Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03067038
Study type Interventional
Source South Valley University
Contact
Status Completed
Phase N/A
Start date October 2014
Completion date October 2016

See also
  Status Clinical Trial Phase
Completed NCT03670849 - Image Fusion in the OR N/A
Withdrawn NCT04561583 - Effectiveness and Safety of LED Light Source System for Endoscope N/A
Completed NCT00872287 - Pain in Single Incision Laparoscopic Surgery Cholecystectomy Phase 4
Recruiting NCT06017167 - Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy Phase 2
Completed NCT05536557 - Bilateral External Oblique Ä°ntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy. N/A
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Completed NCT05998317 - Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy Phase 2/Phase 3
Completed NCT04759079 - The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy N/A
Recruiting NCT04138472 - Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy N/A
Recruiting NCT06022926 - Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy N/A
Completed NCT02469831 - Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy Phase 2
Completed NCT00886210 - Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy N/A
Completed NCT00292214 - Comparing Intravenous and Oral Paracetamol for Cholecystectomy Phase 4
Recruiting NCT05533567 - Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol N/A
Recruiting NCT05533580 - Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia N/A
Active, not recruiting NCT05636475 - The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery N/A
Recruiting NCT05094193 - Trocar-site Infiltration Versus TAP-block N/A
Completed NCT03323684 - Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia N/A
Recruiting NCT04162106 - Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS N/A
Unknown status NCT01041183 - The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy N/A