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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain, Postoperative Gallstone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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transumbilical wound

transumbilical incision

Group Type EXPERIMENTAL

transumbilical incision

Intervention Type PROCEDURE

incision within umbilicus

infra umbilical wound

infra umbilical incision

Group Type ACTIVE_COMPARATOR

Infra umbilical incision

Intervention Type PROCEDURE

incision about 1 cm below umbilicus

Interventions

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transumbilical incision

incision within umbilicus

Intervention Type PROCEDURE

Infra umbilical incision

incision about 1 cm below umbilicus

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No