Single Incision Versus Three Port Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Single Incision Versus Three Port Laparoscopic Cholecystectomy in Symptomatic Gallstones: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067038
• Other study ID #: SVU
• Status: Completed
• Phase: N/A
• First received: November 25, 2016
• Last updated: February 23, 2017
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. preoperative diagnosis of symptomatic gallstones

2. age from 20 to 60 years,

3. American Society of Anesthesiologists (ASA) grade I, II or III,

4. agreement to complete the study requirement.

Exclusion Criteria:

1. patients with contraindication to laparoscopy,

2. suspected Mirizzi syndrome,

3. choledocholithiasis,

4. hepatobiliary malignancy,

5. previous upper abdominal surgery,

6. previous mesh repair of an umbilical hernia,

7. long-term anticoagulant treatment,

8. pregnant female

9. stone more than 2 cm in preoperative ultrasonography.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Device:
• Single incision laparoscopic cholecystectomy
Laparoscopic cholecystectomy with single port device
• Three port laparoscopic cholecystectomy
Laparoscopic cholecystectomy with three port

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain, visual analogue scale (VAS)	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).	at 6 hours
Primary	postoperative pain, visual analogue scale (VAS)	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).	at 24 hours
Secondary	operative duration		From introduction of first trocar to the recovery of patient, up to 10 hours
Secondary	post operative opioid requirements (questioner)		24 hours
Secondary	lenght of hospital stay		from recovery of anaesthesia to discharge of patient, up to 4 days
Secondary	cosmetic satisfactions (aesthetic scale)	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.	one month