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

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 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

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