An interventional study of SILC and LC in Cholelithiasis, Choledocholithiasis and Cholecystolithiasis, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-04-04.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment
This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.
As above
752 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
Subjects in this arm were randomized to undergo single-incision laparoscopic cholecystectomy, through a transumbilical incision
Procedure: SILC
Subjects in this arm were randomized to undergo conventional 4-port laparoscopic cholecystectomy. Wound sites at umbilicus, right hypocondrium, epigastrium and right flank
Procedure: LC
Underwent single-incision laparoscopic cholecystectomy
Also known as: Single-incision laparoscopic cholecystectomy
Underwent conventional 4-port laparoscopic cholecystectomy
Also known as: Conventional laparoscopic cholecystectomy
Post-operative pain 4 hours
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Time frame: 4 hours post-operative
Post-operative pain 24 hours
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Time frame: 24 hours post-operative
Post-operative pain 14 days
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Time frame: 14 days post-operative
Post-operative pain 6 months
To evaluate post-operative pain in single-incision laparoscopic cholecystectomy vs the conventional 4 port technique. Measured at both umbilical and extra-umbilical sites, at rest and on movement. Visual analogue scale, from 1-10.
Time frame: 6 months post-operative
Procedural complications
To evaluate complications between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Conducted via telephone interview and review of hospital records in the intervening period
Time frame: 6 months
Operative duration
To evaluate operative duration between single-incision laparoscopic cholecystectomy vs the conventional four port technique
Time frame: following skin closure
Subject satisfaction
To evaluate subject satisfaction between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured on a Likert scale, from 1-5 (1 least satisfied, 5 most satisfied)
Time frame: 14 days and 6 months
Return to function
To evaluate post-operative return to function following surgery, between single-incision laparoscopic cholecystectomy vs the conventional four port technique. Measured as days taken to independent toileting, and independently obtaining meals as a surrogate measure of function
Time frame: 14 days
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore