Single incision laparoscopic cholecystectomy
DeviceLaparoscopic cholecystectomy with single port device
NCT Number: NCT03067038
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).
Looking for future studies?
Notify Me20 year–60 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic cholecystectomy with single port device
Laparoscopic cholecystectomy with three port
Time frame: at 6 hours
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative hour six (VAS-6H).
Time frame: at 24 hours
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative day one (VAS-24H).
Time frame: From introduction of first trocar to the recovery of patient, up to 10 hours
Time frame: 24 hours
Time frame: from recovery of anaesthesia to discharge of patient, up to 4 days
Time frame: one month
Patient aesthetic 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 aesthetic scale and were asked to rate their satisfaction based on the previous observation.
South Valley University
Other
Single Incision Versus Three Port Laparoscopic Cholecystectomy in Symptomatic Gallstones: A Prospective Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06755970
ICOUGH, Laparoscopic Cholecystectomy
Erzurum, Turkey (Türkiye)
View Trial DetailsNCT07707440
Anesthesia, General, Laparoscopic Cholecystectomy
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06476600
Laparoscopic Cholecystectomy, Surgical Procedure, Unspecified
Karachi, Sindh, Pakistan
View Trial DetailsNCT07332546
Laparoscopic Cholecystectomy, Neurologic Manifestations
Tianmen, Hubei, China
View Trial Details