Single Incision Versus Three Port Laparoscopic Cholecystectomy
Condition: Laparoscopic Cholecystectomy
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Single incision laparoscopic cholecystectomy; Three port laparoscopic cholecystectomy
Intervention type(s): Device; Device
Intervention description(s): Laparoscopic cholecystectomy with single port device; Laparoscopic cholecystectomy with three port
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment