Clinical trial NCT04836598: Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
Official title: Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis, Chronic
Keywords: scarless cholecystectomy
Breif port cholecystectomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-04-08
Enrollment: 3
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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,

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,

Primary outcomes:
measure: a successful and safe day case
timeFrame: 4 years
Secondary outcomes:
measure: Measured patient satisfaction from body image and cosmoses within 6 months from surgery.
timeFrame: 3 years
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University hospitals
state: Outside USA
city: Zagazig
country: Egypt
facility: Zagazig University hospitals
state: Outside USA
city: Riyadh
country: Saudi Arabia
facility: Saudi German hospital
state: Outside USA
city: Riyadh
country: Saudi Arabia
facility: Saudi german hospital
Study officials:
affiliation: 1975
name: Bassem M Sieda, professor
role: STUDY_CHAIR
References: