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NCT Number: NCT03477253

Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days

This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous cholecystitis in terms of conversion rates, postoperative complications and length of hospital stay within and after 3 days of symptoms onset.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, Egypt

About this study

The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as surgical management of acute calculous cholecystitis within and after 72h of symptom onset.

This study included 62 patients with acute calculous cholecystitis. Patients are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms and categorized as Group A & B. Immediate laparoscopic cholecystectomy is performed in Group A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups monitored since admission, during operations, and along the postoperative period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Abdominal pain characteristic of Acute Cholecystitis, Positive Murphy's sign, Total Leucocyte Count > 10,000/ uL, and (4) Ultra-sonographic evidence of Acute Calculous Cholecystitis.
  • Initial surgical management planned for immediate laparoscopic cholecystectomy.
  • Patients who are fit for laparoscopy and general anesthesia.
  • Patient who agree to provide short term outcome data and agree to provide contact information.

Exclusion criteria

  • Patients with ultra-sonographic findings of common bile duct calculi, pancreatitis, gall bladder perforation, gall bladder gangrene or gall bladder abscess.
  • Patients with other associated abdominal pathology.
  • Patients with any previous abdominal surgery or any significant systemic disease.
  • Septic shock.
  • Pregnancy/ Breast-feeding mothers.
  • Participation in an additional drug or device study and inability to offer informed consent.

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits

Primary outcomes

  1. Comparison between early and late laparoscopic cholecystectomy regarding Operation time

    Time frame: intra-operative

    comparing the needed intra-operative time for laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis , time will be measured by minutes

  2. Comparison between early and late laparoscopic cholecystectomy regarding difficulty of operation

    Time frame: intra-operative

    comparing the difficulty of laparoscopic cholecystectomy within and after 3 days of the onset of acute calculous cholecystitis, difficulty will be assessed by the rate of conversion to open cholecystectomy

  3. comparison between early and late laparoscopic cholecystectomy regarding post operative pain

    Time frame: within 1month post operative

    comparing between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and duration of post operative pain , pain will be measured by either the pain responded to regular NSAIDs or needed the administration of narcotics

  4. Duration of postoperative hospital stay

    Time frame: within 2 weeks post-operative

    comparing post-operative duration of hospital stay after laparoscopic cholecystectomy within and after 3 days of the onset of acute calcular cholecystitis ,duration will be measured by post operative days spent in the hospital

Secondary outcomes

  1. comparison between early and late laparoscopic cholecystectomy regarding post operative bile leakage

    Time frame: first 72 hours post-operative

    compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of bile leakage

  2. comparison between early and late laparoscopic cholecystectomy regarding post operative bleeding

    Time frame: 7 days postoperative

    compare between laparoscopic cholecystectomy within and after 3 days of the onset of acute cholecystitis regarding the presence and amount of postoperative bleeding

  3. presence of any wound complication by examining the wound

    Time frame: within 10 days post-operative

    comparison between early and late laparoscopic cholecystectomy concerning the presence and rate of wound infection by clinical examination post-operative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Laparoscopic Cholecystectomy for Management of Acute Calculous Cholecystitis Within Versus After 3 Days of Disease Onset

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2018
Registry last updated
Apr 28, 2021

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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