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

• Sponsor: Damanhour Teaching Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03999645
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis	Procedure: Early laparoscopic cholecystectomy; Procedure: Late laparoscopic cholecystectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group E: Early LC (n=60) Early laparoscopic cholecystectomy (within 72h from symptom onset)	Procedure: Early laparoscopic cholecystectomy; within 72h from symptom onset
Active Comparator: Group L: Late LC (n=60) Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)	Procedure: Late laparoscopic cholecystectomy; after 72h up to seven days from symptom onset

Outcome Measures

Primary Outcome Measures

1. Number of participants and Rate of Post-operative complications [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 Outcome Measures

1. Mean and Standard deviation of Operative duration (hours) (mean±SD) [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) [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 [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) [from hospital admission till home discharge within 30 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damanhour Teaching Hospital	Damanhūr	El-Beheira	Egypt

Sponsors and Collaborators

• Damanhour Teaching Hospital

Investigators

• Principal Investigator: Mohamed M Abdalgaleil, MD, Damanhour Teaching Hospital
• Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital
• Study Director: Osama S Elbalky, MD, Damanhour Teaching Hospital
• Study Chair: Mamdouh M Ibrahim, MD, Damanhour Teaching Hospital
• Study Chair: Mohamed S Elnagar, MD, Damanhour Teaching Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Damanhour Teaching Hospital
• ClinicalTrials.gov Identifier: NCT03999645
• Other Study ID Numbers: DTH:19002
• First Posted: Jun 27, 2019
• Last Update Posted: Jun 27, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Damanhour Teaching Hospital: Acute cholecystitis; Early laparoscopic cholecystectomy; Gallbladder disease; Late laparoscopic cholecystectomy
• Additional relevant MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute

Study Results

No Results Posted as of Jun 27, 2019