UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057612 |
|---|---|
| Receipt number | R000065781 |
| Scientific Title | Acute postoperative pain comparing robotic versus laparoscopic surgery in bariatric procedures |
| Date of disclosure of the study information | 2025/04/21 |
| Last modified on | 2025/04/15 03:00:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Acute postoperative pain comparing robotic versus laparoscopic surgery in bariatric procedures
Acronym
DOROB-LABA
Scientific Title
Acute postoperative pain comparing robotic versus laparoscopic surgery in bariatric procedures
Scientific Title:Acronym
PAIN-ROBO-LABA
Region
| North America |
Condition
Condition
Patients undergoing laparoscopic or robot-assisted bariatric surgery (Sleeve Gastrectomy, Gastric Bypass, Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy).
To reduce variability and ensure consistency across the study population, all patients included in the analysis must have received the following standardized analgesic and antiemetic regimen:
Analgesic intraoperative protocol:
Ketorolac 30 mg IV
Dexamethasone 8 mg IV
Buprenorphine 300 mcg IV
Antiemetic protocol:
Aprepitant 80 mg PO preoperatively
Ondansetron 8 mg IV intraoperatively
Rescue analgesia protocol:
Buprenorphine 1 mcg/kg IV
Classification by specialty
| Surgery in general | Anesthesiology | Operative medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify which surgical approach (robotic or laparoscopic) is associated with lower levels of acute postoperative pain, measured using the Numeric Rating Scale (NRS), in patients undergoing bariatric procedures, including Sleeve Gastrectomy, Gastric Bypass, and Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S). Pain will be evaluated at 1, 8, and 24 hours postoperatively, and at the time of hospital discharge.
Basic objectives2
Others
Basic objectives -Others
1.- To compare acute postoperative pain intensity between robotic and laparoscopic surgery in patients undergoing bariatric procedures, including Sleeve Gastrectomy, Gastric Bypass, and Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S), measured by the Numeric Rating Scale (NRS) at 1, 8, and 24 hours postoperatively, and at hospital discharge.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Intensity of acute postoperative pain, measured by the Numeric Rating Scale (NRS) at 1 hour postoperatively, comparing patients undergoing robotic versus laparoscopic bariatric surgery, including Sleeve Gastrectomy, Gastric Bypass, and Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S).
Key secondary outcomes
1.- Time to first rescue analgesia, defined as the time interval (in minutes or hours) between the end of surgery and the first administration of rescue pain medication.
2.- Pain intensity at 8 hours postoperatively, measured using the Numeric Rating Scale (NRS).
3.- Pain intensity at 24 hours postoperatively, measured using the Numeric Rating Scale (NRS).
4.- Pain intensity at hospital discharge, measured using the Numeric Rating Scale (NRS).
5.- Length of hospital stay, measured in hours or days from the end of surgery to hospital discharge.
6.- Incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after surgery.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.- Patients over 18 years of age
2.- Patients of both genders
3.- Patients admitted to bariatric surgery
4.- Complete file
Key exclusion criteria
1.- Files with incomplete data
2.- File with a voluntary discharge form or transfer note
3.- Patients who need to be intubated in intensive care after surgery
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Manuel |
| Middle name | |
| Last name | Guerrero |
Organization
Hospital de Prado Medical Center
Division name
Department of Bariatric Surgery
Zip code
22105
Address
Bugambilias #50, Fraccionamiento el Prado, Tijuana Baja California
TEL
+526642746273
manuelguerreromd@gmail.com
Public contact
Name of contact person
| 1st name | Diego |
| Middle name | |
| Last name | Escarraman |
Organization
Instituto Mexicano del Seguro Social
Division name
Anesthesiology Department
Zip code
02990
Address
Paseo de las Jacarandas Sin Numero, Colonia La Raza, Azcapotzalco, Ciudad de Mexico
TEL
+525570778209
Homepage URL
diego-piloto@hotmail.com
Sponsor or person
Institute
Hospital de Prado Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical teaching and research, Hospital de Prado Medical Center
Address
Bugambilias #50, Fraccionamiento el Prado, Tijuana Baja California
Tel
+528114837002
arellanespaloma@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study based on the analysis of electronic medical records from patients who underwent bariatric surgery using either a robotic or laparoscopic approach. The study aims to compare the postoperative pain perceived by patients between both surgical techniques. Patients will be stratified according to the type of approach used. The bariatric procedures included in the study are Sleeve Gastrectomy, Gastric Bypass, and Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S).
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065781
