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OpenTrials
Completed

NCT Number: NCT03999645

Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?

Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).

Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack.

Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with AC within seven days from symptom onset
  • American Society of Anesthesiologist (ASA) physical status ≤ II
  • Age from 21 to 60 years

Exclusion criteria

  • Patients with ASA physical status > II
  • Age < 21 years or > 60 years
  • Child classification B or C
  • Choledocholithiasis
  • Acute pancreatitis
  • Severe sepsis
  • Gallbladder perforation
  • Pregnant women

Treatment and study plan

Early Laparoscopic Cholecystectomy

Procedure

within 72h from symptom onset

Late laparoscopic cholecystectomy

Procedure

after 72h up to seven days from symptom onset

Primary outcomes

  1. Number of participants and Rate of Post-operative complications

    Time frame: 30 days post-operatively

    Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate

Secondary outcomes

  1. Mean and Standard deviation of Operative duration (hours) (mean±SD)

    Time frame: from surgical incision till suture closure

    Mean and Standard deviation of Operative duration (hours)

  2. Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)

    Time frame: from surgical incision till suture closure

    Mean and Standard deviation of Intra-operative blood loss (ml)

  3. Number of participants and Rate of Conversion to open cholecystectomy

    Time frame: from the start till the end of surgical procedure

    Number of participants and Rate of Conversion to open cholecystectomy

  4. Mean and Standard deviation of Length of hospital stay (days) (mean±SD)

    Time frame: from hospital admission till home discharge within 30 days

    Mean and Standard deviation of Length of hospital stay (days)

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Official study title

Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial

Acronym: RCT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2019
Registry last updated
Jun 27, 2019

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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