Brief Title
Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
Official Title
Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
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.
Detailed Description
Thoroughly, BLLC is a novel technique aimed at solving the issue of cosmoses that is always presented as a main complaint from morbid obese patients. The main concern to use Brief ports laparoscopy or hidden scar laparoscopy to reduce incisions and change sites. The study designed to identify superiority of technique regarding success as a day case surgery, better cosmoses and lesser pain. We tried to wear off the port sites scar and kept our stabs in the suprapubic Bikin line. We kept camera port in the navel's natural scar and used the other ports in lower abdominal crease at Bikini line. Cosmosis has been and still the reason among patient population to accept the laparoscopic surgery, many synonyms can be applied here, as Cosmotic,Hidden scar, Scarless, Non-visualized or Scarless Bikini cholecystectomy. BLLC is performed under general anesthesia. Patient placed in the supine position with patient's legs apart and arms are rolled in, patient strapped to table at the mid-thigh. Surgeon stood between patient's legs, the camera man stood on the right side of patient, monitor placed near patient head to the right side. Three ports were used, 12 mm visiport (….) umbilical, with A 30 degree camera used, 5mm in Bikini line at Right mid-clavicular line and third port 5mm in Bikini line at left mid-clavicular line (Figure) Patient kept in reverse Trendlenburg position with maximum degree 20. But to lesser degree than done in classic LC,
Study Type
Interventional
Primary Outcome
a successful and safe day case
Secondary Outcome
Measured patient satisfaction from body image and cosmoses within 6 months from surgery.
Condition
Cholecystitis, Chronic
Intervention
laparoscopic cholecystectomy
Study Arms / Comparison Groups
Multiport laparoscopic cholecystectomy
Description: controlled group
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
3
Start Date
November 30, 2016
Completion Date
April 30, 2021
Primary Completion Date
April 20, 2021
Eligibility Criteria
Inclusion Criteria: - Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3. Exclusion Criteria: - Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day. Patients required additional trocars for patient safety, readmission,
Gender
All
Ages
17 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Bassem M Sieda, professor, 0541900039, [email protected]
Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT04836598
Organization ID
11671
Responsible Party
Principal Investigator
Study Sponsor
Zagazig University
Study Sponsor
Bassem M Sieda, professor, Study Chair, 1975
Verification Date
April 2021