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Assessment of laparoscopic hole during and after removal of gallbladder from upper abdominal hole or navel hole in laparoscopic gallbladder removal surgery - patient and investigator are made not aware that through which hole gallbladder will be removed.

PERIOPERATIVE PORT-SITE MORBIDITY FOLLOWING EXTRACTION OF GALLBLADDER FROM EPIGASTRIC OR UMBILICAL PORT IN LAPAROSCOPIC CHOLECYSTECTOMY - A DOUBLE BLINDED RANDOMIZED CONTROL TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005732
Enrollment
60
Registered
2015-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- THOSE PATIENTS WHO ARE FIT FOR SURGERY (ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY) UNDER GA

Interventions

Intervention1: EXTRACTION OF GALL BLADDER IN LAPAROSCOPIC CHOLECYSTECTOMY: GALLBLADDER WILL BE EXTRACTED FROM EPIGASTRIC PORT IN HALF OF TOTAL PARTICIPANTS AND FROM UMBILICAL PORT IN REST HALF BY CLAS

Sponsors

UCMS GTB HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: FEMALES > 18 YEARS WITH SYMPTOMATIC CHOLELITHIASIS CONSENTING FOR INCLUSION IN STUDY AND UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. NO UPPER AGE LIMIT

Exclusion criteria

Exclusion criteria: 1) SPILLAGE / PERFORATION OF GALLBLADDER DURING DISSECTION / EXTRACTION. 2) THOSE PATIENTS IN WHOM LAPAROSCOPY IS CONVERTED IN TO OPEN CHOLECYSTECTOMY. 3) PORTAL HYPERTENSION.

Design outcomes

Primary

MeasureTime frame
1)Post-operative port site pain in epigastric and Umbilical port by NRS. 2)Gallbladder extraction time in minutes. 3)Presence or absence of local port site signs of SSI-soiling/staining of dressing,redness, induration, pus discharge, blackening of skin and incisionwound size in mm. 4)Local port site wound performance by ultrasound. 5)Patients port site wound healing satisfaction either epigastric or Umbilical scar.Timepoint: 1)Post-operative port site pain at 8, 16 and 24 hours after surgery.2)Gallbladder extraction time at on table during surgery.3)Presence or absence of local port site signs of SSI and incision wound size in mm 24 hours to 48 hours, 7th day, 15th day & 30 th day after surgery.4)ultrasound assessment of port site at 48 hours, 15 th day and 30 th day after surgery.5)Patients port site wound healing satisfaction at 30 th day after surgery. overall assessment will be done from 1st APRIL 2016—

Secondary

MeasureTime frame
1)Surgeon perception on ease of gallbladder extraction by NRS. 2)Role of obesity in gallbladder extraction.Timepoint: NIL—

Countries

India

Contacts

Public ContactDr ARUNKUMAR A

UCMS & GTB HOSPITAL DELHI

vivekgtbh@gmail.com09868399533

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026