Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.

NCT04836598 | Unknown DMC

• 1 other identifier: 11671
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 4

Brief Summary

Background: Bikini line laparoscopic cholecystectomy is a safe method, used as a scarless cosmetic port technique for gall bladder diseases in morbid obese patients as a day case. Objectives: The aim of this study was to investigate the safety and efficacy of an elective Bikini line laparoscopic cholecystectomy in the morbid obese patients with chronic calcular cholecystitis, and review our experience with Bikini line laparoscopic cholecystectomy as minimal invasive scarless technique. We issued a modifications in order to minimize the number of ports (Brief ports) and modify port sites, using the Bikini line laparoscopic cholecystectomy as a cosmetic and hidden scar laparoscopy for obese patients concerned with aesthetic results and body image. Aiming at faster recovery, decrease pain and improve cosmoses. Bikini Line laparoscopic cholecystectomy is technically safe and effective day surgery procedure for chronic cholecystitis patients with higher patient satisfaction regarding pain and cosmoses. Obesity, intended as BMI 40, does not have any obstacle on the technical feasibility of BLLC.

Conditions

Cholecystitis, Chronic

Keywords

scarless cholecystectomy; Breif port cholecystectomy

Outcome Measures

Primary Outcomes (1)

• a successful and safe day case

  a successful and safe day case laparoscopic cholecystectomy with discharge on the same day with no significant pain. patient stayed more than a day was not enrolled

  4 years

Secondary Outcomes (1)

• Measured patient satisfaction from body image and cosmoses within 6 months from surgery.

  3 years

Study Arms (2)

Multiport laparoscopic cholecystectomy

ACTIVE COMPARATOR

controlled group

Other: laparoscopic cholecystectomy

Bikini line laparoscopic cholecystectomy

ACTIVE COMPARATOR

bikini line 2 ports

Other: laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomy OTHER

A Prospective randomized controlled trial study was undertaken along 4 years Between November 2016 and October 2020, in two institutions. 400 patients were selected, 200 patients underwent BLLC and 200 patients underwent multiple port laparoscopic cholecystectomy (MPLC).

Also known as: brief port scarless laparoscopic cholecystectomy

Bikini line laparoscopic cholecystectomy; Multiport laparoscopic cholecystectomy

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3.

You may not qualify if:

• Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day.
• Patients required additional trocars for patient safety, readmission,

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (4)

Zagazig University hospitals

Zagazig, Outside USA, 12345, Egypt

RECRUITING

Zagazig University hospitals

Zagazig, Outside USA, 12345, Egypt

COMPLETED

Saudi German hospital

Riyadh, Outside USA, 11671, Saudi Arabia

RECRUITING

Saudi german hospital

Riyadh, 11671, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Cholecystitis; Bronchiolitis Obliterans Syndrome

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Bassem M Sieda, professor

  1975

  STUDY CHAIR

Central Study Contacts

Bassem M Sieda, professor

CONTACT

0541900039; drbassemmostafa@yahoo.com

Bassem M Sieda, professor

CONTACT

drbassemmostafa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of general surgeryt

Model Details: Patients were randomly allocated into 2 groups (Consort Chart) and each group categorized into 3 subgroups according to BMI, into class I: Obese Class 1 30-34.9kg/m2, Class II: Obese Class II 35-39.9kg/m2 and class III: Morbidly Obese Class III \>40kg/m2

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: November 30, 2016
• Primary Completion: April 20, 2021
• Study Completion: April 30, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: publisher which is international journa

Locations

SA (2); EG (2)