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Completed

NCT Number: NCT03067038

Single Incision Versus Three Port Laparoscopic Cholecystectomy

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).

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preoperative diagnosis of symptomatic gallstones
  • age from 20 to 60 years,
  • American Society of Anesthesiologists (ASA) grade I, II or III,
  • agreement to complete the study requirement.

Exclusion criteria

  • patients with contraindication to laparoscopy,
  • suspected Mirizzi syndrome,
  • choledocholithiasis,
  • hepatobiliary malignancy,
  • previous upper abdominal surgery,
  • previous mesh repair of an umbilical hernia,
  • long-term anticoagulant treatment,
  • pregnant female
  • stone more than 2 cm in preoperative ultrasonography.

Treatment and study plan

Single incision laparoscopic cholecystectomy

Device

Laparoscopic cholecystectomy with single port device

Three port laparoscopic cholecystectomy

Device

Laparoscopic cholecystectomy with three port

Primary outcomes

  1. postoperative pain, visual analogue scale (VAS)

    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).

  2. postoperative pain, visual analogue scale (VAS)

    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).

Secondary outcomes

  1. operative duration

    Time frame: From introduction of first trocar to the recovery of patient, up to 10 hours

  2. post operative opioid requirements (questioner)

    Time frame: 24 hours

  3. lenght of hospital stay

    Time frame: from recovery of anaesthesia to discharge of patient, up to 4 days

  4. cosmetic satisfactions (aesthetic scale)

    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.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2017
Registry last updated
Mar 1, 2017

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.

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