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Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02738710
Enrollment
102
Registered
2016-04-14
Start date
2016-09-30
Completion date
2017-11-30
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallstone, Pain, Postoperative

Brief summary

This study compare outcomes (i.e. pain, wound infection, and patient satisfaction) between infra-umbilical vs. trans-umbilical incision after Laparoscopic cholecystectomy

Detailed description

Infra-umbilical wound have been used for a while with aim at improving cosmoses of the incision. Formerly, standard incision for laparoscopic cholecystectomy was infra-umbilical wound. However, no study directly compare these types of incisions in term of postoperative pain, wound infection, and patient satisfaction.

Interventions

incision within umbilicus

PROCEDUREInfra umbilical incision

incision about 1 cm below umbilicus

Sponsors

Thammasat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* elective laparoscopic cholecystectomy * willing to participate

Exclusion criteria

* pregnancy * immunocompromised host * on continuous ambulatory peritoneal dialysis * morbid obesity (Body mass index \> 35 kg/m2) * End-stage renal disease with hemodialysis dependent * ascites * uncontrolled coagulopathy

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain7 days postoperativelyvisual analog scale (0-10)

Secondary

MeasureTime frameDescription
wound infectionat 1 week and 1 month postoperativelyyes or no according to Center for Disease Control and Prevention (CDC) criteria
patient satisfaction1 week and 3 months postoperativelyVisual analog scale (0-10)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026