24H). Patient cosmetic satisfaction was recorded at one month
follow-up visit on a scale from 1 (worst) to 10 (best). Patients were shown the same
photograph of a right sub-costal (Kocher) incision which was rated 0 on the cosmetic scale
and were asked to rate their satisfaction based on the previous observation. The study
protocol was approved by the local ethical committee. Also, a written informed consent was
obtained from all patients' prior recruitment to study.
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