Cholecystitis, ChronicNCT04836598
Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
A study testing laparoscopic cholecystectomy in people with Cholecystitis, Chronic, run by Zagazig University at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Cholecystitis, Chronic
- What is being tested?
- laparoscopic cholecystectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Nov 2016to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3.
Who cannot join
- Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day.
- Patients required additional trocars for patient safety, readmission,
Trial locations and contacts
4 sites in 2 countries.
Bassem M Sieda, professor contact
4 sites in 2 countries
Egypt2 sites, 1 recruiting
- Recruiting
Zagazig University hospitals
Zagazig, Outside USA, 12345
Bassem M Sieda, professor, drbassemmostafa@yahoo.com
Bassem M Sieda, drbassemmostafa@yahoo.com
- Completed
Zagazig University hospitals
Zagazig, Outside USA, 12345
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Saudi German hospital
Riyadh, Outside USA, 11671
Bassem M Sieda, 0541900039, drbassemmostafa@yahoo.com
- Recruiting
Saudi german hospital
Riyadh, 11671
Bassem M Sieda, 00966541900039 ext. 00966541900039, drbassemmostafa@yahoo.com
About this study
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:
Read more
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.
Read the 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,
- Conditions
- Cholecystitis, Chronic
- Being tested
- laparoscopic cholecystectomy
- Keywords
- scarless cholecystectomy, Breif port cholecystectomy
- Medical subject headings
- Cholecystitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic cholecystectomyOther
Also called brief port scarless laparoscopic cholecystectomy
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).
| Study group | Role | What they receive |
|---|---|---|
| Multiport laparoscopic cholecystectomy | Active comparator | controlled group Receives: Other: laparoscopic cholecystectomy |
| Bikini line laparoscopic cholecystectomy | Active comparator | bikini line 2 ports Receives: Other: laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (1)
Measured patient satisfaction from body image and cosmoses within 6 months from surgery.
Postoperative pain was defined as mild, moderate sever according to visual analogue scale (VAS)
Pain assessment at the tommy and at port sites were assessed at postoperative day 1 and at discharge as follow, 8 hours, at discharge time at 12 hours or 24 hours postoperative, and after discharge at 48 hours, 72 hours achieved through Telephone call with the patient.
Patient satisfaction from cosmetic outcome was measured on 10 points scale. Divided into mild satisfied (1-3 points), moderate (4-7)and highly satisfied (8-10 points) at the second postoperative visit at 30 days postoperative, after 3 months and after 6 months, based on patient question to rate it, mild satisfaction: 1-3, moderate satisfaction:4-7 and highly satisfied: from 8-10
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start30 Nov 2016
- Primary completion20 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, ChronicStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bassem Mohamed Sieda, Zagazig University
- Investigators
- Bassem M Sieda, professor, Study chair, 1975
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836598
- Sponsor's protocol ID
- 11671
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data can be shared through the publisher and all authers
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
- ClinicalTrials.gov ID
- NCT04836598
- Acronym / sponsor ID
- 11671
- Conditions
- Cholecystitis, Chronic
- Keywords
- scarless cholecystectomy, Breif port cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Multiport laparoscopic cholecystectomy | Active comparator | Other: laparoscopic cholecystectomycontrolled group |
| Bikini line laparoscopic cholecystectomy | Active comparator | Other: laparoscopic cholecystectomybikini line 2 ports |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3.
Key exclusion criteria (2 listed)
- Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day.
- Patients required additional trocars for patient safety, readmission,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic cholecystectomyAlso: brief port scarless laparoscopic cholecystectomyA 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). | Other | Bikini line laparoscopic cholecystectomy, Multiport laparoscopic cholecystectomy |
Primary outcome
a successful and safe day case
Time frame: 4 years
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
1 secondary outcome
Measured patient satisfaction from body image and cosmoses within 6 months from surgery.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Yes. data can be shared through the publisher and all authers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem M Sieda, professor contact
Bassem M Sieda, professor study chair
1975
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic cholecystectomy in people with Cholecystitis, Chronic, run by Zagazig University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassem M Sieda, professor (0541900039, drbassemmostafa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a successful and safe day case (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.